Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease (Target CD)

June 1, 2026 updated by: AbbVie

A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.

The medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 540 participants will be enrolled in the study at approximately 300 sites worldwide.

Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein.

There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.

Study Overview

Status

Recruiting

Conditions

Crohn's Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

540

Phase

Phase 2

Contacts and Locations

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

Study Contact

Name: ABBVIE CALL CENTER
Phone Number: 844-663-3742
Email: abbvieclinicaltrials@abbvie.com

Study Locations

Austria
- - Salzburg, Austria, 5020
    - Recruiting
    - Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 265928
  - Vienna, Austria, 1090
    - Recruiting
    - Medizinische Universitaet Wien /ID# 265926
- Styria
  - Graz, Styria, Austria, 8010
    - Recruiting
    - Medizinische Universitaet Graz /ID# 275453
- Tyrol
  - Innsbruck, Tyrol, Austria, 6020
    - Recruiting
    - Medizinische Universitaet Innsbruck /ID# 265930
- Upper Austria
  - Linz, Upper Austria, Austria, 4010
    - Recruiting
    - Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 265929
  - Wels, Upper Austria, Austria, 4600
    - Completed
    - Klinikum Wels-Grieskirchen GmbH /ID# 266035
Belgium
- - Liège, Belgium, 4000
    - Recruiting
    - CHU de Liege /ID# 265542
- Antwerpen
  - Bonheiden, Antwerpen, Belgium, 2820
    - Recruiting
    - Imelda Ziekenhuis /ID# 265995
- Brussels Capital
  - Anderlecht, Brussels Capital, Belgium, 1070
    - Recruiting
    - Universite Libre de Bruxelles - Hopital Erasme /ID# 265993
  - Brussels, Brussels Capital, Belgium, 1000
    - Recruiting
    - CHU Saint-Pierre /ID# 266431
    - Contact:
      
