A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease (FORTIFY)

August 11, 2025 updated by: AbbVie

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease

The study consists of 4 sub-studies, as follows:

Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;
Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;
Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.
OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

Study Overview

Status

Active, not recruiting

Conditions

Crohn's Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1336

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Cordoba, Argentina, 5016
    - Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 168076
- Buenos Aires
  - Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1431
    - Cemic /Id# 168078
  - Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, 1280
    - Hospital Britanico de Buenos Aires /ID# 168077
- Santa Fe
  - Rosario, Santa Fe, Argentina, 2000
    - Hospital Provincial del Centenario /ID# 170886
Australia
- Queensland
  - South Brisbane, Queensland, Australia, 4101
    - Mater Misericordiae Limited /ID# 167220
  - Southport, Queensland, Australia, 4222
    - Griffith University /ID# 212635
- South Australia
  - Elizabeth Vale, South Australia, Australia, 5112
    - Lyell McEwin Hospital /ID# 212215
- Victoria
  - Camberwell, Victoria, Australia, 3124
    - Emeritus Research /ID# 213512
Austria
- Niederoesterreich
  - Sankt Poelten, Niederoesterreich, Austria, 3100
    - Universitaetsklinikum St. Poelten /ID# 166424
- Steiermark
  - Graz, Steiermark, Austria, 8010
    - Medizinische Universitaet Graz /ID# 158140
- Wien
  - Vienna, Wien, Austria, 1020
    - Krankenhaus der Barmherzigen Brueder Wien /ID# 212060
  - Vienna, Wien, Austria, 1090
    - Medizinische Universitaet Wien /ID# 158141
Belarus
- - Gomel, Belarus, 246029
    - Gomel Regional Clinical Hospital /ID# 205112
  - Витебск, Belarus, 210001
    - Vitebsk Regional Advanced Clin /ID# 206778
- Grodnenskaya Oblast
  - Grodno, Grodnenskaya Oblast, Belarus, 230011
    - Grodno city clinical hospital #2 /ID# 205113
Belgium
- - Gent, Belgium, 9000
    - AZ Maria Middelares /ID# 213532
  - Kortrijk, Belgium, 8500
    - AZ Groeninge /ID# 211513
  - Liege, Belgium, 4000
    - CHU de Liege /ID# 157409
- Antwerpen
  - Bonheiden, Antwerpen, Belgium, 2820
    - Imelda Ziekenhuis /ID# 157403
  - Mechelen, Antwerpen, Belgium, 2800
    - AZ Sint-Maarten /ID# 212876
  - Merksem, Antwerpen, Belgium, 2170
    - ZAS Palfijn /ID# 212877
- Bruxelles-Capitale
  - Anderlecht, Bruxelles-Capitale, Belgium, 1070
    - Universite Libre de Bruxelles - Hopital Erasme /ID# 157408
  - Bruxelles, Bruxelles-Capitale, Belgium, 1200
    - Cliniques Universitaires UCL Saint-Luc /ID# 157406
- Liege
  - Liège, Liege, Belgium, 4000
    - Groupe Sante CHC - Clinique du MontLegia /ID# 157404
- Namur
  - Yvoir, Namur, Belgium, 5530
    - Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 157412
- Oost-Vlaanderen
  - Gent, Oost-Vlaanderen, Belgium, 9000
    - UZ Gent /ID# 157405
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - Universitair Ziekenhuis Leuven /ID# 157407
- West-Vlaanderen
  - Roeselare, West-Vlaanderen, Belgium, 8800
    - AZ-Delta /ID# 157402
Bosnia and Herzegovina
- - Sarajevo, Bosnia and Herzegovina, 71000
    - Clinical Center University of Sarajevo /ID# 165139
- Republika Srpska
  - Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
    - Klinicki centar Banja Luka /ID# 164513
Bulgaria
- - Pleven, Bulgaria, 5800
    - UMHAT Dr Georgi Stranski EAD /ID# 203976
  - Plovdiv, Bulgaria, 4001
    - Umbal Kaspela /ID# 165700
  - Sofia, Bulgaria, 1407
    - Tokuda Hospital Sofia /ID# 165701
  - Sofia, Bulgaria, 1431
    - UMHAT Sveti Ivan Rilski /ID# 204815
  - Sofia, Bulgaria, 1202
    - 2nd Mhat /ID# 165702
  - Sofia, Bulgaria, 1527
    - Duplicate_UMHAT Tsaritsa Joanna - ISUL /ID# 211242
  - Stara Zagora, Bulgaria, 6004
    - MHAT Trakia /ID# 201668
Canada
- - Greenfield Park, Canada, J4V 2H1
    - CISSS de la Monteregie Centre - Hopital Charles Le Moyne /ID# 161630
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - University of Calgary /ID# 157155
  - Edmonton, Alberta, Canada, T5R 1W2
    - Allen Whey Khye Lim Professional Corporation /ID# 169763
  - Edmonton, Alberta, Canada, T6K 4B2
    - Covenant Health /ID# 161632
  - Edmonton, Alberta, Canada, T6G 2B7
    - University of Alberta Hospital /ID# 157099
- British Columbia
  - New Westminster, British Columbia, Canada, V3L 3W4
    - Fraser Clinical Trials Inc /ID# 159055
  - Vancouver, British Columbia, Canada, V5Z 2K5
    - Giri Gi Research Institute - Vancouver /ID# 157096
  - Victoria, British Columbia, Canada, V8V 3M9
    - Percuro Clinical Research, Ltd /ID# 161631
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3K 6R8
    - IWK Health Center /ID# 165905
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 157088
- Ontario
  - Hamilton, Ontario, Canada, L8S 4K1
    - Duplicate_Hamilton Health Sciences -McMaster University Medical Centre /ID# 157184
  - London, Ontario, Canada, N6A 5W9
    - London Health Sciences Center- University Hospital /ID# 157161
  - North Bay, Ontario, Canada, P1B 2H3
    - Scott Shulman Medicine Professional Corporation /ID# 165906
  - Sudbury, Ontario, Canada, P3A 1W8
    - Medicor Research Inc /ID# 157150
  - Toronto, Ontario, Canada, M5G 1X5
    - Mount Sinai Hospital /ID# 169764
  - Vaughan, Ontario, Canada, L4L 4Y7
    - Toronto Digestive Disease Associates /ID# 157158
- Quebec
  - Lévis, Quebec, Canada, G6V 3Z1
    - Hotel Dieu de Levis /ID# 214377
  - Montreal, Quebec, Canada, H1T 2M4
    - CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159056
  - Montreal, Quebec, Canada, H3G 1A4
    - Montreal General Hospital- McGill University Health Center /ID# 157085
Chile
- Bio-Bio
  - Concepción, Bio-Bio, Chile, 4070038
    - Hospital Guillermo Grant Benavente de Concepción /ID# 210760
  - Talcahuano, Bio-Bio, Chile, 1740000
    - Hospital Las Higueras /ID# 167092
- Region Metropolitana De Santiago
  - Santiago, Region Metropolitana De Santiago, Chile, 8207257
    - Complejo Asistencial Dr. Sotero del Rio /ID# 169384
- Region Metropolitana Santiago
  - Santiago, Region Metropolitana Santiago, Chile, 8350488
    - Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171122
China
- Guangdong
  - Guangzhou, Guangdong, China, 510080
    - Guangdong Provincial People's Hospital /ID# 212949
  - Guangzhou, Guangdong, China, 510655
    - The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 210784
- Hebei
  - Shijiazhuang, Hebei, China, 050000
    - The Second Hospital of Hebei Medical University /ID# 212738
- Hubei
  - Wuhan, Hubei, China, 430022
    - Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211039
  - Wuhan, Hubei, China, 430060
    - Renmin Hospital of Wuhan University /ID# 214874
  - Wuhan, Hubei, China, 430030
    - Tongji Hospital Tongji Medical College of HUST /ID# 210858
- Hunan
  - Changsha, Hunan, China, 410011
    - The Second Xiangya Hospital of Central South University /ID# 211700
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - The First Affiliated Hospital of Nanchang University /ID# 211036
