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)

September 25, 2023 updated by: AbbVie

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

527

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 Univesitario /ID# 223433
    • Ciudad Autonoma De Buenos Aires
      • Ciudad Autonoma Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, 1199
        • Hospital Italiano de Buenos Aires /ID# 224550
      • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1027
        • CINME Centro de Investigaciones Metabolicas /ID# 223447
      • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1115
        • Gedyt /ID# 224698
      • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1280
        • Hospital Britanico de Buenos Aires /ID# 223432
      • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1431
        • Cemic /Id# 223670
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • 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 Medical Centre /ID# 224599
  • Austria
    • Niederoesterreich
      • Sankt Poelten, Niederoesterreich, Austria, 3100
        • Universitaetsklinikum St. Poelten /ID# 223437
    • Oberoesterreich
      • Linz, Oberoesterreich, Austria, 4010
        • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 223440
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universitaet Wien /ID# 223438
  • Belgium
      • Gent, Belgium, 9000
        • AZ Maria Middelares /ID# 223908
      • Liege, Belgium, 4000
        • CHU de Liege /ID# 223904
      • Liege, Belgium, 4000
        • Groupe Sante CHC - Clinique du MontLegia /ID# 223898
      • Merksem, Belgium, 2170
        • ZNA - Jan Palfijn /ID# 223907
      • Sint-Niklaas, Belgium, 9100
        • Vitaz /Id# 224511
    • Bruxelles-Capitale
      • Brussels, Bruxelles-Capitale, Belgium, 1070
        • Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 223902
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • UCL Saint-Luc /ID# 223900
    • Namur
      • Godinne, Namur, Belgium, 5530
        • CHU UCL Namur - site Godinne /ID# 223905
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 223899
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 223901
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • AZ-Delta /ID# 223896
  • Brazil
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-686
        • Upeclin Fmb - Unesp /Id# 223234
      • Ribeirão Preto, Sao Paulo, Brazil, 14051-140
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 223233
      • Santo André, Sao Paulo, Brazil, 09060-870
        • Faculdade de Medicina do ABC /ID# 223231
      • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
        • Kaiser Clinica e Hospital Dia /ID# 223232
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • UMHAT Kaspela EOOD /ID# 223415
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda University Hospital EAD /ID# 223757
      • Sofia, Bulgaria, 1527
        • UMHAT Tsaritsa Joanna - ISUL /ID# 223822
      • Sofia, Bulgaria, 1202
        • Second MHAT Sofia /ID# 223425
  • Canada
      • Montreal, Canada, H3G 1A4
        • Montreal General Hospital- McGill University Health Center /ID# 223743
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • 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 5W9
        • London Health Sciences Center- 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
      • Levis, Quebec, Canada, G6V 3Z1
        • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 223744
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHUS - Hopital Fleurimont /ID# 224819
  • Chile
      • Concepción, Chile, 4070038
        • Hospital Guillermo Grant Benavente de Concepción /ID# 223668
      • Talcahuano, Chile, 1740000
        • Hospital Las Higueras /ID# 223669
    • Region Metropolitana Santiago
      • Santiago, Region Metropolitana Santiago, Chile, 7500010
        • Sociedad de Servicios Medicos Walsen Galmez /ID# 224032
  • China
      • Changsha, China, 410011
        • The Second Xiangya Hospital of Central South University /ID# 224684
      • Shenyang, China, 110022
        • Shengjing Hospital of China Medical University /ID# 224478
    • Anhui
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital /ID# 224832
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital /ID# 224479
    • Chongqing
      • Chongqing, Chongqing, 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 Hosp Sun /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
        • The Third Xiangya Hospital of Central South University /ID# 224754
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • Changzhou No.2 People's 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
    • Shanghai
      • Shanghai, Shanghai, 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
      • Ceske Budejovice, Czechia, 370 01
        • Nemocnice Ceske Budejovice a.s. /ID# 224219
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterologie HK, s.r.o. /ID# 223277
      • Pardubice, Czechia, 530 03
        • Nemocnice Pardubickeho kraje, a.s. /ID# 223256
      • Praha, Czechia, 140 00