      Site Coordinator
      
      Phone Number: +32 2 535 46 03
  - Brussels, Brussels Capital, Belgium, 1200
    - Recruiting
    - Cliniques Universitaires UCL Saint-Luc /ID# 265521
- Liege
  - Liège, Liege, Belgium, 4000
    - Recruiting
    - Groupe Sante CHC - Clinique du MontLegia /ID# 265522
- Namur
  - Yvoir, Namur, Belgium, 5530
    - Recruiting
    - Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 265517
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - Recruiting
    - Universitair Ziekenhuis Leuven /ID# 265519
- West-Vlaanderen
  - Kortrijk, West-Vlaanderen, Belgium, 8500
    - Recruiting
    - AZ Groeninge /ID# 265544
  - Ostend, West-Vlaanderen, Belgium, 8400
    - Recruiting
    - AZ Oostende /ID# 275534
Bulgaria
- - Plovdiv, Bulgaria, 4001
    - Recruiting
    - Umbal Kaspela /ID# 266234
  - Sofia, Bulgaria, 1407
    - Recruiting
    - Acibadem City Clinic Tokuda University Hospital EAD /ID# 267437
  - Sofia, Bulgaria, 1233
    - Recruiting
    - MHAT Knyaginya Klementina /ID# 266238
  - Sofia, Bulgaria, 1606
    - Completed
    - Military Medical Academy Multiprofile Hospital /ID# 267051
  - Varna, Bulgaria, 9009
    - Completed
    - UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 266237
- Sofia
  - Sofiya, Sofia, Bulgaria, 1527
    - Recruiting
    - Hospital Tsaritsa Yoanna /ID# 266235
  - Sofiya, Sofia, Bulgaria, 1632
    - Recruiting
    - Medical Center - Doverie /ID# 267050
  - Sofiya, Sofia, Bulgaria, 1784
    - Recruiting
    - ACIBADEM City Clinic Diagnostic-Consultative Center /ID# 266239
Canada
- - Québec, Canada, G1V 4T3
    - Recruiting
    - Diex Recherche Quebec Inc. /ID# 265611
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - Recruiting
    - University of Calgary /ID# 265524
  - Edmonton, Alberta, Canada, T6G 2B7
    - Recruiting
    - University of Alberta Hospital /ID# 265614
  - Edmonton, Alberta, Canada, T5R 1W2
    - Completed
    - Gastroenterology and Internal Medicine Research Institute /ID# 265610
- Ontario
  - Greater Sudbury, Ontario, Canada, P3C 1X3
    - Recruiting
    - Medicor Research /ID# 267405
  - London, Ontario, Canada, N6A 5A5
    - Recruiting
    - London Health Sciences Centre - University Hospital /ID# 267298
  - Vaughan, Ontario, Canada, L4L 4Y7
    - Recruiting
    - Toronto Digestive Disease Associates /ID# 267358
- Quebec
  - Montreal, Quebec, Canada, H3H 1E8
    - Recruiting
    - Clinique IMD /ID# 272057
Croatia
- City of Zagreb
  - Grad Zagreb, City of Zagreb, Croatia, 10000
    - Recruiting
    - Klinicki Bolnicki Centar Zagreb /ID# 265502
  - Zagreb, City of Zagreb, Croatia, 10000
    - Recruiting
    - Poliklinika Solmed /ID# 265509
- County of Osijek-Baranja
  - Osijek, County of Osijek-Baranja, Croatia, 31000
    - Recruiting
    - Poliklinika Borzan d.o.o. /ID# 265503
- Primorje-Gorski Kotar County
  - Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
    - Recruiting
    - Specialty Hospital Medico /ID# 265504
- Split-Dalmatia County
  - Split, Split-Dalmatia County, Croatia, 21000
    - Recruiting
    - Klinicki Bolnicki Centar (KBC) Split /ID# 265511
Czechia
- Hradec Kralove
  - Hradec Králové, Hradec Kralove, Czechia, 500 12
    - Recruiting
    - Hepato-Gastroenterologie HK /ID# 265387
- Praha 9
  - Prague, Praha 9, Czechia, 190 00
    - Completed
    - Iscare Klinické Centrum /ID# 265407
- South Moravian
  - Brno, South Moravian, Czechia, 602 00
    - Recruiting
    - SurGal Clinic /ID# 265388
Denmark
- Central Jutland
  - Aarhus, Central Jutland, Denmark, 8200
    - Recruiting
    - Aarhus Universitetshospital - Skejby /ID# 269064
- Region Syddanmark
  - Odense, Region Syddanmark, Denmark, 5000
    - Recruiting
    - Odense University Hospital /ID# 267778
Estonia
- - Tallinn, Estonia, 10138
    - Recruiting
    - East Tallinn Central Hospital /ID# 267658
  - Tartu, Estonia, 50406
    - Recruiting
    - Tartu University Hospital /ID# 267656
- Harju
  - Tallinn, Harju, Estonia, 13619
    - Recruiting
    - Medicum /ID# 268304
Finland
- Pirkanmaa
  - Tampere, Pirkanmaa, Finland, 33520
    - Recruiting
    - Tampere University Hospital /ID# 267721
- Southwest Finland
  - Turku, Southwest Finland, Finland, 20520
    - Recruiting
    - Turku University Hospital /ID# 267723
France
- - Nantes, France, 44314
    - Recruiting
    - Clinique Jules Verne /ID# 267480
  - Paris, France, 75012
    - Recruiting
    - Hopital Saint Antoine /ID# 265725
- Alpes-Maritimes
  - Nice, Alpes-Maritimes, France, 06202
    - Recruiting
    - Chu de Nice-Hopital Larchet Ii /Id# 267478
- Herault
  - Montpellier, Herault, France, 34295
    - Recruiting
    - CHU de Montpellier - Hopital Saint Eloi /ID# 265718
- Ille-et-Vilaine
  - Rennes, Ille-et-Vilaine, France, 35033
    - Recruiting
    - Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou /ID# 266848
- Meurthe-et-Moselle
  - Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
    - Recruiting
    - Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 265703
- New Aquitaine
  - Pessac, New Aquitaine, France, 33604
    - Completed
    - Centre Hospitalier Universitaire de Bordeaux /ID# 265721
- Occitanie
  - Toulouse, Occitanie, France, 31059
    - Recruiting
    - CHU de Toulouse - Hopital Rangueil /ID# 267479
- Pays de la Loire Region
  - St-Priest-en-Jarez, Pays de la Loire Region, France, 42270
    - Recruiting
    - Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 265340
- Rhone
  - Pierre-Bénite, Rhone, France, 69310
    - Recruiting
    - Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 266851
Germany
- - Berlin, Germany, 14050
    - Recruiting
    - DRK Kliniken Berlin - Westend /ID# 265925
  - Berlin, Germany, 14163
    - Recruiting
    - Krankenhaus Waldfriede /ID# 266676
    - Contact:
      