- Shanghai
  - Shanghai, Shanghai, China, 200065
    - Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210840
  - Shanghai, Shanghai, China, 200127
    - Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210705
  - Shanghai, Shanghai, China, 200136
    - Shanghai East Hospital /ID# 212684
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - West China Hospital, Sichuan University /ID# 210890
- Tianjin
  - Tianjin, Tianjin, China, 300052
    - Tianjin Medical University General Hospital /ID# 210926
- Zhejiang
  - Hangzhou, Zhejiang, China, 310009
    - The second affiliated hospital of Zhejiang University school of medicine /ID# 210724
  - Hangzhou, Zhejiang, China, 310020
    - Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210625
  - Jinhua, Zhejiang, China, 321000
    - Jinhua Municipal Central Hospital /ID# 215628
Colombia
- Antioquia
  - Medellin, Antioquia, Colombia, 050024
    - Instituto de Coloproctologia /ID# 158743
  - Medellin, Antioquia, Colombia, 50010
    - Hospital Universitario San Vic /ID# 171486
  - Medellín, Antioquia, Colombia, 050034
    - Hospital Pablo Tobón Uribe /ID# 158730
- Cundinamarca
  - Bogota, Cundinamarca, Colombia, 110231
    - Hospital Univ San Ignacio /ID# 158734
Croatia
- - Zadar, Croatia, 23000
    - Zadar General Hospital /ID# 157563
- Grad Zagreb
  - Zagreb, Grad Zagreb, Croatia, 10000
    - Klinicka bolnica Dubrava Zagreb /ID# 157560
  - Zagreb, Grad Zagreb, Croatia, 10000
    - Klinicki bolnicki centar Sestre milosrdnice /ID# 157728
  - Zagreb, Grad Zagreb, Croatia, 10000
    - Klinicki bolnicki centar Zagreb /ID# 157561
- Osjecko-baranjska Zupanija
  - Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
    - Poliklinika Borzan d.o.o. /ID# 157559
- Splitsko-dalmatinska Zupanija
  - Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
    - Klinicki Bolnicki Centar (KBC) Split /ID# 157562
Czechia
- - Hradec Kralove, Czechia, 500 12
    - Hepato-Gastroenterologie HK, s.r.o. /ID# 163225
  - Pardubice, Czechia, 530 03
    - Nemocnice Pardubickeho kraje, a.s. /ID# 163226
  - Praha, Czechia, 118 33
    - Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211306
  - Praha, Czechia, 140 00
    - Axon Clinical, s.r.o. /ID# 163223
  - Praha, Czechia, 140 59
    - Fakultni Thomayerova nemocnice /ID# 162941
  - Praha, Czechia, 143 00
    - ResTrial s.r.o. /ID# 211078
  - Praha, Czechia, 155 00
    - Nemocnice Horovice - NH Hospital a.s /ID# 211077
- Praha 4
  - Prague 4, Praha 4, Czechia, 140 00
    - Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165465
- Praha 9
  - Prague, Praha 9, Czechia, 190 00
    - Iscare Klinické Centrum /ID# 225794
Denmark
- Hovedstaden
  - Hvidovre, Hovedstaden, Denmark, 2650
    - Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155530
- Midtjylland
  - Aarhus, Midtjylland, Denmark, 8200
    - Aarhus Universitetshospital - Skejby /ID# 155664
- Sjælland
  - Roskilde, Sjælland, Denmark, 4000
    - Roskilde Sygehus /ID# 155532
- Syddanmark
  - Nyborg, Syddanmark, Denmark, 5800
    - Sygehusenheden Nyborg - OUH /ID# 161525
  - Odense, Syddanmark, Denmark, 5000
    - Odense University Hospital /ID# 155531
Egypt
- - Al Sharqia, Egypt, 44519
    - Zagazig University Hospitals /ID# 164539
  - Cairo, Egypt, 11559
    - Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157175
  - Cairo, Egypt, 11559
    - National Hepatology and Tropical Medicine Research Institute /ID# 157874
  - Cairo, Egypt, 11566
    - Duplicate_Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 157506
- Al Iskandariyah
  - Alexandria, Al Iskandariyah, Egypt, 21131
    - Alexandria University /ID# 157187
  - Alexandria, Al Iskandariyah, Egypt, 21131
    - Alexandria University /ID# 164540
Estonia
- - Tallinn, Estonia, 10138
    - East Tallinn Central Hospital /ID# 157074
- Harjumaa
  - Mustamäe Linnaosa, Harjumaa, Estonia, 13419
    - North Estonia Medical Centre /ID# 164326
  - Tallinn, Harjumaa, Estonia, 10617
    - West Tallinn Central Hospital /ID# 157075
France
- - Rennes, France, 35033
    - CHRU Pontchaillou /ID# 213209
- Alpes-Maritimes
  - Nice, Alpes-Maritimes, France, 06202
    - Chu de Nice-Hopital L'Archet Ii /Id# 162557
- Gironde
  - Pessac CEDEX, Gironde, France, 33604
    - Centre Hospitalier Universitaire de Bordeaux /ID# 162558
- Herault
  - Montpellier Cedex 5, Herault, France, 34295
    - CHU Montpellier - Hopital Saint Eloi /ID# 215147
- Ile-de-France
  - Clichy, Ile-de-France, France, 92110
    - Hopital Beaujon /ID# 166284
  - Neuilly Sur Seine, Ile-de-France, France, 92200
    - Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249858
- Isere
  - La Tronche, Isere, France, 38700
    - Duplicate_CHU Grenoble - Hopital Michallon /ID# 212834
- Loire
  - St-Priest-en-Jarez, Loire, France, 42270
    - Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 162562
- Meurthe-et-Moselle
  - Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
    - CHRU Nancy - Hopitaux de Brabois /ID# 162561
- Nord
  - Lille, Nord, France, 59037
    - CHRU Lille - Hopital Claude Huriez /ID# 162559
- Rhone
  - Pierre Benite CEDEX, Rhone, France, 69495
    - HCL - Hopital Lyon Sud /ID# 162560
- Somme
  - Amiens CEDEX 1, Somme, France, 80054
    - CHU Amiens-Picardie Site Sud /ID# 165058
Germany
- - Berlin, Germany, 10787
    - Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211974
  - Berlin, Germany, 10825
    - MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159350
  - Berlin, Germany, 14050
    - DRK Kliniken Berlin Westend /ID# 166151
  - Berlin, Germany, 10117
    - Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212220
  - Berlin, Germany, 10117
    - Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212894
  - Berlin-Zehlendorf, Germany, 14163
    - Krankenhaus Waldfriede /ID# 212727
  - Braunschweig, Germany, 38126
    - Stadtisches Klinikum Braunschweig /ID# 163680
  - Magdeburg, Germany, 39120
    - Universitaetsklinikum Magdeburg /ID# 211843
  - Regensburg, Germany, 93042
    - Universitaetsklinikum Regensburg /ID# 163813
- Baden-Wuerttemberg
  - Freiburg, Baden-Wuerttemberg, Germany, 79106
    - Universitaetsklinikum Freiburg /ID# 162030
  - Heidelberg, Baden-Wuerttemberg, Germany, 69121
    - Praxis fuer Gastroenterologie /ID# 166150
  - Mannheim, Baden-Wuerttemberg, Germany, 68167
    - Universitatsklinikum Mannheim /ID# 162031
  - Ulm, Baden-Wuerttemberg, Germany, 89081
    - Universitaetsklinikum Ulm /ID# 164990
- Bayern
  - Dachau, Bayern, Germany, 85221
    - Medizinisches Versorgunszentrum Dachau /ID# 211555
  - Erlangen, Bayern, Germany, 91054
    - Universitaetsklinikum Erlangen /ID# 159343
- Hessen
  - Frankfurt am Main, Hessen, Germany, 60590
    - Universitaetsklinikum Frankfurt /ID# 212979
  - Frankfurt am Main, Hessen, Germany, 60431
    - Duplicate_Agaplesion Markus Krankenhaus /ID# 159345
- Niedersachsen
  - Hannover, Niedersachsen, Germany, 30625
    - Medizinische Hochschule Hannover /ID# 162032
  - Lueneburg, Niedersachsen, Germany, 21339
    - Klinikum Lueneburg /ID# 163678
- Nordrhein-Westfalen
  - Cologne, Nordrhein-Westfalen, Germany, 51103
    - Evangelisches Krankenhaus Kalk /ID# 212726
  - Grevenbroich, Nordrhein-Westfalen, Germany, 41515
