A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. (AFFIRM)

September 8, 2025 updated by: AbbVie

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects With Moderately to Severely Active Crohn's Disease

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants.

Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally.

Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

289

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
      • Córdoba, Argentina, 5016
        • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 256690
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, 1280
        • Hospital Britanico de Buenos Aires /ID# 256011
    • Buenos Aires F.D.
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1115
        • Gedyt /ID# 258984
  • Brazil
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • L2ip - Instituto De Pesquisas Clínicas /ID# 261491
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36033-318
        • Galileo Medical Research Ltda /ID# 261493
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre /ID# 261496
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-686
        • Upeclin Fmb - Unesp /Id# 261490
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 261489
      • São Paulo, São Paulo, Brazil, 04543-011
        • Rocco & Nazato Servicos Medicos /ID# 261497
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary /ID# 264640
      • Edmonton, Alberta, Canada, T5R 1W2
        • Allen Whey Khye Lim Professional Corporation /ID# 261155
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 257072
    • Ontario
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates /ID# 260532
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 262179
  • Chile
      • Santiago, Chile, 7501504
        • Hospital Clinico Universidad De Los Andes /ID# 256856
    • Bio-Bio
      • Concepción, Bio-Bio, Chile, 4070038
        • Hospital Guillermo Grant Benavente de Concepción /ID# 256398
    • Region Metropolitana Santiago
      • Providencia, Region Metropolitana Santiago, Chile, 7510086
        • Sociedad de Servicios Medicos Walsen Galmez Ltda. /ID# 256397
      • Santiago, Region Metropolitana Santiago, Chile, 7770086
        • Centros Medicos Espacioeme Spa /Id# 262844
      • Santiago, Region Metropolitana Santiago, Chile, 8331150
        • Pontificia Universidad Catolica de Chile /ID# 256935
      • Santiago, Region Metropolitana Santiago, Chile, 8360156
        • Serv Salud Metropolitano Central Hospital Clinico San Borja Arriaran /Id# 260765
      • Vitacura, Region Metropolitana Santiago, Chile, 7640881
        • Clinica Dermacross /ID# 260769
  • China
      • Luoyang, China, 471000
        • The First Affiliated Hospital of Henan University of Science and Technology /ID# 260933
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400013
        • Chongqing General Hospital /ID# 260941
    • Fujian
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University /ID# 260944
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First People's Hospital /ID# 260943
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University /ID# 260248
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 260247
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University /ID# 261281
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital Of Central South University /ID# 260938
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • Changzhou No.2 Peoples Hospital /ID# 260935
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital /ID# 260942
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital Southeast University /ID# 260934
      • Wuxi, Jiangsu, China, 214023
        • Wuxi PeopleS Hospital /ID# 270166
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University /ID# 260936
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Renji Hospital, Shanghai Jiaotong University School Of Medicine /ID# 270165
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260251
      • Hangzhou, Zhejiang, China, 310018
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 260246
  • Czechia
      • České Budějovice, Czechia, 370 01
        • Nemocnice Ceske Budejovice a.s. /ID# 256414
    • Praha 4
      • Prague, Praha 4, Czechia, 140 00
        • Fakultni Thomayerova nemocnice /ID# 272944
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 260030
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 274289
    • Tolna County
      • Szekszárd, Tolna County, Hungary, 7100
        • Duplicate_Clinfan Szolgaltato Kft. /ID# 260032
  • Israel
      • Haifa, Israel, 3104802
        • Bnai Zion Medical Center /ID# 264457
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 256253
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 256251
  • Japan
    • Aichi-ken
      • Gamagori-shi, Aichi-ken, Japan, 443-8501
        • Gamagori City Hospital /ID# 261372
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-0871
        • Tsujinaka Hospital - Kashiwanoha /ID# 261370
    • Hyōgo
      • Nishinomiya-shi, Hyōgo, Japan, 663-8501
        • Hyogo Medical University Hospital /ID# 261371
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital /ID# 268612
      • Sunto-gun, Shizuoka, Japan, 411-8611
        • NHO Shizuoka Medical Center /ID# 261373
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 269630
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santaros Klinikos /ID# 269628
  • Poland
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-530
        • CenterMed Krakow Sp. z o.o. /ID# 273038
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • Panstwowy Instytut Medyczny MSWiA /ID# 273024
      • Warsaw, Masovian Voivodeship, Poland, 02-786
        • WSD MEDI Clinical Sp. z o.o. /ID# 273053
  • Puerto Rico
      • San Juan, Puerto Rico, 00918-3501
        • Caribbean Medical Research Center /ID# 268398
      • San Juan, Puerto Rico, 00935
        • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 262250
  • Saudi Arabia
      • Dammam, Saudi Arabia, 32253