      Site Coordinator
      
      Phone Number: +49 30 818100
  - Berlin, Germany, 10117
    - Recruiting
    - Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 265752
- Baden-Wurttemberg
  - Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
    - Recruiting
    - Universitaetsklinikum Freiburg /ID# 265755
  - Mannheim, Baden-Wurttemberg, Germany, 68167
    - Recruiting
    - Universitaetsmedizin Mannheim /ID# 266961
  - Ulm, Baden-Wurttemberg, Germany, 89081
    - Recruiting
    - Universitaetsklinikum Ulm /ID# 266962
- Bavaria
  - Erlangen, Bavaria, Germany, 91054
    - Recruiting
    - Universitaetsklinikum Erlangen /ID# 265927
  - Munich, Bavaria, Germany, 81337
    - Recruiting
    - Klinikum der Universitaet Muenchen Grosshadern /ID# 269165
  - Regensburg, Bavaria, Germany, 93042
    - Recruiting
    - Universitaetsklinikum Regensburg /ID# 275556
- Hesse
  - Frankfurt am Main, Hesse, Germany, 60431
    - Recruiting
    - Markus Krankenhaus /ID# 265938
  - Frankfurt am Main, Hesse, Germany, 60590
    - Recruiting
    - Universitaetsklinikum Frankfurt /ID# 266827
  - Fulda, Hesse, Germany, 36043
    - Recruiting
    - Klinikum Fulda /ID# 275228
- Lower Saxony
  - Lüneburg, Lower Saxony, Germany, 21339
    - Recruiting
    - Klinikum Lueneburg /ID# 266886
- North Rhine-Westphalia
  - Essen, North Rhine-Westphalia, Germany, 45147
    - Recruiting
    - Universitaetsmedizin Essen /ID# 275535
- Rhineland-Palatinate
  - Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67067
    - Recruiting
    - St. Marien- und St. Annastiftskrankenhaus /ID# 265912
- Saarland
  - Homburg, Saarland, Germany, 66424
    - Recruiting
    - Universitaetsklinikum des Saarlandes /ID# 265753
- Saxony
  - Dresden, Saxony, Germany, 01307
    - Recruiting
    - Universitaetsklinikum Carl Gustav Carus Dresden /ID# 265931
  - Leipzig, Saxony, Germany, 04103
    - Recruiting
    - Eugastro /ID# 266826
- Saxony-Anhalt
  - Halle, Saxony-Anhalt, Germany, 06108
    - Recruiting
    - Studiengesellschaft BSF Unternehmergesellschaft /ID# 265751
- Schleswig-Holstein
  - Kiel, Schleswig-Holstein, Germany, 24105
    - Recruiting
    - Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 265738
  - Lübeck, Schleswig-Holstein, Germany, 23538
    - Completed
    - Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 267254
Hungary
- - Budapest, Hungary, 1085
    - Recruiting
    - Semmelweis Egyetem /ID# 267068
  - Budapest, Hungary, 1085
    - Recruiting
    - Semmelweis Egyetem /ID# 267064
  - Budapest, Hungary, 1036
    - Completed
    - Synexus Hungary Clinical Research Centre - Budapest /ID# 267384
  - Debrecen, Hungary, 4032
    - Recruiting
    - Debreceni Egyetem /ID# 267389
- Csongrád megye
  - Szeged, Csongrád megye, Hungary, 6720
    - Recruiting
    - Szegedi Tudomanyegyetem /ID# 267386
- Tolna County
  - Szekszárd, Tolna County, Hungary, 7100
    - Recruiting
    - Clinfan /ID# 267385
Ireland
- - Dublin, Ireland, D15 X40D
    - Recruiting
    - Connolly Hospital /ID# 268021
  - Dublin, Ireland, D04 T6F4
    - Recruiting
    - St. Vincent's University Hospital /ID# 267766
  - Dublin, Ireland, D09 XR63
    - Recruiting
    - Beaumont Hospital /ID# 267770
- Donegal
  - Letterkenny, Donegal, Ireland, F92 AE81
    - Recruiting
    - Letterkenny General Hospital /ID# 276677
- Galway
  - Ballinasloe, Galway, Ireland, H53 T971
    - Recruiting
    - Portiuncula University Hospital /ID# 267771
- Louth
  - Drogheda, Louth, Ireland, A92 VW28
    - Recruiting
    - Our Lady of Lourdes Hospital - Drogheda /ID# 267768
- Westmeath
  - Mullingar, Westmeath, Ireland, N91 NA43
    - Recruiting
    - Midland Regional Hospital Mullingar /ID# 267769
Israel
- - Haifa, Israel, 3109601
    - Recruiting
    - Rambam Health Care Campus- Haifa /ID# 267641
- Central District
  - Holon, Central District, Israel, 5822012
    - Recruiting
    - Edith Wolfson Medical Center /ID# 267640
- Southern District
  - Beersheba, Southern District, Israel, 8410101
    - Recruiting
    - Soroka Medical Center /ID# 267235
- Tel Aviv
  - Tel Aviv, Tel Aviv, Israel, 6423906
    - Completed
    - Tel Aviv Sourasky Medical Center /ID# 267307
Italy
- - Catanzaro, Italy, 88100
    - Recruiting
    - Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 267722
  - Messina, Italy, 98125
    - Completed
    - Azienda Ospedaliera Universitaria Gaetano Martino /ID# 267145
  - Milan, Italy, 20122
    - Recruiting
    - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 265949
- Cagliari
  - Monserrato, Cagliari, Italy, 09042
    - Recruiting
    - Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 267287
- Foggia
  - San Giovanni Rotondo, Foggia, Italy, 71013
    - Recruiting
    - Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 267143
- Lombardy
  - Rozzano, Lombardy, Italy, 20089
    - Recruiting
    - IRCCS Istituto Clinico Humanitas /ID# 265946
- Milano
  - Milan, Milano, Italy, 20132
    - Recruiting
    - IRCCS Ospedale San Raffaele /ID# 265951
- Roma
  - Rome, Roma, Italy, 00133
    - Recruiting
    - Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 265935
  - Rome, Roma, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 265940
- Torino
  - Turin, Torino, Italy, 10128
    - Recruiting
    - A.O. Ordine Mauriziano di Torino /ID# 267144