    - Praxiszentrum fuer Gastroenterologie /ID# 211966
  - Köln, Nordrhein-Westfalen, Germany, 50937
    - Universitaetsklinikum Koeln /ID# 164989
  - Minden, Nordrhein-Westfalen, Germany, 32423
    - Gastroenterologische Gemeinschaftspraxis Minden /ID# 162029
  - Muenster, Nordrhein-Westfalen, Germany, 48149
    - Universitaetsklinikum Muenster /ID# 159344
- Saarland
  - Saarbrücken, Saarland, Germany, 66111
    - Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210528
- Sachsen
  - Leipzig, Sachsen, Germany, 04103
    - Eugastro /ID# 212078
- Schleswig-Holstein
  - Kiel, Schleswig-Holstein, Germany, 24105
    - Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159349
- Thueringen
  - Jena, Thueringen, Germany, 07747
    - Universitaetsklinikum Jena /ID# 159351
Greece
- - Athens, Greece, 10676
    - General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157423
  - Ioannina, Greece, 45500
    - University General Hospital of Ioannina /ID# 157420
  - Thessaloniki, Greece, 54639
    - Theageneio Anticancer Hospital /ID# 163897
- Attiki
  - Athens, Attiki, Greece, 11527
    - General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170914
  - Nikaia, Attiki, Greece, 18454
    - General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 157424
  - Piraeus, Attiki, Greece, 18536
    - Tzaneio general hospital of Piraeus /ID# 206443
- Kriti
  - Heraklion, Kriti, Greece, 71500
    - University General Hospital of Heraklion PA.G.N.I /ID# 157422
Hong Kong
- - Hong Kong, Hong Kong, 999077
    - Queen Mary Hospital /ID# 163923
  - Hong Kong, Hong Kong
    - Tuen Mun Hospital /ID# 163905
Ireland
- - Galway, Ireland, H91 YR71
    - University Hospital Galway /ID# 157541
- Dublin
  - Beaumont, Dublin, Ireland, D09 XR63
    - Duplicate_Beaumont Hospital /ID# 157543
  - Elm Park, Dublin, Ireland, D04 T6F4
    - St Vincent's University Hospital /ID# 157540
Israel
- - Haifa, Israel, 3109601
    - Duplicate_Rambam Medical Center /ID# 171067
- HaDarom
  - Ashkelon, HaDarom, Israel, 5822000
    - The Edith Wolfson Medical Center /ID# 217331
  - Be'er Sheva, HaDarom, Israel, 8443901
    - Soroka University Medical Center /ID# 157794
- Tel-Aviv
  - Ramat Gan, Tel-Aviv, Israel, 5265601
    - The Chaim Sheba Medical Center /ID# 157793
  - Ramat Gan, Tel-Aviv, Israel, 5265601
    - The Chaim Sheba Medical Center /ID# 171069
  - Tel Aviv, Tel-Aviv, Israel, 6423906
    - Tel Aviv Sourasky Medical Center /ID# 157792
- Yerushalayim
  - Jerusalem, Yerushalayim, Israel, 91120
    - Hadassah Medical Center-Hebrew University /ID# 165914
  - Jerusalem, Yerushalayim, Israel, 91031
    - Shaare Zedek Medical Center /ID# 163541
  - Jerusalem, Yerushalayim, Israel, 91031
    - Shaare Zedek Medical Center /ID# 171068
Italy
- - Bologna, Italy, 40138
    - IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 155643
  - Catania, Italy, 95126
    - Ospedale Cannizzaro /ID# 161300
  - Catanzaro, Italy, 88100
    - Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 212016
  - Milano, Italy, 20122
    - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 155641
  - Modena, Italy, 41124
    - Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212028
  - Palermo, Italy, 90146
    - Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 155645
  - Pavia, Italy, 27100
    - Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212031
- Ancona
  - Torrette, Ancona, Italy, 60123
    - Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162436
- Genova
  - Genoa, Genova, Italy, 16132
    - Duplicate_Ospedale Policlinico San Martino /ID# 162439
- Lombardia
  - Rozzano, Lombardia, Italy, 20089
    - IRCCS Istituto Clinico Humanitas /ID# 155642
- Milano
  - Milan, Milano, Italy, 20157
    - ASST Fatebenefratelli Sacco /ID# 155639
  - Rho, Milano, Italy, 20017
    - ASST Rhodense/Presidio Ospedaliero di Rho /ID# 212227
- Roma
  - Rome, Roma, Italy, 00168
    - Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155640
  - Rome, Roma, Italy, 00133
    - Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158022
  - Rome, Roma, Italy, 00161
    - Duplicate_Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166912
  - Rome, Roma, Italy, 00128
    - Duplicate_Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 162438
  - Rome, Roma, Italy, 00149
    - Azienda Ospedaliera San Camillo Forlanini /ID# 155644
- Toscana
  - Florence, Toscana, Italy, 50139
    - Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 167992
- Verona
  - Negrar, Verona, Italy, 37024
    - IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161299
Japan
- Aichi
  - Nagakute, Aichi, Japan, 480-1195
    - Aichi Medical University Hospital /ID# 160097
  - Nagoya shi, Aichi, Japan, 467-8602
    - Nagoya City University Hospital /ID# 160100
  - Nagoya-shi, Aichi, Japan, 466-8560
    - Nagoya University Hospital /ID# 160116
  - Nagoya-shi, Aichi, Japan, 457-8511
    - Daido Clinic - Nagoya /ID# 211476
  - Toyoake-shi, Aichi, Japan, 470-1192
    - Duplicate_Fujita Health University Hospital /ID# 163234
- Chiba
  - Abiko-shi, Chiba, Japan, 270-1168
    - Tokatsu Tsujinaka Hospital /ID# 163352
  - Chiba-shi, Chiba, Japan, 260-8677
    - Duplicate_Chiba University Hospital /ID# 217533
  - Kashiwa-shi, Chiba, Japan, 277-8567
    - The Jikei University Kashiwa Hospital /ID# 200030
  - Kashiwa-shi, Chiba, Japan, 277-0871
    - Tsujinaka Hospital - Kashiwanoha /ID# 213848
  - Sakura-shi, Chiba, Japan, 285-8741
    - Toho University Sakura Medical Center /ID# 160099
- Fukuoka
  - Fukuoka-shi, Fukuoka, Japan, 814-0180
    - Fukuoka University Hospital /ID# 217793
  - Kurume-shi, Fukuoka, Japan, 830-0011
    - Kurume University Hospital /ID# 160106
- Hiroshima
  - Fukuyama-shi, Hiroshima, Japan, 720-8520
    - National Hospital Organization Fukuyama Medical Center /ID# 163577
  - Hiroshima-shi, Hiroshima, Japan, 734-8551
    - Hiroshima University Hospital /ID# 160109
- Hokkaido
  - Asahikawa-shi, Hokkaido, Japan, 078-8510
    - Duplicate_Asahikawa Medical University Hospital /ID# 162848
  - Sapporo, Hokkaido, Japan, 060-8543
    - Sapporo Medical University Hospital /ID# 163056
  - Sapporo-shi, Hokkaido, Japan, 004-0041
    - Sapporo Tokushukai Hospital /ID# 213492
  - Sapporo-shi, Hokkaido, Japan, 060-0033
    - Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 160096
- Hyogo
  - Nishinomiya-shi, Hyogo, Japan, 663-8014
    - Nishinomiya Municipal Central Hospital /ID# 210103
  - Nishinomiya-shi, Hyogo, Japan, 663-8501
    - Hyogo Medical University Hospital /ID# 160107
- Ibaraki
  - Higashiibaraki-gun, Ibaraki, Japan, 311-3193
    - NHO Mito Medical Center /ID# 160092
- Ishikawa
  - Kanazawa-shi, Ishikawa, Japan, 920-8641
    - Kanazawa University Hospital /ID# 202258
- Kanagawa
  - Kamakura-shi, Kanagawa, Japan, 247-0056
    - Gokeikai Ofuna Chuo Hospital /ID# 171066
  - Sagamihara-shi, Kanagawa, Japan, 252-0375
    - Kitasato University Hospital /ID# 171065
  - Yokohama shi, Kanagawa, Japan, 232-0024
    - Duplicate_Yokohama City University Medical Center /ID# 163907
  - Yokohama-shi, Kanagawa, Japan, 221-0855
    - Duplicate_Yokohama Municipal Citizen's Hospital /ID# 207161
- Mie
  - Tsu-shi, Mie, Japan, 514-8507