        • King Fahad Specialist Hospital /ID# 264441
      • Riyadh, Saudi Arabia, 11426
        • King Abdulaziz Medical City- National Guard Hospital /ID# 264542
      • Riyadh, Saudi Arabia, 12372
        • King Saud University /ID# 264536
      • Riyadh, Saudi Arabia, 12713
        • King Faisal Specialist Hospital and Research Center /ID# 264539
  • Serbia
      • Novi Sad, Serbia, 21000
        • University Clinical Center Vojvodina /ID# 256843
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Clinical Hosp Center Zvezdara /ID# 256727
      • Belgrade, Beograd, Serbia, 11000
        • University Clinical Center Serbia /ID# 256904
      • Belgrade, Beograd, Serbia, 11040
        • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 256844
      • Belgrade, Beograd, Serbia, 11080
        • Clin Hosp Ctr Bezanijska Kosa /ID# 257899
    • Jablanicki Okrug
      • Leskovac, Jablanicki Okrug, Serbia, 16000
        • General Hospital Leskovac /ID# 261812
    • Vojvodina
      • Pančevo, Vojvodina, Serbia, 26101
        • Opsta Bolnica Pancevo /ID# 266881
  • South Korea
      • Daegu, South Korea, 41404
        • Kyungpook National University Chilgok Hospital /ID# 262449
      • Seoul, South Korea, 03722
        • Yonsei University Health System Severance Hospital /ID# 259256
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 48108
        • Inje University Haeundae Paik Hospital /ID# 268081
    • Daejeon Gwang Yeogsi
      • Daejeon, Daejeon Gwang Yeogsi, South Korea, 34943
        • The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 259257
    • Gyeonggido
      • Suwon, Gyeonggido, South Korea, 16247
        • The Catholic University Of Korea St. Vincent's Hospital /ID# 268080
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03181
        • Kangbuk Samsung Hospital /ID# 262248
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center /ID# 259255
      • Seoul, Seoul Teugbyeolsi, South Korea, 06273
        • Gangnam Severance Hospital /ID# 270780
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center /ID# 259254
  • Taiwan
      • Changhua, Taiwan, 500
        • Show Chwan Memorial Hospital /ID# 272483
      • Chiayi City, Taiwan, 613
        • Chiayi Chang Gung Memorial Hospital /ID# 272484
      • New Taipei City, Taiwan, 22060
        • Far Eastern Memorial Hospital /ID# 256893
      • Taichung, Taiwan, 40447
        • China Medical University Hospital /ID# 256890
      • Taoyuan, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital /ID# 256892
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 256891
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06800
        • Ankara City Hospital /ID# 261906
      • Antalya, Turkey (Türkiye), 07100
        • Antalya Egitim Ve Arastirma Hastanesi /ID# 259746
      • Izmir, Turkey (Türkiye), 35040
        • Ege University Medical Faculty /ID# 259749
      • Izmir, Turkey (Türkiye), 35340
        • Dokuz Eylul University Medical Faculty /ID# 262041
      • Mersin, Turkey (Türkiye), 33343
        • Mersin University Medical /ID# 259748
    • Ankara
      • Yenimahalle, Ankara, Turkey (Türkiye), 06560
        • Gazi Universitesi Tip Fakultes /ID# 259747
    • Kocaeli
      • Dilovası, Kocaeli, Turkey (Türkiye), 41455
        • Kocaeli University Research and Application Hospital /ID# 259750
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Burjeel Medical City /ID# 269671
      • Abu Dhabi, United Arab Emirates, 11001
        • Sheikh Shakhbout Medical City /ID# 269680
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust /ID# 256738
      • Dudley, United Kingdom, DY1 2HQ
        • The Dudley Group NHS Foundation Trust /ID# 258681
      • Prescot, United Kingdom, L35 5DR
        • Whiston Hospital /ID# 261449
      • Stockport, United Kingdom, SK2 7JE
        • Stepping Hill Hospital /ID# 259867
    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2QW
        • Velocity Clinical Research Ltd /ID# 271687
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Addenbrookes Hospital /ID# 256735
    • Greater London
      • London, Greater London, United Kingdom, SW17 0QT
        • St George University Hospitals NHS Foundation Trust /ID# 256729
      • North Finchley, Greater London, United Kingdom, N12 8BU
        • Velocity North London /ID# 271900
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178
    • California
      • Corona, California, United States, 92879-3104
        • Kindred Medical Institute - Corona /ID# 262075
      • Coronado, California, United States, 92118-1408
        • Southern California Res. Ctr. /ID# 256612
      • Covina, California, United States, 91723
        • Valley Clinical Trials, LLC dba Flourish Research /ID# 256610
      • Huntington Beach, California, United States, 92648-5994
        • Newport Huntington Medical Group /ID# 256622
      • Lancaster, California, United States, 93534
        • Om Research LLC /ID# 259645
      • Lancaster, California, United States, 93534
        • Om Research LLC /ID# 267523
      • Orange, California, United States, 92868
        • Clinnova Research - Orange /ID# 270138
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center /ID# 259677
      • Rancho Cucamonga, California, United States, 91730
        • Prospective Research Innovations Inc. /ID# 267856
      • San Francisco, California, United States, 94158
        • University of California San Francisco - Mission Bay /ID# 267529
      • Valencia, California, United States, 91355
        • Amicis Research Center - Valencia /ID# 269158
      • Victorville, California, United States, 92395
        • OM Research LLC /ID# 268735
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital, Western Connecticut Health Network /ID# 261851
    • Florida
      • Clermont, Florida, United States, 34711
        • Novum Research /ID# 269223
      • Coral Gables, Florida, United States, 33134-2442
        • Research Associates of South Florida, LLC /ID# 261627
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Medicine /ID# 261248