- Verona
  - Negrar, Verona, Italy, 37024
    - Recruiting
    - IRCCS Ospedale Sacro Cuore Don Calabria /ID# 265942
Latvia
- - Liepāja, Latvia, LV-3414
    - Recruiting
    - Liepaja Regional Hospital /ID# 267703
  - Riga, Latvia, LV-1002
    - Recruiting
    - Pauls Stradins Clinical University Hospital /ID# 267705
  - Riga, Latvia, LV-1079
    - Recruiting
    - Digestive Diseases Center GASTRO /ID# 267707
Lithuania
- - Kaunas, Lithuania, 50161
    - Recruiting
    - Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 267695
  - Panevezys, Lithuania, 35144
    - Recruiting
    - Panevezys Republican Hospital /ID# 267709
  - Vilnius, Lithuania, 08661
    - Recruiting
    - Vilnius University Hospital Santaros Klinikos /ID# 267711
Netherlands
- - Groningen, Netherlands, 9713 GR
    - Recruiting
    - Universitair Medisch Centrum Groningen /ID# 265736
  - Utrecht, Netherlands, 3584 CX
    - Recruiting
    - Universitair Medisch Centrum Utrecht /ID# 265731
- North Brabant
  - Tilburg, North Brabant, Netherlands, 5022 GC
    - Recruiting
    - Elisabeth TweeSteden Ziekenhuis /ID# 265729
- North Holland
  - Amsterdam, North Holland, Netherlands, 1105 AZ
    - Recruiting
    - Amsterdam UMC, locatie AMC /ID# 268321
Norway
- - Oslo, Norway, 0450
    - Recruiting
    - Oslo Universitetssykehus Ulleval /ID# 267630
- Akershus
  - Lørenskog, Akershus, Norway, 1478
    - Recruiting
    - Akershus University Hospital /ID# 267642
- Møre og Romsdal
  - Ålesund, Møre og Romsdal, Norway, 6017
    - Recruiting
    - Helse More- og Romsdal HF, Alesund sjukehus /ID# 267632
Poland
- Kuyavian-Pomeranian Voivodeship
  - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-231
    - Recruiting
    - NZOZ Centrum Medyczne KERmed /ID# 266766
  - Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
    - Recruiting
    - Gastromed Sp. z o.o /ID# 266765
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 30-149
    - Recruiting
    - Malopolskie Centrum Kliniczne /ID# 265943
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 03-712
    - Recruiting
    - Bodyclinic Sp. z o.o. sp.k. /ID# 265945
  - Warsaw, Masovian Voivodeship, Poland, 00-728
    - Recruiting
    - Medical Network Sp. z o.o. /ID# 266764
- Pomeranian Voivodeship
  - Sopot, Pomeranian Voivodeship, Poland, 81-756
    - Recruiting
    - Endoskopia Sp. z.o.o. /ID# 265934
- Silesian Voivodeship
  - Tychy, Silesian Voivodeship, Poland, 43-100
    - Recruiting
    - H-T Centrum Medyczne Endoterapia /ID# 265937
- Świętokrzyskie Voivodeship
  - Kielce, Świętokrzyskie Voivodeship, Poland, 25-338
    - Completed
    - Polimedica PTG Kielce /ID# 267066
Portugal
- - Braga, Portugal, 4710-243
    - Recruiting
    - 2CA-Braga, Hospital de Braga /ID# 265894
  - Coimbra, Portugal, 3000-075
    - Recruiting
    - Unidade Local de Saude de Coimbra /ID# 267240
  - Lisbon, Portugal, 1449-005
    - Recruiting
    - Unidade Local de Saude de Lisboa Ocidental /ID# 267242
  - Lisbon, Portugal, 1649-035
    - Recruiting
    - Unidade Local de Saude de Santa Maria /ID# 266113
  - Viana do Castelo, Portugal, 4900-408
    - Recruiting
    - Unidade Local de Saude do Alto Minho, EPE - Hospital de Santa Luzia /ID# 265885
- Braga District
  - Guimarães, Braga District, Portugal, 4835-044
    - Recruiting
    - Unidade Local de Saude do Alto Ave, EPE /ID# 265892
Romania
- Bucharest
  - Bucharest, Bucharest, Romania, 013823
    - Recruiting
    - Memorial Healthcare International S.R.L. /Id# 267328
  - Bucharest, Bucharest, Romania, 020125
    - Recruiting
    - Spitalul Clinic Colentina /ID# 267208
- Cluj
  - Cluj-Napoca, Cluj, Romania, 400380
    - Recruiting
    - Clinica Gastro Med SRL /ID# 267204
- Timiș County
  - Timișoara, Timiș County, Romania, 300239
    - Recruiting
    - OncoHelp Association /ID# 267203
Serbia
- - Novi Sad, Serbia, 21000
    - Recruiting
    - University Clinical Center Vojvodina /ID# 265603
- Beograd
  - Belgrade, Beograd, Serbia, 11000
    - Recruiting
    - University Clinical Hospital Center "Dr. Dragisa Misovic - Dedinje" /ID# 265607
  - Belgrade, Beograd, Serbia, 11000
    - Recruiting
    - Clinical Hospital Center Zvezdara /ID# 265605
  - Belgrade, Beograd, Serbia, 11000
    - Recruiting
    - Military Medical Academy /ID# 267452
  - Belgrade, Beograd, Serbia, 11080
    - Recruiting
    - Clinical Hospital Center Bezanijska Kosa /ID# 265604
- Jablanicki Okrug
  - Leskovac, Jablanicki Okrug, Serbia, 16000
    - Recruiting
    - Leskovac General Hospital /ID# 265606
- Vojvodina
  - Zrenjanin, Vojvodina, Serbia, 23000
    - Recruiting
    - General Hospital Djordje Joanovic /ID# 266040
Singapore
- - Singapore, Singapore, 119074
    - Recruiting
    - National University Hospital /ID# 268128
- Central Singapore
  - Singapore, Central Singapore, Singapore, 258500
    - Recruiting
    - Gleneagles Hospital /ID# 268385
  - Singapore, Central Singapore, Singapore, 228510
    - Recruiting
    - Mount Elizabeth Hospital /ID# 268354
Slovakia
- Banská Bystrica Region
  - Banská Bystrica, Banská Bystrica Region, Slovakia, 975 17
    - Recruiting
    - Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 266064
- Košice Region
  - Košice, Košice Region, Slovakia, 040 01
    - Recruiting
    - Endomed /ID# 266068
    - Contact:
      
