Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD) (SEQUENCE)

A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI).

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide.

In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. 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, checking for side effects and completing questionnaires.

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn's Disease (CD)
• Intervention / Treatment: Drug: Risankizumab; Drug: Risankizumab; Drug: Ustekinumab; Drug: Ustekinumab

• Study Type: Interventional
• Enrollment (Actual): 527
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, 5016
    • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 223433
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, 1280
      • Hospital Britanico de Buenos Aires /ID# 223432
  • Buenos Aires F.D.
    • Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina, 1199
      • Hospital Italiano de Buenos Aires /ID# 224550
    • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1027
      • CINME Centro de Investigaciones Metabolicas /ID# 223447
    • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1115
      • Gedyt /ID# 224698
    • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1431
      • Duplicate_CEMIC /ID# 223670
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Duplicate_Sanatorio 9 de Julio /ID# 226086
• Australia
  • New South Wales
    • Wollongong, New South Wales, Australia, 2500
      • Wollongong Hospital /ID# 224688
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Misericordiae Limited /ID# 223642
    • Southport, Queensland, Australia, 4222
      • Griffith University /ID# 223641
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Lyell McEwin Hospital /ID# 223643
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health - Monash Medical Centre /ID# 224599
• Austria
  • Lower Austria
    • Sankt Pölten, Lower Austria, Austria, 3100
      • Universitaetsklinikum St. Poelten /ID# 223437
  • State of Vienna
    • Vienna, State of Vienna, Austria, 1090
      • Medizinische Universitaet Wien /ID# 223438
  • Upper Austria
    • Linz, Upper Austria, Austria, 4010
      • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 223440
• Belgium
  • Ghent, Belgium, 9000
    • AZ Maria Middelares /ID# 223908
  • Liège, Belgium, 4000
    • Duplicate_CHU de Liege /ID# 223904
  • Antwerpen
    • Merksem, Antwerpen, Belgium, 2170
      • ZAS Palfijn /ID# 223907
  • Brussels Capital
    • Anderlecht, Brussels Capital, Belgium, 1070
      • Universite Libre de Bruxelles - Hopital Erasme /ID# 223902
    • Brussels, Brussels Capital, Belgium, 1200
      • Cliniques Universitaires UCL Saint-Luc /ID# 223900
  • Liege
    • Liège, Liege, Belgium, 4000
      • Groupe Sante CHC - Clinique du MontLegia /ID# 223898
  • Namur
    • Godinne, Namur, Belgium, 5530
      • Duplicate_CHU UCL Namur - site Godinne /ID# 223905
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent /ID# 223899
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
      • Vitaz /Id# 224511
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 223901
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • AZ-Delta. /ID# 223896
• Brazil
  • La Spezia
    • Santo André, La Spezia, Brazil, 09060-870
      • Faculdade de Medicina do ABC /ID# 223231
  • São Paulo
    • Botucatu, São Paulo, Brazil, 18618-686
      • Upeclin Fmb - Unesp /Id# 223234
    • Ribeirão Preto, São Paulo, Brazil, 14049-900
      • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 223233
    • São José do Rio Preto, São Paulo, Brazil, 15015-110
      • Kaiser Clinica e Hospital Dia /ID# 223232
• Bulgaria
  • Plovdiv, Bulgaria, 4001
    • Umbal Kaspela /ID# 223415
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda University Hospital EAD /ID# 223757
  • Sofia, Bulgaria, 1233
    • MHAT Knyaginya Klementina /ID# 223425
  • Sofia
    • Sofiya, Sofia, Bulgaria, 1527
      • Hospital Tsaritsa Yoanna /ID# 223822
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Duplicate_University of Calgary /ID# 223750
    • Edmonton, Alberta, Canada, T5R 1W2
      • Allen Whey Khye Lim Professional Corporation /ID# 223755
    • Edmonton, Alberta, Canada, T6K 4B2
      • Covenant Health /ID# 223753
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Fraser Clinical Trials Inc /ID# 223742
    • Victoria, British Columbia, Canada, V8V 3M9
      • Percuro Clinical Research, Ltd /ID# 223747
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QEII - Health Sciences Centre /ID# 223748
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre - University Hospital /ID# 223741
    • North Bay, Ontario, Canada, P1B 2H3
      • Scott Shulman Medicine Professional Corporation /ID# 223754
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital /ID# 223752
    • Toronto, Ontario, Canada, M9V 0A9
      • Axler, Toronto, ON. Canada /ID# 223740
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • CISSS de la Monteregie /ID# 224399
    • Lévis, Quebec, Canada, G6V 3Z1
      • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 223744
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital- McGill University Health Center /ID# 223743
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Duplicate_Duplicate_CHUS - Hopital Fleurimont /ID# 224819
• Chile
  • Bio-Bio
    • Concepción, Bio-Bio, Chile, 4070038
      • Hospital Guillermo Grant Benavente de Concepción /ID# 223668
    • Talcahuano, Bio-Bio, Chile, 1740000
      • Hospital Las Higueras /ID# 223669
  • Region Metropolitana Santiago
    • Providencia, Region Metropolitana Santiago, Chile, 7510086
      • Sociedad de Servicios Medicos Walsen Galmez Ltda. /ID# 224032
• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital /ID# 224832
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital /ID# 224479
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400013
      • Chongqing General Hospital /ID# 232305
  • Fujian
    • Xiamen, Fujian, China, 361004
      • Zhongshan Hospital Xiamen University /ID# 224663
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital of Southern Medical University /ID# 224524
    • Guangzhou, Guangdong, China, 510655
      • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 224416
  • Henan
    • Zhengzhou, Henan, China, 450014
      • The Second Affiliated Hospital of Zhengzhou University /ID# 224528
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224545
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University /ID# 224525
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Tongji Medical College of HUST /ID# 224428
  • Hunan
    • Changsha, Hunan, China, 410013
      • Duplicate_The Third Xiangya Hospital of Central South University /ID# 224754
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital Of Central South University /ID# 224684
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • Changzhou No.2 Peoples Hospital /ID# 238965
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital /ID# 224746
    • Wuxi, Jiangsu, China, 214023
      • Wuxi People's Hospital /ID# 224426
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University /ID# 224507
  • Liaoning
    • Shenyang, Liaoning, China, 110022
      • Shengjing Hospital of China Medical University /ID# 224478
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200127
      • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 224420
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University /ID# 224786
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 224662
    • Hangzhou, Zhejiang, China, 310018
      • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 224421
• Czechia
  • Hradec Králové, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s.r.o. /ID# 223277
  • Pardubice, Czechia, 530 03
    • Nemocnice Pardubickeho kraje, a.s. /ID# 223256
  • Prague, Czechia, 140 00
    • Axon Clinical, s.r.o. /ID# 223260
  • Prague, Czechia, 155 00
    • Nemocnice Horovice - NH Hospital a.s /ID# 223276
  • České Budějovice, Czechia, 370 01
    • Nemocnice Ceske Budejovice a.s. /ID# 224219
  • Praha 9
    • Prague, Praha 9, Czechia, 190 00
      • Iscare Klinické Centrum /ID# 223279
• France
  • Nantes, France, 44300
    • Clinique Jules Verne /ID# 223870
  • Nîmes, France, 30932
    • Polyclinique Grand Sud /ID# 224092
  • Toulouse, France, 31059
    • Hopital Universitaire Purpan Hopital Rangueil /ID# 224732
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • Chu de Nice-Hopital Larchet Ii /Id# 223763
  • Auvergne-Rhône-Alpes
    • Clermont, Auvergne-Rhône-Alpes, France, 63100
      • CHU Clermont-Ferrand /ID# 224529
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13015
      • APHM - Hopital Nord /ID# 223869
  • Gironde
    • Pessac, Gironde, France, 33604
      • Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 223764
  • Herault
    • Montpellier, Herault, France, 34295
      • CHU Montpellier - Hopital Saint Eloi /ID# 223860
  • Isere
    • La Tronche, Isere, France, 38700
      • Duplicate_CHU Grenoble - Hopital Michallon /ID# 224091
  • Marne
    • Reims, Marne, France, 51092
      • CHU Reims - Hôpital Robert Debre /ID# 224530
  • Meurthe-et-Moselle
    • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
      • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 223767
  • Nord
    • Lille, Nord, France, 59037
      • CHRU Lille - Hopital Claude Huriez /ID# 223765
  • Pays de la Loire Region
    • Nantes, Pays de la Loire Region, France, 44000
      • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 241098
    • St-Priest-en-Jarez, Pays de la Loire Region, France, 42270
      • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 223768
  • Île-de-France Region
    • Clichy, Île-de-France Region, France, 92110
      • Hopital Beaujon /ID# 223863
    • Neuilly-sur-Seine, Île-de-France Region, France, 92200
      • Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249859
• Germany
  • Berlin, Germany, 10825
    • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 223411
  • Berlin, Germany, 14050