        • Axon Clinical, s.r.o. /ID# 223260
      • Praha, Czechia, 155 00
        • Nemocnice Horovice - NH Hospital a.s /ID# 223276
      • Praha, Czechia, 190 00
        • ISCARE a.s. /ID# 223279
  • France
      • La Tronche, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 224091
      • Nantes, France, 44300
        • Clinique Jules Verne /ID# 223870
      • Nimes Cedex, France, 30932
        • Polyclinique Grand Sud /ID# 224092
      • Toulouse, France, 31059
        • Hopital Universitaire Purpan Hopital Rangueil /ID# 224732
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06200
        • Chu de Nice-Hopital L'Archet Ii /Id# 223763
    • Auvergne-Rhone-Alpes
      • Clermont, Auvergne-Rhone-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
        • CHU Bordeaux - Hopital Haut Leveque /ID# 223764
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59037
        • CHRU Lille - Hopital Claude Huriez /ID# 223765
    • Herault
      • Montpellier Cedex 5, Herault, France, 34295
        • CHU Montpellier - Hôpital Saint Eloi /ID# 223860
    • Ile-de-France
      • Clichy, Ile-de-France, France, 92110
        • Hopital Beaujon /ID# 223863
      • Neuilly Sur Seine, Ile-de-France, France, 92200
        • Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249859
    • Loire
      • St. Priest En Jarez, Loire, France, 42270
        • CHU de SAINT ETIENNE - Hopital Nord /ID# 223768
    • Marne
      • Reims CEDEX, Marne, France, 51092
        • CHU Reims - Hôpital Robert Debre /ID# 224530
    • Meurthe-et-Moselle
      • Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
        • CHRU Nancy - Hopitaux de Brabois /ID# 223767
    • Pays-de-la-Loire
      • Nantes, Pays-de-la-Loire, France, 44000
        • CHU de Nantes, Hotel Dieu -HME /ID# 241098
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 223405
      • Berlin, Germany, 10318
        • Praxis Dr. Michael Mross /ID# 229110
      • Berlin, Germany, 10825
        • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 223411
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin Westend /ID# 223412
      • Berlin-Zehlendorf, Germany, 14163
        • Krankenhaus Waldfriede /ID# 223397
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 223403
      • Frankfurt am Main, Germany, 60431
        • Agaplesion Markus Krankenhaus /ID# 223673
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover /ID# 223402
      • Leipzig, Germany, 04103
        • EUGASTRO GmbH /ID# 223401
      • Lueneburg, Germany, 21339
        • Klinikum Lueneburg /ID# 223408
      • Magdeburg, Germany, 39120
        • Otto-von-Guericke-Universitaet /ID# 223413
      • Muenster, Germany, 48155
        • Medizinisches Versorgungszentrum Portal 10 /ID# 224552
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • Universitaetsklinikum Freiburg /ID# 223406
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • Universitatsklinikum Mannheim /ID# 223410
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • Universitaetsklinikum Ulm /ID# 223400
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Universitaetsklinikum Erlangen /ID# 223404
      • Ratisbon, Bayern, Germany, 93053
        • Universitatsklinik Regensburg /ID# 223407
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Universitaetsklinikum Frankfurt /ID# 223396
    • Nordrhein-Westfalen
      • Grevenbroich, Nordrhein-Westfalen, Germany, 41515
        • Praxiszentrum fuer Gastroenterologie /ID# 223409
    • Saarland
      • Saarbrücken, Saarland, Germany, 66111
        • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 223482
    • 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
      • Pireaus, Greece, 18454
        • General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 223340
      • Thessaloniki, Greece, 54642
        • General Hospital of Thessaloniki Hippokrateio /ID# 223887
    • Attiki
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Ippokratio /ID# 223344
      • Athens, Attiki, Greece, 11527
        • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 223342
    • Kriti
      • Heraklion, Kriti, 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
      • Szekszard, Hungary, 7100
        • Clinfan Szolgaltato Kft. /ID# 224751
    • Csongrad
      • Szeged, Csongrad, Hungary, 6725
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 223774
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont /ID# 223773
  • Israel
      • Holon, Israel, 5822000
        • The Edith Wolfson Medical Center /ID# 227652
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 223549
      • Petakh Tikva, Israel, 4941492
        • Rabin Medical Center /ID# 223558
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center /ID# 224686
    • HaDarom
      • Beer Sheva, HaDarom, 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-Yafo, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 223551
  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 223330
      • Cagliari, Italy, 09121
        • Azienda Ospedaliera G. Brotzu /ID# 241165
      • Cagliari, Italy, 09124
        • Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 223474
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 223324
      • Milano, Italy, 20157
        • ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 223322
      • Palermo, Italy, 90146
        • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 223333
    • Genova
      • Genoa, Genova, Italy, 16132
        • Ospedale Policlinico San Martino /ID# 223329
    • Lazio
      • Rome, Lazio, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini /ID# 223325
      • Rome, Lazio, Italy, 00168
        • Policlinico Agostino Gemelli /ID# 223323
    • Milano
      • Milan, Milano, Italy, 20132
        • Ospedale San Raffaele IRCCS /ID# 241167
      • 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
    • Verona
      • Negrar, Verona, Italy, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 223327
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital /ID# 223455
      • Daejeon, Korea, Republic of, 34943
        • The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 223453
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital /ID# 223452
  • Mexico
      • Veracruz, Mexico, 91900
        • Faicic S de Rl de Cv /Id# 226990
    • Baja California
      • Mexicali, Baja California, Mexico, 21200
        • Centro de Investigacion en Artritis y Osteoporosis S.C. /ID# 227179
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • BRCR Global México /ID# 223970
    • Nuevo Leon
      • San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278
        • Centro Medico Zambrano Hellion /ID# 224025
    • Yucatan
      • Mérida, Yucatan, Mexico, 97070
        • Medical Care & Research SA de CV /ID# 223974
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum /ID# 223228
      • Tilburg, Netherlands, 5022 GC
        • Elisabeth Tweesteden Ziekenhuis /ID# 223229
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht /ID# 223696
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboud Universitair Medisch Centrum /ID# 233750
  • Poland
    • Kujawsko-pomorskie
      • Torun, Kujawsko-pomorskie, Poland, 87-100
        • Gastromed Sp. z o.o /ID# 223705
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-149
        • Malopolskie Centrum Kliniczne /ID# 223708
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 03-580
        • NZOZ Vivamed Jadwiga Miecz /ID# 223706
  • Romania
      • Bucharest, Romania, 011025
        • Sana Monitoring /Id# 223682
      • Bucuresti, Romania, 020121
        • Spitalul Clinic Colentina /ID# 223680
      • Bucuresti, Romania, 050098
        • Univ Emergency Hosp Bucharest /ID# 223579
      • Targu Mures, Romania, 540136
        • Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 224017
      • Targu Mures, Romania, 540136
        • Targu Mures Emergency Clinical County Hospital /ID# 223613
      • Timișoara, Romania, 300002
        • Cabinet Particular Policlinic Algomed /ID# 223578
    • Bucuresti
      • Bucharest, Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni /ID# 223914
  • Russian Federation
      • Moscow, Russian Federation, 123423
        • National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 224222
      • St. Petersburg, Russian Federation, 197110
        • City Clinical Hospital No. 31 /ID# 224223
    • Kaliningradskaya Oblast
      • Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
        • Immanuel Kant Baltic Federal University /ID# 224224
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 223302
      • Nitra, Slovakia, 949 01
        • KM Management, spol. s.r.o. /ID# 223304
      • Nove Zamky, Slovakia, 940 34
        • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224580
      • Presov, Slovakia, 080 01
        • 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
  • 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, 28040
        • Hospital Clinico Universitario San Carlos /ID# 223367
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 223318
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena /ID# 223315
      • Sevilla, 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
        • Hospital Clínico Universitario de Santiago-CHUS /ID# 226554
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias /ID# 223368
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol /ID# 223436
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • 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
  • Sweden
      • Falun, Sweden, 791 31
        • Falu Lasarett /ID# 227222
      • Stockholm, Sweden, 182 88
        • Danderyds sjukhus AB /ID# 223363
    • Stockholms Lan
      • Solna, Stockholms Lan, Sweden, 171 64
        • Karolinska University Hospital Solna /ID# 223423
      • Stockholm, Stockholms Lan, Sweden, 114 28
        • GHP Stockholm Gastro Center /ID# 223420
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsspital Bern /ID# 223590
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • Universitätsspital Basel /ID# 223711
    • Zuerich
      • Zurich, Zuerich, Switzerland, 8091
        • Universitatsspital Zurich /ID# 223712