    - Mie University Hospital /ID# 203640
  - Yokkaichi-shi, Mie, Japan, 510-0016
    - Yokkaichi Hazu Medical Center /ID# 163764
- Miyagi
  - Sendai-shi, Miyagi, Japan, 9808574
    - Tohoku University Hospital /ID# 162847
  - Sendai-shi, Miyagi, Japan, 981-8563
    - Tohoku Rosai Hospital /ID# 163229
- Osaka
  - Osaka-shi, Osaka, Japan, 545-8586
    - Osaka Metropolitan University Hospital /ID# 160117
- Saitama
  - Kawagoe, Saitama, Japan, 350-8550
    - Saitama Medical Center /ID# 160093
  - Saitama-shi, Saitama, Japan, 336-0963
    - Tokitokai Tokito clinic /ID# 160110
- Shiga
  - Otsu, Shiga, Japan, 520-2192
    - Shiga University of Medical Science Hospital /ID# 164025
- Shizuoka
  - Hamamatsu-shi, Shizuoka, Japan, 431-3192
    - Hamamatsu University Hospital /ID# 205690
  - Sunto-gun, Shizuoka, Japan, 411-8611
    - NHO Shizuoka Medical Center /ID# 163057
- Tokyo
  - Bunkyo-ku, Tokyo, Japan, 113-8519
    - Institute of Science Tokyo Hospital /ID# 160095
  - Hachioji-shi, Tokyo, Japan, 192-0032
    - Tokai University Hachioji Hospital /ID# 160098
  - Minato-ku, Tokyo, Japan, 105-8471
    - The Jikei University Hospital /ID# 163209
  - Minato-ku, Tokyo, Japan, 108-8642
    - Kitasato University Kitasato Institute Hospital /ID# 160105
  - Mitaka-shi, Tokyo, Japan, 181-8611
    - Kyorin University Hospital /ID# 160114
  - Shinjuku-ku, Tokyo, Japan, 162-8666
    - Tokyo Women's Medical University Hospital /ID# 205974
- Wakayama
  - Wakayama-shi, Wakayama, Japan, 641-8510
    - Wakayama Medical University Hospital /ID# 202561
- Yamagata
  - Yamagata-shi, Yamagata, Japan, 990-9585
    - Yamagata University Hospital /ID# 200159
- Yamanashi
  - Kofu-shi, Yamanashi, Japan, 400-8506
    - Yamanashi Prefectural Central Hospital /ID# 160094
Korea, Republic of
- - Daegu, Korea, Republic of, 42415
    - Yeungnam University Medical Center /ID# 158691
  - Seoul, Korea, Republic of, 03722
    - Yonsei University Health System Severance Hospital /ID# 158689
- Busan Gwang Yeogsi
  - Busan, Busan Gwang Yeogsi, Korea, Republic of, 48108
    - Inje University Haeundae Hospital /ID# 202518
  - Busan, Busan Gwang Yeogsi, Korea, Republic of, 49241
    - Pusan National University Hospital /ID# 158695
  - Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
    - Dong-A University Medical Center /ID# 158699
- Daejeon Gwang Yeogsi
  - Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of, 34943
    - The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 213554
- Gyeonggido
  - Guri-si, Gyeonggido, Korea, Republic of, 11923
    - Hanyang University Guri Hospital /ID# 158690
  - Seongnam si, Gyeonggido, Korea, Republic of, 13496
    - Duplicate_CHA University Bundang Medical Center /ID# 158698
  - Suwon, Gyeonggido, Korea, Republic of, 16247
    - The Catholic University Of Korea St. Vincent's Hospital /ID# 158693
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
    - Kangbuk Samsung Hospital /ID# 158694
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
    - Asan Medical Center /ID# 158696
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
    - Samsung Medical Center /ID# 158692
Latvia
- - Riga, Latvia, 1035
    - VCA Polyclinic Aura /ID# 159611
  - Riga, Latvia, LV-1079
    - Duplicate_Digestive Disease Center Gastro /ID# 163107
  - Riga, Latvia, LV-1002
    - Pauls Stradins Clinical University Hospital /ID# 159612
Lithuania
- - Kaunas, Lithuania, 50161
    - Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162583
  - Vilnius, Lithuania, 08661
    - Vilnius University Hospital Santaros Klinikos /ID# 162514
Malaysia
- - Kelantan, Malaysia, 16150
    - Universiti Sains Malaysia /ID# 160666
- Sabah
  - Division Pantai Barat Utara, Sabah, Malaysia, 88200
    - Queen Elizabeth Hospital /ID# 160664
- Selangor
  - Kuala Lumpur, Selangor, Malaysia, 56000
    - Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201363
Mexico
- - Del. Benito Juárez, Mexico, 03810
    - Health Pharma Professional Research S.A de C.V /ID# 170730
- Jalisco
  - Zapopan, Jalisco, Mexico, 45070
    - Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170734
- Morelos
  - Cuernavaca, Morelos, Mexico, 62290
    - JM Research SC /ID# 170729
- Yucatan
  - Merida, Yucatan, Mexico, 97000
    - Unidad de Atencion Medica e Investigacion en Salud /ID# 170732
Netherlands
- Noord-Brabant
  - Tilburg, Noord-Brabant, Netherlands, 5022 GC
    - Elisabeth Tweesteden Ziekenhuis /ID# 163632
- Noord-Holland
  - Amsterdam, Noord-Holland, Netherlands, 1105 AZ
    - Amsterdam UMC, locatie AMC /ID# 157956
New Zealand
- - Otago, New Zealand, 9016
    - Dunedin Hospital /ID# 167227
  - Wellington, New Zealand, 6021
    - Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167225
- Auckland
  - Papatoetoe, Auckland, New Zealand, 2025
    - Aotearoa Clinical Trials /ID# 167226
- Canterbury
  - Christchurch, Canterbury, New Zealand, 8011
    - Christchurch Hospital. /ID# 167224
Norway
- Akershus
  - Gjettum, Akershus, Norway, 1346
    - Duplicate_Vestre viken - Baerum Sykehus /ID# 212996
  - Nordbyhagen, Akershus, Norway, 1474
    - Akershus Universitetssykehus /ID# 169379
- More Og Romsdal
  - Ålesund, More Og Romsdal, Norway, 6017
    - Helse More og Romsdal HF, Alesund sjukehus /ID# 212810
- Nord-Trondelag
  - Levanger, Nord-Trondelag, Norway, 7601
    - Sykehuset Levanger Helse NT /ID# 201669
Poland
- Dolnoslaskie
  - Wroclaw, Dolnoslaskie, Poland, 52-210
    - Planetmed Sp. z o.o. /ID# 202799
  - Wroclaw, Dolnoslaskie, Poland, 50-556
    - Duplicate_Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocl /ID# 212601
- Kujawsko-pomorskie
  - Torun, Kujawsko-pomorskie, Poland, 87-100
    - Gastromed Sp. z o.o /ID# 212476
- Lodzkie
  - Lodz, Lodzkie, Poland, 90-153
    - Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212477
- Lubelskie
  - Lublin, Lubelskie, Poland, 20-049
    - 1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 210940
  - Lublin, Lubelskie, Poland, 20-954
    - Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie /ID# 210941
- Mazowieckie
  - Warsaw, Mazowieckie, Poland, 04-730
    - Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213580
  - Warszawa, Mazowieckie, Poland, 00-189
    - Centrum Zdrowia MDM /ID# 163570
  - Warszawa, Mazowieckie, Poland, 02-507
    - Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 163582
  - Warszawa, Mazowieckie, Poland, 03-580
    - Vivamed Sp. z o.o. /ID# 202800
- Podkarpackie
  - Rzeszow, Podkarpackie, Poland, 35-055
    - Centrum Medycznym Medyk /ID# 212891
- Pomorskie
  - Chojnice, Pomorskie, Poland, 89-600
    - Centrum Medyczne Lukamed Sp. z o.o. /ID# 212478
- Slaskie
  - Tychy, Slaskie, Poland, 43-100
    - H-T Centrum Medyczne Endoterapia /ID# 212475
- Warminsko-mazurskie
  - Olsztyn, Warminsko-mazurskie, Poland, 10-561
    - Wojewódzki Szpital Specjalistyczny W Olsztynie /ID# 212474
- Wielkopolskie
  - Poznan, Wielkopolskie, Poland, 60-529
    - Solumed Centrum Medyczne /ID# 163569
Portugal
- - Faro, Portugal, 8000-386
    - Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160713
  - Lisboa, Portugal, 1349-019
    - Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167751
  - Lisboa, Portugal, 1649-035
    - Unidade Local de Saude de Santa Maria, EPE /ID# 160692