    • DRK Kliniken Berlin Westend /ID# 223412
  • Berlin, Germany, 10318
    • Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 229110
  • Berlin, Germany, 13353
    • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 223405
  • Berlin-Zehlendorf, Germany, 14163
    • Krankenhaus Waldfriede /ID# 223397
  • Münster, Germany, 48155
    • Medizinisches Versorgungszentrum Portal 10 /ID# 224552
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Universitaetsklinikum Freiburg /ID# 223406
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • Universitatsklinikum Mannheim /ID# 223410
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Universitaetsklinikum Ulm /ID# 223400
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Universitaetsklinikum Erlangen /ID# 223404
    • Regensburg, Bavaria, Germany, 93053
      • Universitatsklinik Regensburg /ID# 223407
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60431
      • Duplicate_Agaplesion Markus Krankenhaus /ID# 223673
    • Frankfurt am Main, Hesse, Germany, 60590
      • Duplicate_Universitaetsklinikum Frankfurt /ID# 223396
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Medizinische Hochschule Hannover /ID# 223402
    • Lüneburg, Lower Saxony, Germany, 21339
      • Klinikum Lueneburg /ID# 223408
  • North Rhine-Westphalia
    • Grevenbroich, North Rhine-Westphalia, Germany, 41515
      • Praxiszentrum fuer Gastroenterologie /ID# 223409
  • Saarland
    • Saarbrücken, Saarland, Germany, 66111
      • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 223482
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Duplicate_Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 223403
    • Leipzig, Saxony, Germany, 04103
      • Eugastro /ID# 223401
  • Saxony-Anhalt
    • Magdeburg, Saxony-Anhalt, Germany, 39120
      • Otto-von-Guericke-Universitaet /ID# 223413
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 223395
• Greece
  • Athens, Greece, 10676
    • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 223338
  • Ioannina, Greece, 45500
    • University General Hospital of Ioannina /ID# 223339
  • Thessaloniki, Greece, 54642
    • General Hospital of Thessaloniki Hippokrateio /ID# 223887
  • Attica
    • Athens, Attica, Greece, 11527
      • General Hospital of Athens Ippokratio /ID# 223344
    • Athens, Attica, Greece, 11527
      • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 223342
    • Nikaia, Attica, Greece, 18454
      • General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 223340
  • Crete
    • Heraklion, Crete, Greece, 71500
      • University General Hospital of Heraklion PA.G.N.I /ID# 223336
• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft /ID# 223775
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 223772
  • Csongrád megye
    • Szeged, Csongrád megye, Hungary, 6725
      • Duplicate_Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 223774
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 223773
  • Tolna County
    • Szekszárd, Tolna County, Hungary, 7100
      • Duplicate_Clinfan Szolgaltato Kft. /ID# 224751
• Israel
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center. /ID# 223558
  • Central District
    • Ẕerifin, Central District, Israel, 70300
      • Yitzhak Shamir Medical Center /ID# 224686
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 91031
      • Shaare Zedek Medical Center /ID# 223549
  • Southern District
    • Ashkelon, Southern District, Israel, 5822000
      • The Edith Wolfson Medical Center /ID# 227652
    • Beersheba, Southern District, Israel, 8410101
      • Soroka University Medical Center /ID# 223556
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 223557
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 223551
• Italy
  • Cagliari, Italy, 09121
    • Azienda Ospedaliera G. Brotzu /ID# 241165
  • Cagliari, Italy, 09124
    • Duplicate_Ospedale San Giovanni Di Dio - Cagliari /ID# 223474
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 223324
  • Palermo, Italy, 90146
    • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 223333
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 223330
  • Genova
    • Genoa, Genova, Italy, 16132
      • Duplicate_Ospedale Policlinico San Martino /ID# 223329
  • Milano
    • Milan, Milano, Italy, 20132
      • Duplicate_Ospedale San Raffaele IRCCS /ID# 241167
    • Milan, Milano, Italy, 20157
      • ASST Fatebenefratelli Sacco /ID# 223322
    • Rho, Milano, Italy, 20017
      • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 223335
  • Roma
    • Rome, Roma, Italy, 00133
      • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 223332
    • Rome, Roma, Italy, 00149
      • Azienda Ospedaliera San Camillo Forlanini /ID# 223325
    • Rome, Roma, Italy, 00168
      • Duplicate_Policlinico Agostino Gemelli /ID# 223323
  • Verona
    • Negrar, Verona, Italy, 37024
      • Duplicate_IRCCS Ospedale Sacro Cuore Don Calabria /ID# 223327
• Mexico
  • Veracruz, Mexico, 91900
    • Faicic S de Rl de Cv /Id# 226990