      Site Coordinator
      
      Phone Number: +421 905 271 215
      
      Email: fedurco@endomed.sk
- Nitra Region
  - Nitra, Nitra Region, Slovakia, 949 01
    - Recruiting
    - KM Management, spol. s.r.o. /ID# 266070
    - Contact:
      
      Site Coordinator
      
      Phone Number: +421 905 686 916
      
      Email: gregusova.studie@gmail.com
- Presov
  - Prešov, Presov, Slovakia, 080 01
    - Recruiting
    - Gastro I., s.r.o. /ID# 267159
Slovenia
- - Celje, Slovenia, 3000
    - Recruiting
    - General Hospital Celje /ID# 267699
  - Ljubljana, Slovenia, 1000
    - Recruiting
    - University Medical Centre Ljubljana /ID# 267697
South Korea
- - Daegu, South Korea, 41404
    - Recruiting
    - Kyungpook National University Chilgok Hospital /ID# 265487
- Busan Gwang Yeogsi
  - Busan, Busan Gwang Yeogsi, South Korea, 48108
    - Recruiting
    - Inje University Haeundae Paik Hospital /ID# 266380
  - Busan, Busan Gwang Yeogsi, South Korea, 49201
    - Recruiting
    - Dong-A University Medical Center /ID# 266709
- Daejeon Gwang Yeogsi
  - Daejeon, Daejeon Gwang Yeogsi, South Korea, 34943
    - Recruiting
    - The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 265488
- Seoul Teugbyeolsi
  - Dongjak-gu, Seoul Teugbyeolsi, South Korea, 06973
    - Recruiting
    - Chungang University Hospital /ID# 266427
  - Seoul, Seoul Teugbyeolsi, South Korea, 06351
    - Recruiting
    - Samsung Medical Center /ID# 265489
Spain
- - Barcelona, Spain, 08036
    - Completed
    - Hospital Clinic de Barcelona /ID# 265415
  - Madrid, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz /ID# 265412
  - Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de Octubre /ID# 265444
  - Pontevedra, Spain, 36312
    - Recruiting
    - Hospital Alvaro Cunqueiro /ID# 266647
  - Valencia, Spain, 46026
    - Recruiting
    - Hospital Universitari i Politecnic La Fe /ID# 265478
- A Coruna
  - Santiago de Compostela, A Coruna, Spain, 15706
    - Recruiting
    - Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 266902
- Sevilla
  - Seville, Sevilla, Spain, 41009
    - Recruiting
    - Hospital Universitario Virgen Macarena /ID# 266648
  - Seville, Sevilla, Spain, 41013
    - Recruiting
    - Hospital Universitario Virgen del Rocio /ID# 266727
Switzerland
- - Bern, Switzerland, 3012
    - Completed
    - Intesto /ID# 265728
  - Bern, Switzerland, 3010
    - Recruiting
    - Inselspital, Universitaetsspital Bern /ID# 265733
    - Contact:
      