  - Lisbon, Portugal, 1169-050
    - Centro Hospitalar de Lisboa Central /ID# 160673
  - Loures, Portugal, 2674-514
    - Hospital de Loures, E.P.E /ID# 207759
  - Porto, Portugal, 4200-319
    - Unidade Local de Saude Sao Joao, EPE /ID# 160693
  - Viseu, Portugal, 3504-509
    - Centro Hosp de Tondela-Viseu /ID# 160699
- Braga
  - Guimaraes, Braga, Portugal, 4835-044
    - Duplicate_Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160737
- Faro
  - Portimão, Faro, Portugal, 8500-338
    - Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167752
- Porto
  - Santa Maria Da Feira, Porto, Portugal, 4520-211
    - Centro Hospitalar de Entre Douro e Vouga /ID# 160672
- Setubal
  - Almada, Setubal, Portugal, 2805-267
    - Duplicate_Hospital Garcia de Orta, EPE /ID# 160745
Romania
- - Bucharest, Romania, 022328
    - Fundeni Clinical Institute /ID# 170899
  - Cluj, Romania, 400132
    - Tvm Med Serv Srl /Id# 170902
  - Timisoara, Romania, 300168
    - Duplicate_Centrul Medical Tuculanu SRL /ID# 170903
  - Timișoara, Romania, 300002
    - Cabinet Particular Policlinic Algomed /ID# 170900
Russian Federation
- - Moscow, Russian Federation, 123423
    - National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204808
  - St. Petersburg, Russian Federation, 197110
    - City Clinical Hospital No. 31 /ID# 208872
  - Ulyanovsk, Russian Federation, 432017
    - Ulyanovsk Regional Clinical Hospital /ID# 200964
- Kemerovskaya Oblast
  - Kemerovo, Kemerovskaya Oblast, Russian Federation, 650099
    - Kuzbass Regional Clinical Hospital /ID# 200962
- Novosibirskaya Oblast
  - Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630007
    - Novosibirski Gastrocenter /ID# 217552
- Permskiy Kray
  - Perm, Permskiy Kray, Russian Federation, 614990
    - Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207439
- Sankt-Peterburg
  - Saint Petersburg, Sankt-Peterburg, Russian Federation, 194100
    - Duplicate_St. Petersburg State Pediatric Medical University /ID# 211978
- Stavropol Skiy Kray
  - Stavropol, Stavropol Skiy Kray, Russian Federation, 355012
    - Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200970
- Tverskaya Oblast
  - Tver, Tverskaya Oblast, Russian Federation, 170036
    - Tver Regional Clinical Hospital /ID# 206858
- Tyumenskaya Oblast
  - Tyumen, Tyumenskaya Oblast, Russian Federation, 625023
    - Regional Clinical Hospital #1 /ID# 200973
- Udmurtskaya Respublika
  - Izhevsk, Udmurtskaya Respublika, Russian Federation, 426061
    - Alliance Biomedical Ural Group /ID# 200972
Serbia
- - Novi Sad, Serbia, 21000
    - University Clinical Center Vojvodina /ID# 157046
- Beograd
  - Belgrade, Beograd, Serbia, 11000
    - Clinical Hosp Center Zvezdara /ID# 157052
  - Belgrade, Beograd, Serbia, 11000
    - Military Medical Academy /ID# 157053
  - Belgrade, Beograd, Serbia, 11000
    - University Clinical Center Serbia /ID# 157047
  - Belgrade, Beograd, Serbia, 11080
    - Clin Hosp Ctr Bezanijska Kosa /ID# 157050
  - Belgrade, Beograd, Serbia, 11000
    - University Children's Hospital 'Tirsova' /ID# 211482
  - Belgrade, Beograd, Serbia, 11040
    - Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212799
- Jablanicki Okrug
  - Leskovac, Jablanicki Okrug, Serbia, 16000
    - General Hospital Leskovac /ID# 209575
- Sumadijski Okrug
  - Kragujevac, Sumadijski Okrug, Serbia, 34000
    - Duplicate_University Clinical Center Kragujevac /ID# 157049
Singapore
- - Singapore, Singapore, 119074
    - National University Hospital /ID# 160667
  - Singapore, Singapore, 169608
    - Singapore General Hospital /ID# 160668
- Central Singapore
  - Singapore, Central Singapore, Singapore, 228510
    - Mount Elizabeth Hospital /ID# 205741
Slovakia
- Banskobystricky Kraj
  - Banska Bystrica, Banskobystricky Kraj, Slovakia, 975 17
    - Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156468
- Nitriansky Kraj
  - Nitra, Nitriansky Kraj, Slovakia, 949 01
    - KM Management, spol. s.r.o. /ID# 206764
- Presovsky Kraj
  - Prešov, Presovsky Kraj, Slovakia, 080 01
    - Gastro I., s.r.o. /ID# 156469
South Africa
- Gauteng
  - Johannesburg, Gauteng, South Africa, 1619
    - Clinresco Centers /ID# 163865
  - Johannesburg, Gauteng, South Africa, 1864
    - Wits Clinical Research /ID# 158114
- Western Cape
  - CAPE TOWN Milnerton, Western Cape, South Africa, 7441
    - Spoke Research Inc /ID# 158116
  - Cape Town, Western Cape, South Africa, 7800
    - Private Practice Dr MN Rajabally /ID# 163112
Spain
- - Barcelona, Spain, 08036
    - Hospital Clinic de Barcelona /ID# 157552
  - Madrid, Spain, 28007
    - Hospital General Universitario Gregorio Maranon /ID# 161145
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz /ID# 159235
  - Salamanca, Spain, 37711
    - Hospital Universitario de Salamanca /ID# 157558
  - Sevilla, Spain, 41009
    - Hospital Universitario Virgen Macarena /ID# 159967
  - Valencia, Spain, 46010
    - Hospital Clinico Universitario de Valencia /ID# 209700
  - Valencia, Spain, 46026
    - Hospital Universitario y Politecnico La Fe /ID# 157556
  - Zaragoza, Spain, 50009
    - Hospital Clinico Universitario Lozano Blesa /ID# 212525
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet /ID# 157557
- A Coruna
  - Ferrol, A Coruna, Spain, 15405
    - Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157553
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Hospital Universitari de Bellvitge /ID# 208207
  - Sabadell, Barcelona, Spain, 08208
    - Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159237
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro - Majadahonda /ID# 157573
- Vizcaya
  - Bilbao, Vizcaya, Spain, 48013
    - Hospital Universitario Basurto /ID# 205190
Sweden
- Skane Lan
  - Malmo, Skane Lan, Sweden, 214 28
    - Skane University hospital /ID# 211745
- Stockholms Lan
  - Solna, Stockholms Lan, Sweden, 171 64
    - Karolinska University Hospital Solna /ID# 212025
  - Stockholm, Stockholms Lan, Sweden, 114 28
    - GHP Stockholm Gastro Center /ID# 211748
  - Stockholm, Stockholms Lan, Sweden, 182 88
    - Danderyd Hospital /ID# 202138
  - Stockholm, Stockholms Lan, Sweden, 116 28
    - Medicinkliniken, Gastroenheten /ID# 163744
- Vastra Gotalands Lan
  - Gothenburg, Vastra Gotalands Lan, Sweden, 413 45
    - Duplicate_Sahlgrenska University Hospital /ID# 163792
  - Gothenburg, Vastra Gotalands Lan, Sweden, 413 46
    - Duplicate_Sahlgrenska University Hospital /ID# 163797
Switzerland
- - Bern, Switzerland, 3010
    - Inselspital, Universitaetsspital Bern /ID# 163535
- Basel-Stadt
  - Basel Town, Basel-Stadt, Switzerland, 4031
    - University Hospital Basel /ID# 164554
- Zuerich
  - Zurich, Zuerich, Switzerland, 8006
    - University Hospital Zurich /ID# 163536
Taiwan
- - Taichung, Taiwan, 40705
    - Taichung Veterans General Hospital /ID# 160140
  - Taichung, Taiwan, 40447
    - China Medical University Hospital /ID# 160141
  - Tainan, Taiwan, 704
    - National Cheng Kung University Hospital /ID# 160142
  - Taipei, Taiwan, 11217
    - Taipei Veterans General Hosp /ID# 212712
- Taipei
  - Taipei City, Taipei, Taiwan, 100
    - National Taiwan University Hospital /ID# 162190
Ukraine
- - Kharkiv, Ukraine, 61037
    - Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 165657
  - Kherson, Ukraine, 73000
    - Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 212399
  - Kyiv, Ukraine, 02232
    - Communal Noncommercial Institution Consultative and Diagnostic Center of Desnian /ID# 165659
  - Kyiv, Ukraine, 03037
    - Medical Center of LLC Medbud-Clinic /ID# 216998
  - Kyiv, Ukraine, 03049
    - Kyiv Railway Clinical Hosp No.2 /ID# 217366
  - Kyiv, Ukraine, 01030
    - Kyiv City Clinical Hospital No.18 /ID# 162531
  - Kyiv, Ukraine, 02091
    - Medical Center OK Clinic LLC, International Institute of Clinical Research /ID# 211998
- Lvivska Oblast
  - Lviv, Lvivska Oblast, Ukraine, 79000
    - Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 165658
- Vinnytska Oblast
  - Vinnytsia, Vinnytska Oblast, Ukraine, 21018
    - MNE Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216474
  - Vinnytsia, Vinnytska Oblast, Ukraine, 21029
    - University Hospital of M.I. Pyrogov VNMU /ID# 212000
- Volynska Oblast
  - Lutsk, Volynska Oblast, Ukraine, 43005
    - ME Volyn Regional Clinical Hospital of Volyn Regional Council /ID# 206789
- Zakarpatska Oblast
  - Uzhgorod, Zakarpatska Oblast, Ukraine, 88018
    - Transcarpathian Regional Clinical Hospital n.a. Andriy Novak /ID# 167960
United Kingdom
- - Barnsley, United Kingdom, S75 2EP
    - Barnsley Hospital NHS Foundation Trust /ID# 202773
  - Birmingham, United Kingdom, B15 2TH
    - University Hospitals Birmingham NHS Foundation Trust /ID# 157545
  - Huddersfield, United Kingdom, HX3 0PW
    - Calderdale and Huddersfield NHS Foundation Trust /ID# 209570
  - London, United Kingdom, SE5 9RS
    - King's College Hospital NHS Foundation Trust /ID# 158760
  - Newcastle upon Tyne, United Kingdom, NE3 3HD
    - The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163708
  - Salford, United Kingdom, M6 8HD
    - Northern Care Alliance NHS Group /ID# 207766
- Cambridgeshire
  - Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
    - Addenbrooke's Hospital /ID# 158034
- Devon
  - Exeter, Devon, United Kingdom, EX2 5DW
    - Duplicate_Royal Devon University Healthcare NHS Foundation Trust /ID# 157544
- East Riding Of Yorkshire
  - Hull, East Riding Of Yorkshire, United Kingdom, HU3 2JZ
    - Hull University Teaching Hospitals NHS Trust /ID# 158761
- Edinburgh, City Of
  - Edinburgh, Edinburgh, City Of, United Kingdom, EH4 2XU
    - Western General Hospital - NHS Lothian /ID# 207448
- Glasgow City
  - Glasgow, Glasgow City, United Kingdom, G12 0YN
    - Gartnavel General Hospital /ID# 202568
- Greater London
  - London, Greater London, United Kingdom, E1 2ES
    - Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 163713
  - London, Greater London, United Kingdom, SE1 9RT
    - Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 157546
- Oxfordshire
  - Oxford, Oxfordshire, United Kingdom, OX3 9DU
    - Oxford University Hospitals NHS Foundation Trust /ID# 158036
- Surrey
  - Chertsey, Surrey, United Kingdom, KT16 0PZ
    - Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207936
- West Yorkshire
  - Leeds, West Yorkshire, United Kingdom, LS9 7TF
    - Leeds Teaching Hospitals NHS Trust /ID# 157550
United States
- Arizona
  - Mesa, Arizona, United States, 85206
    - Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884
  - Phoenix, Arizona, United States, 85012
    - Phoenix VA Health Care System /ID# 162264
  - Tucson, Arizona, United States, 85719
    - Banner - University Medical Center Tucson /ID# 158502
- Arkansas
  - Little Rock, Arkansas, United States, 72209-7040
    - Atria Clinical Research /ID# 164505
- California
  - Coronado, California, United States, 92118-1408
    - Southern California Res. Ctr. /ID# 211991
  - Huntington Beach, California, United States, 92648
    - Duplicate_Newport Huntington Medical Group /ID# 213035
  - La Jolla, California, United States, 92093
    - UC San Diego Health Systems /ID# 155555
  - Los Alamitos, California, United States, 90720-3309
    - United Medical Doctors /ID# 207888
  - Los Angeles, California, United States, 90048
    - TLC Clinical Research Inc /ID# 212719
  - Los Angeles, California, United States, 90067-2001
    - Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162657
  - Murrieta, California, United States, 92563
    - United Medical Doctors - Murrieta /ID# 158300
  - San Francisco, California, United States, 94158
    - University of California San Francisco - Mission Bay /ID# 157127
  - West Hollywood, California, United States, 90048
    - Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 163839
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Peak Gastroenterology Associates, PC /ID# 165843
  - Lone Tree, Colorado, United States, 80124-6798
    - Rocky Mountain Pediatric Gastroenterology /ID# 207170
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Duplicate_Western Connecticut Medical Group /ID# 165879
- Florida
  - Brandon, Florida, United States, 33510-3107
    - Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 162262
  - Clermont, Florida, United States, 34711
    - South Lake Pain Institute, Inc /ID# 162808
  - DeBary, Florida, United States, 32713-2260
    - Omega Research Maitland, LLC /ID# 171082
  - Doral, Florida, United States, 33166
    - Universal Axon Clinical Research /ID# 165428
  - Inverness, Florida, United States, 34452-4717
    - Nature Coast Clinical Research - Inverness /ID# 159408
  - Kissimmee, Florida, United States, 34741-4161
    - SIH Research Mumtaz, Inc /ID# 163083
  - Lighthouse Point, Florida, United States, 33064
    - Alliance Medical Research /ID# 163837
  - Maitland, Florida, United States, 32751-6108
    - Cfagi Llc /Id# 202479
  - Miami, Florida, United States, 33136-1002
    - Sylvester Comprehensive Cancer Center /ID# 155007
  - Miami, Florida, United States, 33186-4643
    - Coral Research Clinic /ID# 158456
  - Miami, Florida, United States, 33193
    - South Florida Research Ph I-IV, Inc. /ID# 161832
  - Naples, Florida, United States, 34102
    - Gastroenterology Group Naples /ID# 165204
  - New Port Richey, Florida, United States, 34653
    - Advanced Research Institute, Inc /ID# 161966
  - Orlando, Florida, United States, 32803
    - Endoscopic Research, Inc. /ID# 205906
  - Palmetto Bay, Florida, United States, 33157
    - IMIC Inc. Medical Research /ID# 154942
  - Tampa, Florida, United States, 33606-1246
    - Duplicate_Clinical Research of West Florida, Inc /ID# 208125
  - Tampa, Florida, United States, 33606
    - Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 205865
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastro Assoc /ID# 154724
  - Macon, Georgia, United States, 31201
    - Gastroenterology Associates of Central Georgia, LLC /ID# 154850
- Illinois
  - Chicago, Illinois, United States, 60637-1443
    - The University of Chicago Medical Center /ID# 157124
  - Chicago, Illinois, United States, 60611-2927
    - Duplicate_Northwestern University /ID# 158261
  - Evanston, Illinois, United States, 60201
    - NorthShore University-Endeavor Health Evanston Hospital /ID# 158265
  - Oak Lawn, Illinois, United States, 60453
    - Southwest Gastroenterology /ID# 164781