      • Lakeland, Florida, United States, 33813-4924
        • Auzmer Research /ID# 261437
      • Maitland, Florida, United States, 32751-6108
        • Cfagi Llc /Id# 262005
      • Margate, Florida, United States, 33063-5737
        • Atlantic Medical Research /ID# 256471
      • Miami, Florida, United States, 33032
        • Homestead Associates in Research /ID# 259643
      • Miami, Florida, United States, 33136
        • University of Miami /ID# 256587
      • Miami, Florida, United States, 33176-2302
        • JD Medical Group, LLC /ID# 262185
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Naples /ID# 256566
      • Ocala, Florida, United States, 34474
        • Sarkis Clinical Trials - Ocala /ID# 267840
      • Orlando, Florida, United States, 32803
        • Endoscopic Research, Inc. /ID# 256597
      • Orlando, Florida, United States, 32804-5505
        • AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 261811
      • Tampa, Florida, United States, 33609
        • GCP Clinical Research, LLC /ID# 260342
      • Tampa, Florida, United States, 33613-1825
        • Avita Clinical Research /ID# 261640
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University /ID# 261877
      • Atlanta, Georgia, United States, 30328
        • Mount Vernon Clinical Research /ID# 271813
      • Decatur, Georgia, United States, 30033
        • Atlanta Ctr. for Gastro /ID# 261181
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia, LLC /ID# 256611
      • Roswell, Georgia, United States, 30076-4913
        • Gastroenterology Consultants, P.C /ID# 260635
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Research Group /ID# 267521
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Duplicate_The University of Chicago DCAM /ID# 256577
      • Glenview, Illinois, United States, 60026-8000
        • GI Alliance - Glenview /ID# 257744
      • Gurnee, Illinois, United States, 60031-5711
        • GI Alliance - Gurnee /ID# 257735
      • Oak Lawn, Illinois, United States, 60453
        • Southwest Gastroenterology /ID# 256619
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5149
        • IU Health University Hospital /ID# 259633
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Univ Kansas Med Ctr /ID# 262551
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center, Digestive Health /ID# 256592
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital /ID# 256569
    • Louisiana
      • Shreveport, Louisiana, United States, 71105-6800
        • Louisiana Research Center, LLC /ID# 256598
    • Maine
      • Portland, Maine, United States, 04102
        • Portland Gastroenterology Center - Portland - Congress Street /ID# 268428
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital /Id# 261051
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clin Res Inst of Michigan, LLC /ID# 256609
      • Chesterfield, Michigan, United States, 48047
        • Clin Res Inst of Michigan, LLC /ID# 261017
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 256568
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - Rochester /ID# 256594
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Lukes Hospital of Kansas City /ID# 271816
    • New Jersey
      • Englewood, New Jersey, United States, 07631-4152
        • Allied Health Clinical Research Organization, LLC /ID# 261618
    • New York
      • Brooklyn, New York, United States, 11235-3919
        • NY Scientific /ID# 261209
      • New York, New York, United States, 10032-3729
        • Columbia University Medical Center /ID# 261879
      • New York, New York, United States, 10075
        • New York Gastroenterology Associates /ID# 257730
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514-4220
        • Univ NC Chapel Hill /ID# 256368
      • Greenville, North Carolina, United States, 27834
        • Carolina Research /ID# 261435
      • Rocky Mount, North Carolina, United States, 27804
        • Boice-Willis Clinic, P.A. /ID# 262209
    • North Dakota
      • Fargo, North Dakota, United States, 58104-5925
        • Plains Clinical Research Center, LLC /ID# 256602
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Optimed Research, Ltd. /ID# 256573
      • Hilliard, Ohio, United States, 43210
        • The Ohio State University - Hilliard /ID# 256623
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Hightower Clinical /ID# 256613
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research /ID# 271243
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Gastro One /ID# 256614
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research /ID# 262077
    • Texas
      • Austin, Texas, United States, 78705
        • Amel Med LLC. /ID# 259642
      • Bellaire, Texas, United States, 77401
        • Novel Research - Bellaire /ID# 269788
      • Dallas, Texas, United States, 75235
        • University of Texas - Southwestern Medical Center /ID# 268157
      • Garland, Texas, United States, 75044
        • Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 256596
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine /ID# 256600
      • Houston, Texas, United States, 77087
        • LinQ Research /ID# 267880
      • Lubbock, Texas, United States, 79410-2014
        • GI Alliance/TDDC /ID# 261623
      • North Richland Hills, Texas, United States, 76180
        • North Hills Medical Research - North Richard Hills /ID# 268411
      • San Antonio, Texas, United States, 78212
        • Clinical Associates in Research Therapeutics of America, LLC /ID# 256599
      • San Antonio, Texas, United States, 78229-5390
        • Southern Star Research Institute, LLC /ID# 256601
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute, LLC /ID# 256595
      • Webster, Texas, United States, 77598-4052
        • GI Alliance Bay Area Gastroenterology /ID# 261866
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • University Physicians and Surgeons Inc. /ID# 259636
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Center for Advanced Research /ID# 256575