      Site Coordinator
      
      Phone Number: +41 31 632 59 00
- Canton of Zurich
  - Zurich, Canton of Zurich, Switzerland, 8091
    - Recruiting
    - University Hospital Zurich /ID# 275755
Taiwan
- - Taichung, Taiwan, 40447
    - Recruiting
    - China Medical University Hospital /ID# 265924
  - Taipei, Taiwan, 112
    - Recruiting
    - Taipei Veterans General Hospital /ID# 276064
  - Taipei, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital /ID# 265921
  - Taoyuan City, Taiwan, 333
    - Recruiting
    - Linkou Chang Gung Memorial Hospital /ID# 265922
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06230
    - Recruiting
    - Hacettepe Universitesi Tip Fakultesi /ID# 266394
  - Istanbul, Turkey (Türkiye), 34093
    - Recruiting
    - Bezmialem Vakif Universitesi /ID# 266399
  - Istanbul, Turkey (Türkiye), 34093
    - Recruiting
    - Istanbul University Istanbul Medical Faculty /ID# 266299
  - Trabzon, Turkey (Türkiye), 61080
    - Recruiting
    - Karadeniz Teknik Universitesi Tip Fakultesi /ID# 266303
- Kocaeli
  - Dilovası, Kocaeli, Turkey (Türkiye), 41455
    - Recruiting
    - Kocaeli University Research and Application Hospital /ID# 267772
United Kingdom
- - Bristol, United Kingdom, BS8 2RA
    - Recruiting
    - Velocity Clinical Research - Bristol /ID# 275736
  - Cardiff, United Kingdom, CF14 4XW
    - Recruiting
    - University Hospital of Wales /ID# 275702
  - Newcastle upon Tyne, United Kingdom, NE1 4LP
    - Recruiting
    - Royal Victoria Infirmary /ID# 268064
- Edinburgh, City of
  - Edinburgh, Edinburgh, City of, United Kingdom, EH4 2XU
    - Recruiting
    - Western General Hospital - NHS Lothian /ID# 266333
- Glasgow City
  - Glasgow, Glasgow City, United Kingdom, G12 0YN
    - Recruiting
    - Gartnavel General Hospital /ID# 266407
- Greater London
  - London, Greater London, United Kingdom, NW3 2QG
    - Recruiting
    - Royal Free Hospital /ID# 268065
  - London, Greater London, United Kingdom, SE1 9RT
    - Recruiting
    - Guy's Hospital /ID# 266336
  - London, Greater London, United Kingdom, SW17 0QT
    - Recruiting
    - St George University Hospitals NHS Foundation Trust /ID# 266335
  - London, Greater London, United Kingdom, E1 2ES
    - Recruiting
    - Barts Health NHS Trust /ID# 266410
- Oxfordshire
  - Oxford, Oxfordshire, United Kingdom, OX3 9DU
    - Recruiting
    - The John Radcliffe Hospital /ID# 266334
- Warwickshire
  - Coventry, Warwickshire, United Kingdom, CV2 2DX
    - Completed
    - University Hospital Coventry & Warwickshire NHS Trust /ID# 267128
- West Midlands
  - Wolverhampton, West Midlands, United Kingdom, WV10 0QP
    - Recruiting
    - New Cross Hospital - The Royal Wolverhampton NHS Trust /ID# 268158
United States
- Alabama
  - Dothan, Alabama, United States, 36301
    - Recruiting
    - Digestive Health Specialists /ID# 266216
  - Mobile, Alabama, United States, 36606
    - Recruiting
    - East View Medical Research /ID# 270377
- California
  - Coronado, California, United States, 92118
    - Recruiting
    - Southern California Res. Ctr /ID# 265549
  - La Jolla, California, United States, 92037
    - Recruiting
    - UC San Diego Health System /ID# 265565
  - Sacramento, California, United States, 95817
    - Recruiting
    - uc davis medical center - patient support services building /ID# 265554
  - San Diego, California, United States, 92103
    - Recruiting
    - Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Recruiting
    - Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Recruiting
    - Danbury Hospital, Western Connecticut Health Network /ID# 265556
  - New Haven, Connecticut, United States, 06510
    - Recruiting
    - Yale University School of Medicine /ID# 266786
- Florida
  - Clermont, Florida, United States, 34711
    - Recruiting
    - Novum Research /ID# 278128
  - Gainesville, Florida, United States, 32610
    - Recruiting
    - University of Florida College of Medicine /ID# 266930
  - Inverness, Florida, United States, 34452-4717
    - Recruiting
    - Nature Coast Clinical Research - Inverness /ID# 265874
  - Margate, Florida, United States, 33063
    - Recruiting
    - Atlantic Medical Research /ID# 266207
  - Miami, Florida, United States, 33144
    - Recruiting
    - A Plus Research /ID# 265878
  - Miami, Florida, United States, 33157
    - Recruiting
    - Sanchez Clinical Research /ID# 265887
  - New Port Richey, Florida, United States, 34653
    - Recruiting
    - Advanced Research Institute, Inc /ID# 265548
  - Orange City, Florida, United States, 32763
    - Recruiting
    - Hillcrest Medical Research, LLC /ID# 267237
  - Orlando, Florida, United States, 32803
    - Recruiting
    - Endoscopic Research, Inc. /ID# 267211
  - Tampa, Florida, United States, 33613
    - Recruiting
    - AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538
  - Tampa, Florida, United States, 33609
    - Recruiting
    - Gcp Clinical Research /ID# 278126
  - Zephyrhills, Florida, United States, 33542
    - Recruiting
    - Florida Medical Clinic - Zephyrhills /ID# 267392
- Georgia
  - Macon, Georgia, United States, 31201
    - Recruiting
    - Gastroenterology Associates of Central Georgia /ID# 265547
    - Contact:
      