- Kansas
  - Topeka, Kansas, United States, 66606
    - Cotton O'Neil Clinical Research Center, Digestive Health /ID# 154722
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - Duplicate_University of Kentucky Chandler Medical Center /ID# 157120
  - Louisville, Kentucky, United States, 40202
    - University of Louisville Hospital /ID# 210525
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - GI Alliance /ID# 161963
  - Houma, Louisiana, United States, 70360
    - Houma Digestive Health Special /ID# 158264
  - New Orleans, Louisiana, United States, 70115
    - Delricht Research /ID# 206644
  - New Orleans, Louisiana, United States, 70115
    - Nola Research Works, LLC /ID# 161317
  - Shreveport, Louisiana, United States, 71105-6800
    - Louisiana Research Center, LLC /ID# 162237
- Maryland
  - Chevy Chase, Maryland, United States, 20815
    - Metropolitan Gastroenterology Group - Chevy Chase /ID# 154832
  - Columbia, Maryland, United States, 21045
    - Gastro Center of Maryland /ID# 165001
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 157126
  - Chesterfield, Michigan, United States, 48047
    - Clin Res Inst of Michigan, LLC /ID# 169179
  - Troy, Michigan, United States, 48098-6363
    - Center for Digestive Health /ID# 154683
  - Wyoming, Michigan, United States, 49519
    - Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161313
- Minnesota
  - Rochester, Minnesota, United States, 55905-0001
    - Mayo Clinic - Rochester /ID# 163086
- Missouri
  - Saint Louis, Missouri, United States, 63104
    - St. Louis University /ID# 161883
- Nebraska
  - Omaha, Nebraska, United States, 68198-2000
    - University of Nebraska Medical Center /ID# 210058
- Nevada
  - Las Vegas, Nevada, United States, 89128-3157
    - Revival Research Institute, Inc /ID# 210985
  - Las Vegas, Nevada, United States, 89128-0435
    - Vector Clinical Trials /ID# 160170
- New York
  - Brooklyn, New York, United States, 11235
    - NY Scientific /ID# 158294
  - Burnt Hills, New York, United States, 12027
    - Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213447
  - Fresh Meadows, New York, United States, 11366
    - Intercity Advanced Gastroentertology Center /ID# 215205
  - Great Neck, New York, United States, 11021-5206
    - Duplicate_Northwell Health Division of Gastroenterology at Great Neck /ID# 168738
  - Lake Success, New York, United States, 11042
    - NYU Langone Long Island Clinical Research Associates /ID# 154829
  - New Hyde Park, New York, United States, 11040
    - Digestive Disease Care /ID# 211777
  - New York, New York, United States, 10016-6402
    - NYU Langone Medical Center /ID# 160169
  - New York, New York, United States, 10022
    - Weill Cornell Medicine /ID# 165878
  - New York, New York, United States, 10032-3725
    - Columbia Univ Medical Center /ID# 161899
  - New York, New York, United States, 10075
    - Lenox Hill Hospital /ID# 168467
  - New York, New York, United States, 10029
    - Icahn School of Medicine at Mount Sinai /ID# 165612
  - North Massapequa, New York, United States, 11758
    - Duplicate_DiGiovanna Institute for Medical Education & Research /ID# 171126
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514-4220
    - Univ NC Chapel Hill /ID# 154833
  - Charlotte, North Carolina, United States, 28203
    - Atrium Health Carolinas Medical Center /ID# 158428
  - Raleigh, North Carolina, United States, 27612
    - Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154873
- North Dakota
  - Fargo, North Dakota, United States, 58104-5925
    - Plains Clinical Research Center, LLC /ID# 169718
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Tri-State Endoscopy Center /ID# 154927
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Main Campus /ID# 209226
  - Columbus, Ohio, United States, 43210
    - The Ohio State University /ID# 164708
  - Columbus, Ohio, United States, 43235
    - Optimed Research, Ltd. /ID# 167887
  - Dayton, Ohio, United States, 45424
    - Hometown Urgent Care and Resea /ID# 170464
  - Mentor, Ohio, United States, 44060-6211
    - Great Lakes Gastroenterology Research, LLC /ID# 201770
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73102
    - Hightower Clinical /ID# 211993
  - Oklahoma City, Oklahoma, United States, 73112
    - Digestive Disease Specialists /ID# 170775
  - Tulsa, Oklahoma, United States, 74136-7823
    - Adult Gastroenterology Associates - Gen 1 Research /ID# 208864
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15224-1334
    - Children's Hospital of Pittsburgh of UPMC /ID# 212544
  - Wyomissing, Pennsylvania, United States, 19610
    - Digestive Disease Associates, LTD - Wyomissing /ID# 208297
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina /ID# 212858
  - Greenville, South Carolina, United States, 29607
    - Gastroenterology Associates, P.A. of Greenville /ID# 154904
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Medical Center - GI Research /ID# 163838
- Tennessee
  - Cordova, Tennessee, United States, 38018
    - Gastro One /ID# 154726
  - Johnson City, Tennessee, United States, 37604
    - East Tennessee Research Institute /ID# 168739
  - Memphis, Tennessee, United States, 38119
    - Clinical Neuroscience Solutions - Memphis /ID# 164180
  - Nashville, Tennessee, United States, 37232-0011
    - Vanderbilt University Medical Center /ID# 157121
- Texas
  - Arlington, Texas, United States, 76012
    - TX Clinical Research Institute /ID# 159404
  - Baytown, Texas, United States, 77521-2415
    - Inquest Clinical Research /ID# 165694
  - Cedar Park, Texas, United States, 78613-5028
    - Texas Digestive Disease Consultants /ID# 209946
  - Cedar Park, Texas, United States, 78613
    - GI Alliance /ID# 209797
  - Dallas, Texas, United States, 75246
    - Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 159406
  - Garland, Texas, United States, 75044-2208
    - Duplicate_DHAT Research Institute /ID# 158208
  - Houston, Texas, United States, 77017-2337
    - Vilo Research Group Inc /ID# 207655
  - Houston, Texas, United States, 77058
    - Centex Studies, Inc. - Houston /ID# 201219
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine /ID# 158203
  - San Antonio, Texas, United States, 78212
    - Clinical Associates in Research Therapeutics of America, LLC /ID# 161323
  - San Antonio, Texas, United States, 78229-5390
    - Southern Star Research Institute, LLC /ID# 168773
  - Temple, Texas, United States, 76508
    - Baylor Scott & White Center for Diagnostic Medicine /ID# 204131
  - Tyler, Texas, United States, 75701
    - Tyler Research Institute, LLC /ID# 166797
  - Victoria, Texas, United States, 77904
    - Gastro Health & Nutrition - Victoria /ID# 164290
- Utah
  - Ogden, Utah, United States, 84405
    - Advanced Research Institute /ID# 154907
  - West Jordan, Utah, United States, 84088
    - Velocity Clinical Research - Salt Lake City /ID# 161778
- Virginia
  - Richmond, Virginia, United States, 23249
    - Richmond VA Medical Center /ID# 159988
- Washington
  - Seattle, Washington, United States, 98101
    - Duplicate_Virginia Mason Medical Center /ID# 155556
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Hospitals /ID# 167941