  • Estado de Baja California
    • Mexicali, Estado de Baja California, Mexico, 21200
      • Centro de Investigacion en Artritis y Osteoporosis S.C. /ID# 227179
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44600
      • BRCR Global Mexico /ID# 223970
  • Nuevo León
    • San Pedro Garza García, Nuevo León, Mexico, 66278
      • Centro Medico Zambrano Hellion /ID# 224025
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • Medical Care & Research SA de CV /ID# 223974
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht /ID# 223696
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud Universitair Medisch Centrum /ID# 233750
  • North Brabant
    • Tilburg, North Brabant, Netherlands, 5022 GC
      • Elisabeth Tweesteden Ziekenhuis /ID# 223229
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1105 AZ
      • Amsterdam UMC, locatie AMC /ID# 223228
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
      • Gastromed Sp. z o.o /ID# 223705
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-149
      • Malopolskie Centrum Kliniczne /ID# 223708
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 03-580
      • Vivamed Sp. z o.o. /ID# 223706
• Romania
  • Bucharest, Romania, 011025
    • Sana Monitoring /Id# 223682
  • Bucharest, Romania, 020121
    • Spitalul Clinic Colentina /ID# 223680
  • Timișoara, Romania, 300002
    • Cabinet Particular Policlinic Algomed /ID# 223578
  • Târgu Mureş, Romania, 540136
    • Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 224017
  • Târgu Mureş, Romania, 540136
    • Targu Mures Emergency Clinical County Hospital /ID# 223613
  • București
    • Bucharest, București, Romania, 022328
      • Duplicate_Institutul Clinic Fundeni /ID# 223914
    • Bucharest, București, Romania, 050098
      • Duplicate_Univ Emergency Hosp Bucharest /ID# 223579
• Russia
  • Moscow, Russia, 123423
    • National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 224222
  • Saint Petersburg, Russia, 197110
    • City Clinical Hospital No. 31 /ID# 224223
  • Kaliningrad Oblast
    • Kaliningrad, Kaliningrad Oblast, Russia, 236016
      • Immanuel Kant Baltic Federal University /ID# 224224
• Slovakia
  • Banská Bystrica Region
    • Banská Bystrica, Banská Bystrica Region, Slovakia, 975 17
      • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 223302
  • Nitra Region
    • Nitra, Nitra Region, Slovakia, 949 01
      • KM Management, spol. s.r.o. /ID# 223304
    • Nové Zámky, Nitra Region, Slovakia, 940 34
      • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224580
  • Presov
    • Prešov, Presov, Slovakia, 080 01
      • Duplicate_GASTRO I., s.r.o. /ID# 223303
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1820
      • Lenasia Clinical Trial Centre /ID# 224306
  • Western Cape
    • CAPE TOWN Milnerton, Western Cape, South Africa, 7441
      • Spoke Research Inc /ID# 223803
    • Cape Town, Western Cape, South Africa, 7500
      • Dr MJ Prins /ID# 224304
    • Cape Town, Western Cape, South Africa, 7800
      • Private Practice Dr MN Rajabally /ID# 223805
• South Korea
  • Daejeon Gwang Yeogsi
    • Junggu, Daejeon Gwang Yeogsi, South Korea, 34943
      • Duplicate_The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456
  • Gyeongsangnam-do
    • 서구, Gyeongsangnam-do, South Korea, 49201
      • Duplicate_Dong-A University Hospital /ID# 223455
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03181
      • Duplicate_Kangbuk Samsung Hospital /ID# 223452
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center /ID# 223453
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante Doctor Balmis /ID# 223552
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 223355
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 223317
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 223318
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos /ID# 223367
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena /ID# 223315
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 223476
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia /ID# 223321
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 223314
  • A Coruna
    • Ferrol, A Coruna, Spain, 15405
      • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 223356
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 226554
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 223436
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Duplicate_Hospital Universitario de Bellvitge /ID# 225719
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Hospital Universitario de Fuenlabrada /ID# 223371
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 223319
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias /ID# 223368
• Sweden
  • Falun, Sweden, 791 31
    • Duplicate_Falu Lasarett /ID# 227222
  • Stockholm, Sweden, 182 88
    • Danderyds sjukhus AB /ID# 223363
  • Stockholm County
    • Solna, Stockholm County, Sweden, 171 64
      • Karolinska University Hospital Solna /ID# 223423