      Site Coordinator
      
      Phone Number: 478-742-2600
- Idaho
  - Boise, Idaho, United States, 83706
    - Recruiting
    - Treasure Valley Medical Research /ID# 267114
- Illinois
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - University of Chicago Medical Center /ID# 267400
  - Peoria, Illinois, United States, 61637-0001
    - Recruiting
    - OSF St. Francis Medical Center /ID# 266973
  - Springfield, Illinois, United States, 62703-2403
    - Recruiting
    - Springfield Clinic Main Campus /ID# 267434
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - Indiana University Health University Hospital /ID# 278129
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - Recruiting
    - University of Kentucky Chandler Medical Center. /ID# 265564
- Maryland
  - Chevy Chase, Maryland, United States, 20815
    - Recruiting
    - Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877
  - Rockville, Maryland, United States, 20854
    - Recruiting
    - Velocity Clinical Research - Rockville /ID# 267712
- Massachusetts
  - New Bedford, Massachusetts, United States, 02740
    - Recruiting
    - Lucida Clinical Trials /ID# 266548
- Michigan
  - Novi, Michigan, United States, 48377
    - Recruiting
    - Henry Ford Medical Center - Columbus /ID# 266503
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Mayo Clinic-Rochester /ID# 265550
- Missouri
  - Columbia, Missouri, United States, 65201
    - Recruiting
    - GI Associates Research, LLC /ID# 267433
  - Liberty, Missouri, United States, 64068
    - Recruiting
    - Bvl Research /ID# 265870
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University /ID# 266938
- Nevada
  - Las Vegas, Nevada, United States, 89128
    - Recruiting
    - Vector Clinical Trials /ID# 265561
- New York
  - Lake Success, New York, United States, 11042
    - Recruiting
    - Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 265566
  - New York, New York, United States, 10075
    - Recruiting
    - Northwell Health-Lenox Hill Hospital /ID# 265527
  - New York, New York, United States, 10029
    - Completed
    - Icahn School of Medicine at Mount Sinai /ID# 266857
  - Yonkers, New York, United States, 10701
    - Recruiting
    - Care Access - Yonkers /ID# 266781
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Recruiting
    - Digestive Health Partners - Biltmore Office /ID# 265539
- Ohio
  - Cincinnati, Ohio, United States, 45267-2827
    - Recruiting
    - University of Cincinnati /ID# 265589
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - The Ohio State University /ID# 265577
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Recruiting
    - Digestive Disease Specialists - Oklahoma /ID# 265901
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Completed
    - Penn State Health Milton South Hershey Medical Center /ID# 267126
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - University of Pennsylvania /ID# 265904
- South Carolina
  - Orangeburg, South Carolina, United States, 29118
    - Recruiting
    - Gastroenterology Associates of Orangeburg /ID# 267548
- Tennessee
  - Johnson City, Tennessee, United States, 37604
    - Recruiting
    - GI associates of Northeast Tennessee /ID# 265567
- Texas
  - Cedar Park, Texas, United States, 78613
    - Recruiting
    - Gi Alliance - Cedar Park /ID# 268153
  - El Paso, Texas, United States, 79902
    - Completed
    - Proactive Clinical Research /ID# 267305
  - Garland, Texas, United States, 75044
    - Completed
    - Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 266935
  - Houston, Texas, United States, 77030
    - Recruiting
    - Houston Methodist Hospital /ID# 265533
  - Lubbock, Texas, United States, 79424
    - Recruiting
    - Caprock Gastro Research - Lubbock - 80th Street /ID# 265541
  - Mansfield, Texas, United States, 76063
    - Recruiting
    - GI Alliance: Mansfield /ID# 266947
  - San Antonio, Texas, United States, 78215
    - Recruiting
    - Sun Research Institute /ID# 266723
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Southern Star Research Institute /ID# 278124
  - San Antonio, Texas, United States, 78212
    - Completed
    - Clinical Associates in Research Therapeutics of America, LLC /ID# 265899
  - Southlake, Texas, United States, 76092
    - Completed
    - Texas Digestive Disease Consultants - Southlake /ID# 265576
  - Tyler, Texas, United States, 75701
    - Recruiting
    - Tyler Research Institute /ID# 265545
- Utah
  - Ogden, Utah, United States, 84403
    - Recruiting
    - Care Access - Ogden /ID# 266428
  - Salt Lake City, Utah, United States, 84124
    - Completed
    - Care Access - Salt Lake City /ID# 266785
- Washington
  - Seattle, Washington, United States, 98101
    - Recruiting
    - Virginia Mason Hospital & Medical Center /ID# 265574
  - Tacoma, Washington, United States, 98405
    - Recruiting
    - Washington Gastroenterology - Tacoma /ID# 267302