  • Turkey
      • Ankara, Turkey, 06590
        • Ankara Univ Medical Faculty /ID# 223388
      • Istanbul, Turkey, 34098
        • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 223387
      • Mersin, Turkey, 33343
        • Mersin University Medical /ID# 223385
    • Ankara
      • Yenimahalle, Ankara, Turkey, 06560
        • Gazi Universitesi Tip Fakultes /ID# 223386
  • Ukraine
      • Kyiv, Ukraine, 01030
        • Kyiv Municipal Clinical Hospital #18 /ID# 223700
      • Lviv, Ukraine, 79010
        • Lviv Regional Clinical Hospital /ID# 223661
      • Zaporizhzhia, Ukraine, 69076
        • Medical Center of LLC DIASERVIS /ID# 224249
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast Health and Social Care Trust /ID# 224023
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust /ID# 223648
      • Edinburgh, United Kingdom, EH3 9HE
        • NHS Lothian /ID# 223646
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter NHS Foundation Trust /ID# 223644
      • Huddersfield, United Kingdom, HX3 0PW
        • Calderdale and Huddersfield NHS Foundation Trust /ID# 223654
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust /ID# 223649
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • 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
      • Tooting, United Kingdom, SW17 0QT
        • St George's 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
    • London, City Of
      • London, London, City Of, United Kingdom, E1 2ES
        • Barts Health NHS Trust /ID# 223651
      • London, London, City Of, United Kingdom, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust /ID# 223647
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust /ID# 224179
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust /ID# 223645
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0XH
        • NHS Greater Glasgow and Clyde /ID# 223653
  • 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
        • UC Davis Medical Center /ID# 225700
      • San Francisco, California, United States, 94158
        • University of California, San Francisco /ID# 223621
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Western Connecticut Medical Group /ID# 223478
      • Hamden, Connecticut, United States, 06518
        • 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
        • 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
        • The University of Chicago DCAM /ID# 223520
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem /ID# 223538
      • Oak Lawn, Illinois, United States, 60453
        • Southwest Gastroenterology /ID# 223509
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville /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
        • 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
        • 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, 45267-0585
        • University of Cincinnati /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, 19610-2002
        • Digestive Disease Associates, LTD /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
        • DHAT Research Institute /ID# 223521
      • Houston, Texas, United States, 77017-2337
        • Vilo Research Group Inc /ID# 223513
      • Houston, Texas, United States, 77030-3411
        • 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, 75701-4464
        • 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
        • Hunter Holmes McGuire VA Medical Center /ID# 223586
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center /ID# 224253
      • Seattle, Washington, United States, 98104-2420
        • Harborview Medical Center /ID# 224464
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospitals /ID# 223501

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 78 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

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: Single

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
Time Frame: Week 24
Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
Week 24
Percentage of Participants Achieving Endoscopic Remission
Time Frame: Week 48
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
Time Frame: Up to 220 Weeks
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Week 48
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
Time Frame: Week 48
Steroid-free clinical remission is defined as participants with clinical remission and not receiving steroids at Week 48.
Week 48

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

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 30, 2020

Primary Completion (Estimated)

February 11, 2028

Study Completion (Estimated)

February 11, 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)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20-259
  • 2020-002674-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on 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

No

product manufactured in and exported from the U.S.

Yes

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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