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

No

Description

Inclusion Criteria:

  • Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.

  • Participant meets the following disease activity criteria:

    1. Moderate to severe CD as assessed by CDAI
    2. Endoscopic evidence of mucosal inflammation as documented by a SES-CD
  • Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.

Exclusion Criteria:

  • Participants with a current diagnosis of ulcerative colitis or indeterminate colitis.
  • Participants with unstable doses of concomitant Crohn's disease therapy.
  • Participants with prior exposure to p19 inhibitors.
  • Participants with complications of Crohn's disease.
  • Participants having an ostomy or ileoanal pouch.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Period A: Risankizumab Dose A
Participants randomized to receive risankizumab Dose A administered by subcutaneous (SC) injection for up to 12 weeks during Period A.
Drug: Risankizumab SC
subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • SKYRIZI
Placebo Comparator: Period A: Placebo
Participants randomized to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks during Period A.
Drug: Placebo for risankizumab
subcutaneous (SC) injection
Experimental: Period B: Risankizumab Dose B
Participants randomized to receive risankizumab Dose A in Period A that achieved adequate response to receive risankizumab Dose B administered by subcutaneous (SC) injection for up to 12 weeks.
Drug: Risankizumab SC
subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • SKYRIZI
Placebo Comparator: Period B: Placebo
Participants randomized to receive placebo risankizumab in Period A that achieved adequate response to continue to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks in Period B.
Drug: Placebo for risankizumab
subcutaneous (SC) injection
Experimental: Period B: Risankizumab Dose C
Participants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 12 weeks during Period B.
Drug: Risankizumab SC
subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • SKYRIZI
Experimental: Period C: Open-Label Risankizumab Dose D
Participants who complete the Period B Week 24 visit to receive open-label risankizumab Dose D administered by subcutaneous (SC) injection for up to 52 weeks during Period C.
Drug: Risankizumab SC
subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • SKYRIZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150)
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 Endoscopic Response
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 response is defined as a decrease in 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 12
Number of Participants Experiencing Adverse Events
Time Frame: Up to approximately 96 weeks
An 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.
Up to approximately 96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical Remission
Time Frame: Week 12
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Week 12
Percentage of Participants With Endoscopic Remission
Time Frame: Week 12
Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Week 12
Percentage of Participants With Ulcer-Free Endoscopy
Time Frame: Week 12
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Week 12
Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Time Frame: Week 12
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a 5-point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Week 12
Percentage of Participants with a CR-100 Clinical Response
Time Frame: Week 4
CR-100 defined as at least a 100-point reduction from Baseline in CDAI
Week 4

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)

November 15, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M23-784
  • 2024-516023-13-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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