    • Stockholm, Stockholm County, Sweden, 114 28
      • GHP Stockholm Gastro Center /ID# 223420
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitaetsspital Bern /ID# 223590
  • Canton of Basel-City
    • Basel Town, Canton of Basel-City, Switzerland, 4031
      • University Hospital Basel /ID# 223711
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • Duplicate_Universitatsspital Zurich /ID# 223712
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06590
    • Ankara Univ Medical Faculty /ID# 223388
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 223387
  • Mersin, Turkey (Türkiye), 33343
    • Mersin University Medical /ID# 223385
  • Ankara
    • Yenimahalle, Ankara, Turkey (Türkiye), 06560
      • Gazi Universitesi Tip Fakultes /ID# 223386
• Ukraine
  • Kyiv, Ukraine, 01030
    • Kyiv City Clinical Hospital No.18 /ID# 223700
  • Zaporizhzhia, Ukraine, 69076
    • Medical Center of LLC DIASERVIS /ID# 224249
  • Lviv Oblast
    • Lviv, Lviv Oblast, Ukraine, 79010
      • Lviv Regional Clinical Hospital /ID# 223661
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Belfast Health and Social Care Trust /ID# 224023
  • Huddersfield, United Kingdom, HX3 0PW
    • Calderdale and Huddersfield NHS Foundation Trust /ID# 223654
  • Newcastle upon Tyne, United Kingdom, NE3 3HD
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 223655
  • Salford, United Kingdom, M6 8HD
    • Northern Care Alliance NHS Group /ID# 223650
  • Stirling, United Kingdom, FK9 4SW
    • NHS Forth Valley /ID# 224657
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Addenbrookes Hospital /ID# 223648
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon & Exeter Hospital /ID# 223644
  • Edinburgh, City of
    • Edinburgh, Edinburgh, City of, United Kingdom, EH4 2XU
      • Western General Hospital - NHS Lothian /ID# 223646
  • Greater London
    • London, Greater London, United Kingdom, E1 2ES
      • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 223651
    • London, Greater London, United Kingdom, SE1 7EH
      • St Thomas' Hospital - Guy's and St Thomas' NHS Foundation Trust /ID# 223647
    • London, Greater London, United Kingdom, SE5 9RS
      • Kings College Hospital NHS Foundation Trust /ID# 223649
    • London, Greater London, United Kingdom, SW17 0QT
      • St George University Hospitals NHS Foundation Trust /ID# 223656
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • University Hospital Southampton NHS Foundation Trust /ID# 224351
  • Hertfordshire
    • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
      • East and North Hertfordshire NHS Trust /ID# 224607
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G51 4TF
      • Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 223653
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Duplicate_Nottingham University Hospitals NHS Trust /ID# 224179
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Oxford University Hospitals NHS Foundation Trust /ID# 223645
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224-1636
      • Advanced Gastroenterology, P.C /ID# 224396
  • California
    • Coronado, California, United States, 92118-1408
      • Southern California Res. Ctr. /ID# 223484
    • Irvine, California, United States, 92618
      • Hoag Memorial Hosp Presbyterian /ID# 224373
    • Los Alamitos, California, United States, 90720-3309
      • United Medical Doctors /ID# 223486
    • Los Angeles, California, United States, 90048
      • TLC Clinical Research Inc /ID# 223467
    • Sacramento, California, United States, 95817
      • Duplicate_UC Davis Medical Center /ID# 225700
    • San Francisco, California, United States, 94158
      • Duplicate_University of California, San Francisco /ID# 223621
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Duplicate_Western Connecticut Medical Group /ID# 223478
    • Hamden, Connecticut, United States, 06518
      • Duplicate_Medical Research Center of CT /ID# 223540
    • New Haven, Connecticut, United States, 06510
      • Yale Univ Digestive Diseases /ID# 224463
  • Florida
    • DeBary, Florida, United States, 32713-2260
      • Omega Research Maitland, LLC /ID# 223463
    • Inverness, Florida, United States, 34452-4717
      • Nature Coast Clinical Research - Inverness /ID# 223600
    • Miami, Florida, United States, 33136
      • University of Miami /ID# 223496
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Naples /ID# 223516
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute, Inc /ID# 223470
    • Orlando, Florida, United States, 32803
      • Endoscopic Research, Inc. /ID# 223505
    • Tampa, Florida, United States, 33612
      • Duplicate_University of South Florida /ID# 224733
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastro Assoc /ID# 223537
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia, LLC /ID# 223525
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Duplicate_The University of Chicago DCAM /ID# 223520
    • Evanston, Illinois, United States, 60201