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

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Participants' body weight must be >= 40 kg at Baseline.
Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.
CDAI >= 220 at Baseline.
Endoscopic evidence of mucosal inflammation as documented by an SES-CD of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.
Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules.

Exclusion Criteria:

Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.
Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.

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: Sequential Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monotherapy: Risankizumab Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection.	Drug: Risankizumab Subcutaneous Injection Drug: Risankizumab Intravenous Infusion
Experimental: Combination Therapy: Risankizumab and Lutikizumab Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and Lutikizumab Dose A, Dose B and Dose C as SC injection.	Drug: Risankizumab Subcutaneous Injection Drug: Risankizumab Intravenous Infusion Drug: Lutikizumab Subcutaneous Injection
Experimental: Monotherapy: Lutikizumab Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection.	Drug: Lutikizumab Subcutaneous Injection
Experimental: Long-Term Extension: Risankizumab Monotherapy Participants will receive Risankizumab Dose A as IV infusion and/or Risankizumab Dose B as SC injection for up to 72 weeks.	Drug: Risankizumab Subcutaneous Injection Drug: Risankizumab Intravenous Infusion
Experimental: Combination Therapy: Risankizumab and Trosunilimab Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.	Drug: Risankizumab Subcutaneous Injection Drug: Risankizumab Intravenous Infusion Drug: Trosunilimab Intravenous Infusion Drug: Trosunilimab Subcutaneous Injection
Experimental: Monotherapy: Trosunilimab Participants will receive trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.	Drug: Trosunilimab Intravenous Infusion Drug: Trosunilimab Subcutaneous Injection
Experimental: Monotherapy: ABBV-8736 - OUS Only Participants will receive ABBV-8736 as IV infusion.	Drug: ABBV-8736 Intravenous Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Achieve Endoscopic Remission Time Frame: Week 12	The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Remission is defined as SES-CD ≤ 4 and no sub score greater than 1 in any individual variable, as scored by a central reader.	Week 12
Number of Participants with Adverse Events (AEs) Time Frame: Up to approximately 96 weeks	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to approximately 96 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) Time Frame: Week 12	The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI < 150	Week 12
Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS) Time Frame: Week 12	SF/APS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.	Week 12
Percentage of Participants who Achieve Endoscopic Response Time Frame: Week 12	The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Response is defined as a decrease in SES-CD ≥ 50% from Baseline, as scored by central reader.	Week 12

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.

Helpful Links

Related Info

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)

September 4, 2024

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M24-885
2024-513009-30-00 (Ctis)

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

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

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

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

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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Clinical Trials on Risankizumab

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