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Participants who have entered and completed Study M16-006 or Study M15-991 or other AbbVie risankizumab Crohn's disease study.
Participants have completed the study M16-006 or M15-991 and have achieved clinical response.
Sub-Study 4:
- Participants receiving maintenance treatment in Sub-study 3 and willing to comply with the requirements of Sub-study 4, including self-administration of sub-cutaneous injections using the on-body injector (OBI).
- Participant has received at least 16 weeks of stable dosing with risankizumab in Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the 72-week mark).

Exclusion Criteria:

Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter Study M16-000 OR is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an adverse event (AE) during Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study that in the Investigator's judgment makes the participant unsuitable for this study.
Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study.
Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study.
Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Double-blind Placebo for Risankizumab (Sub-Study 1) Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.	Drug: Placebo for Risankizumab SC Placebo for Risankizumab SC Subcutaneous (SC) Injection
Experimental: Double-blind Risankizumab Dose 1 (Sub-Study 1) Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.	Drug: Risankizumab SC Risankizumab SC Subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI
Experimental: Double-blind Risankizumab Dose 2 (Sub-Study 1) Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.	Drug: Risankizumab SC Risankizumab SC Subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI
Experimental: Maintenance Risankizumab Dose 1 (Sub-Study 2) Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.	Drug: Risankizumab SC Risankizumab SC Subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI Drug: Placebo for Risankizumab IV Placebo for Risankizumab IV Intravenous (IV) infusion
Experimental: Maintenance Risankizumab Dose 2 (Sub-Study 2) Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.	Drug: Placebo for Risankizumab SC Placebo for Risankizumab SC Subcutaneous (SC) Injection Drug: Risankizumab SC Risankizumab SC Subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI Drug: Risankizumab IV Risankizumab IV Intravenous (IV) infusion Other Names: BI 655066 ABBV-066 SKYRIZI
Experimental: Open-label Risankizumab (Sub-Study 3) Participants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.	Drug: Risankizumab SC Risankizumab SC Subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI
Experimental: Risankizumab On-Body Injector and Open Label (Sub-Study 4) Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.	Drug: Risankizumab SC Risankizumab SC Subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI Drug: Risankizumab On-Body Injector (OBI) Subcutaneous (SC) injection; on-body injector (OBI) Other Names: BI 655066 ABBV-066 SKYRIZI
Experimental: CTE: Open Label Continuous Treatment Extension Participants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.	Drug: Risankizumab SC Risankizumab SC Subcutaneous (SC) injection Other Names: BI 655066 ABBV-066 SKYRIZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission Time Frame: Week 52	The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150.	Week 52
Sub-Study 1: Percentage of Participants With Endoscopic Response Time Frame: Week 52	Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).	Week 52
Sub-Study 3: Number of Participants With Adverse Events Time Frame: Up to Week 220	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.	Up to Week 220
Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration Time Frame: Up to Week 16	Participant who successfully completed the sequence of critical steps in the instructions for use (IFU) without errors to administer study drug via the OBI at Week 0 and 16.	Up to Week 16
Sub-Study 4: Percentage of Participants who had no Potential Hazards Time Frame: Up to Week 16	Measured by an observer on the possible use-related hazards checklist for self-administration with OBI at Week 0 and Week 16.	Up to Week 16
Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16 Time Frame: Up to Week 16	SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed 20 to 40 min following injections at Weeks 0, 8, 16. These modules are completed by participants while alone in a quiet environment. Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules.	Up to Week 16
Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16 Time Frame: Up to Week 16	Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.	Up to Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sub-Study 1: Percentage of Participants With Clinical Remission Time Frame: Week 52	Clinical remission per average daily stool frequency (SF) and average daily AP score.	Week 52
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0 Time Frame: Week 52	The CDAI is used to evaluate disease activity in patients with Crohn's disease	Week 52
Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy Time Frame: Week 52	Endoscopic healing was assessed using SES-CD.	Week 52
Sub-Study 1: Percentage of Participants With Endoscopic Remission Time Frame: Week 52	Endoscopic Remission is defined as SES-CD <= 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer	Week 52
Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Time Frame: Week 52	The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.	Week 52
Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline Time Frame: Week 52	Participants who discontinued corticosteroid use and achieved clinical remission per average daily SF and average daily AP score.	Week 52
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response Time Frame: Week 52	The CDAI is used to evaluate disease activity in patients with Crohn's disease.	Week 52
Sub-Study 1: Percentage of Participants With Stool Frequency (SF) Remission Time Frame: Week 52	SF Remission is defined by an average daily SF <= 2.8 and not worse than baseline.	Week 52
Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission Time Frame: Week 52	AP Remission is defined by an average daily AP <= 1 and not worse than baseline.	Week 52
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response Time Frame: Week 52	The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150. Endoscopic response defined as decrease from baseline of > 50% of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).	Week 52
Sub-Study 1: Percentage of Participants With Deep Remission Time Frame: Week 52	Deep remission defined as participants with both clinical remission (per average daily SF and average daily AP score) and endoscopic remission (assessed using SES-CD).	Week 52
Sub-Study 1: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52 Time Frame: Up to Week 52	Participants with an event that results in admission to the hospital.	Up to Week 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sub-Study 2: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission Time Frame: Week 52	The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150.	Week 52
Sub-Study 2: Percentage of Participants With Endoscopic Response Time Frame: Week 52	Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).	Week 52
Sub-Study 2: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52 Time Frame: Up to Week 52	Participants with an event that results in admission to the hospital.	Up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Ferrante M, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, D'Haens G. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022 May 28;399(10340):2031-2046. doi: 10.1016/S0140-6736(22)00466-4.

Helpful Links

This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2018

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M16-000
2023-506399-28-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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United States, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Ireland, Israel, Italy, Korea, Republic... and more
Merida Biosciences

Recruiting

NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease

Graves Disease

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AbbVie

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Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis (UnlIMMited)

Scalp Psoriasis | Genital Psoriasis

United States
AbbVie
Boehringer Ingelheim

Completed

Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.

Crohn Disease
AbbVie

Completed

Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation (IMMPRESS)

Psoriasis

Russian Federation
MoonLake Immunotherapeutics AG

Recruiting

Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response (IZAR-2)

Arthritis, Psoriatic

Bulgaria, United States, Hungary, Poland, Germany, France, Spain, Canada, Czechia, Georgia, United Kingdom
AbbVie

Completed

Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement (IMMprint)

Psoriasis

United States, Canada, Puerto Rico, Spain

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease (FORTIFY)

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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