      • NorthShore University-Endeavor Health Evanston Hospital /ID# 223538
    • Oak Lawn, Illinois, United States, 60453
      • Southwest Gastroenterology /ID# 223509
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital /ID# 223471
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • GI Alliance /ID# 223508
    • New Orleans, Louisiana, United States, 70115
      • Nola Research Works, LLC /ID# 223489
    • Shreveport, Louisiana, United States, 71105-6800
      • Louisiana Research Center, LLC /ID# 223503
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Duplicate_MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 223499
    • Columbia, Maryland, United States, 21045
      • Gastro Center of Maryland /ID# 223518
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /Id# 224335
    • Boston, Massachusetts, United States, 02215-5400
      • Beth Israel Deaconess Medical Center /ID# 228094
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597
    • Flint, Michigan, United States, 48504
      • AA Medical Research Center - Flint /ID# 224384
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 223506
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Las Vegas Medical Research /ID# 223533
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Univ New Mexico /ID# 223515
  • New York
    • Brooklyn, New York, United States, 11235
      • NY Scientific /ID# 223479
    • Burnt Hills, New York, United States, 12027
      • Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048
    • Fresh Meadows, New York, United States, 11366
      • Intercity Advanced Gastroentertology Center /ID# 224313
    • New Hyde Park, New York, United States, 11040
      • North Shore University Hospital /ID# 224356
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital /ID# 223687
    • New York, New York, United States, 10032-3725
      • Columbia Univ Medical Center /ID# 224215
    • New York, New York, United States, 10075
      • Lenox Hill Hospital /ID# 223534
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514-4220
      • Univ NC Chapel Hill /ID# 224405
    • Winston-Salem, North Carolina, United States, 27157-0001
      • Duplicate_Atrium Health Wake Forest Baptist Medical Center /ID# 224406
  • North Dakota
    • Fargo, North Dakota, United States, 58104-5925
      • Plains Clinical Research Center, LLC /ID# 223522
  • Ohio
    • Cincinnati, Ohio, United States, 45219-2364
      • University of Cincinnati Medical Center /ID# 224614
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus /ID# 223691
    • Springboro, Ohio, United States, 45066-1615
      • DSI Research, LLC /ID# 234116
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical /ID# 223566
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists /ID# 223528
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-2360
      • Penn State Milton S. Hershey Medical Center /ID# 224216
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group, PC /ID# 223910
    • Wyomissing, Pennsylvania, United States, 19610
      • Digestive Disease Associates, LTD - Wyomissing /ID# 223462
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina /ID# 223485
    • Columbia, South Carolina, United States, 29203-8902
      • Consultants in Gastroenterology - Columbia NE /ID# 224263
    • Greenville, South Carolina, United States, 29607
      • Gastroenterology Associates, P.A. of Greenville /ID# 223497
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Gastro One /ID# 223539
    • Nashville, Tennessee, United States, 37232-0011
      • Vanderbilt University Medical Center /ID# 224610
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 223512
    • Garland, Texas, United States, 75044-2208
      • Duplicate_DHAT Research Institute /ID# 223521
    • Houston, Texas, United States, 77017-2337
      • Vilo Research Group Inc /ID# 223513
    • Houston, Texas, United States, 77030-3411
      • Duplicate_Baylor College of Medicine - Baylor Medical Center /ID# 223488
    • San Antonio, Texas, United States, 78212
      • Clinical Associates in Research Therapeutics of America, LLC /ID# 223510
    • San Antonio, Texas, United States, 78229-5390
      • Southern Star Research Institute, LLC /ID# 223598
    • Southlake, Texas, United States, 76092
      • Texas Digestive Disease Consultants - Southlake /ID# 224264
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC /ID# 223469
  • Vermont
    • Burlington, Vermont, United States, 05401-1473
      • University of Vermont Medical Center /ID# 224047
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Richmond VA Medical Center /ID# 223586
  • Washington
    • Seattle, Washington, United States, 98104-2420
      • Harborview Medical Center /ID# 224464
    • Seattle, Washington, United States, 98101
      • Virginia Mason Hospital & Medical Center /ID# 224253
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospitals /ID# 223501

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Confirmed diagnosis of Crohn's disease (CD) for at least 3 months prior to Baseline.
• Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
• Confirmed diagnosis of moderate to severe Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
• Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies.

Exclusion Criteria:

• Current diagnosis of ulcerative colitis or indeterminate colitis.
• Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol).
• Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
• Currently know complications of CD (strictures, short bowel, etc).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risankizumab Dose A Followed by Dose B; Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous (SC) risankizumab dose B every 8 weeks through Week 48. Participants who complete the Week 48 visit will continue SC risankizumab for up to an additional 220 weeks.	Drug: Risankizumab; Intravenous (IV) Infusion; Other Names: ABBV-066; SKYRIZI; Drug: Risankizumab; Subcutaneous (SC) Injection; Other Names: ABBV-066; SKYRIZI
Active Comparator: Ustekinumab; Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.	Drug: Ustekinumab; Intravenous (IV) infusion; Drug: Ustekinumab; Subcutaneous (SC) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Remission at Week 24	Clinical remission is defined as Crohn's disease activity index (CDAI)<150.	Week 24
Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer.	Week 48
Number of Participants Reporting Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. 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 participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.	Up to 220 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Remission at Week 48	Clinical remission is defined as Crohn's disease activity index (CDAI)<150.	Week 48
Percentage of Participants Achieving Endoscopic Response at Week 48	Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).	Week 48
Percentage of Participants Achieving Endoscopic Response at Week 24	Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).	Week 24
Percentage of Participants Achieving Steroid-Free Endoscopic Remission	Steroid-free endoscopic remission is defined as participants with endoscopic remission and not receiving steroids at Week 48.	Week 48
Percentage of Participants Achieving Steroid-Free Clinical Remission	Steroid-free clinical remission is defined as participants with clinical remission and not receiving steroids at Week 48.	Week 48

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
• Peyrin-Biroulet L, Atreya R, Danese S, Lindsay JO, Chapman JC, Anschutz T, Huang X, Zambrano J, van Haaren S, Joshi N, Duan WR, Cross RK. Efficacy and safety of risankizumab in patients with moderately to severely active Crohn's disease: interim results from the SEQUENCE open-label extension study. J Crohns Colitis. 2025 Dec 23;19(12):jjaf213. doi: 10.1093/ecco-jcc/jjaf213.
• Peyrin-Biroulet L, Chapman JC, Colombel JF, Caprioli F, D'Haens G, Ferrante M, Schreiber S, Atreya R, Danese S, Lindsay JO, Bossuyt P, Siegmund B, Irving PM, Panaccione R, Cao Q, Neimark E, Wallace K, Anschutz T, Kligys K, Duan WR, Pivorunas V, Huang X, Berg S, Shu L, Dubinsky M; SEQUENCE Study Group. Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn's Disease. N Engl J Med. 2024 Jul 18;391(3):213-223. doi: 10.1056/NEJMoa2314585.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ustekinumab; Crohn's Disease (CD); Risankizumab; SKYRIZI
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ustekinumab; risankizumab
• Other Study ID Numbers: M20-259; 2020-002674-26 (EudraCT Number); 2022-501645-70-00 (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: No
• product manufactured in and exported from the U.S.: Yes