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A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
Sponsor: AbbVie
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
289
Start Date
2023-11-15
Completion Date
2027-03
Last Updated
2025-09-09
Healthy Volunteers
No
Conditions
Interventions
Risankizumab SC
subcutaneous (SC) injection
Placebo for risankizumab
subcutaneous (SC) injection
Locations (179)
Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178
Sun City, Arizona, United States
Kindred Medical Institute - Corona /ID# 262075
Corona, California, United States
Southern California Res. Ctr. /ID# 256612
Coronado, California, United States
Valley Clinical Trials, LLC dba Flourish Research /ID# 256610
Covina, California, United States
Newport Huntington Medical Group /ID# 256622
Huntington Beach, California, United States
Om Research LLC /ID# 259645
Lancaster, California, United States
Om Research LLC /ID# 267523
Lancaster, California, United States
Clinnova Research - Orange /ID# 270138
Orange, California, United States
University of California, Irvine Medical Center /ID# 259677
Orange, California, United States
Prospective Research Innovations Inc. /ID# 267856
Rancho Cucamonga, California, United States
University of California San Francisco - Mission Bay /ID# 267529
San Francisco, California, United States
Amicis Research Center - Valencia /ID# 269158
Valencia, California, United States
OM Research LLC /ID# 268735
Victorville, California, United States
Danbury Hospital, Western Connecticut Health Network /ID# 261851
Danbury, Connecticut, United States
Novum Research /ID# 269223
Clermont, Florida, United States
Research Associates of South Florida, LLC /ID# 261627
Coral Gables, Florida, United States
University of Florida College of Medicine /ID# 261248
Gainesville, Florida, United States
Auzmer Research /ID# 261437
Lakeland, Florida, United States
Cfagi Llc /Id# 262005
Maitland, Florida, United States
Atlantic Medical Research /ID# 256471
Margate, Florida, United States
Homestead Associates in Research /ID# 259643
Miami, Florida, United States
University of Miami /ID# 256587
Miami, Florida, United States
JD Medical Group, LLC /ID# 262185
Miami, Florida, United States
Gastroenterology Group Naples /ID# 256566
Naples, Florida, United States
Sarkis Clinical Trials - Ocala /ID# 267840
Ocala, Florida, United States
Endoscopic Research, Inc. /ID# 256597
Orlando, Florida, United States
AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 261811
Orlando, Florida, United States
GCP Clinical Research, LLC /ID# 260342
Tampa, Florida, United States
Avita Clinical Research /ID# 261640
Tampa, Florida, United States
Winship Cancer Institute of Emory University /ID# 261877
Atlanta, Georgia, United States
Mount Vernon Clinical Research /ID# 271813
Atlanta, Georgia, United States
Atlanta Ctr. for Gastro /ID# 261181
Decatur, Georgia, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 256611
Macon, Georgia, United States
Gastroenterology Consultants, P.C /ID# 260635
Roswell, Georgia, United States
Grand Teton Research Group /ID# 267521
Idaho Falls, Idaho, United States
Duplicate_The University of Chicago DCAM /ID# 256577
Chicago, Illinois, United States
GI Alliance - Glenview /ID# 257744
Glenview, Illinois, United States
GI Alliance - Gurnee /ID# 257735
Gurnee, Illinois, United States
Southwest Gastroenterology /ID# 256619
Oak Lawn, Illinois, United States
IU Health University Hospital /ID# 259633
Indianapolis, Indiana, United States
Univ Kansas Med Ctr /ID# 262551
Kansas City, Kansas, United States
Cotton O'Neil Clinical Research Center, Digestive Health /ID# 256592
Topeka, Kansas, United States
University of Louisville Hospital /ID# 256569
Louisville, Kentucky, United States
Louisiana Research Center, LLC /ID# 256598
Shreveport, Louisiana, United States
Portland Gastroenterology Center - Portland - Congress Street /ID# 268428
Portland, Maine, United States
Massachusetts General Hospital /Id# 261051
Boston, Massachusetts, United States
Clin Res Inst of Michigan, LLC /ID# 256609
Chesterfield, Michigan, United States
Clin Res Inst of Michigan, LLC /ID# 261017
Chesterfield, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 256568
Wyoming, Michigan, United States
Mayo Clinic - Rochester /ID# 256594
Rochester, Minnesota, United States
Saint Lukes Hospital of Kansas City /ID# 271816
Kansas City, Missouri, United States
Allied Health Clinical Research Organization, LLC /ID# 261618
Englewood, New Jersey, United States
NY Scientific /ID# 261209
Brooklyn, New York, United States
Columbia University Medical Center /ID# 261879
New York, New York, United States
New York Gastroenterology Associates /ID# 257730
New York, New York, United States
Univ NC Chapel Hill /ID# 256368
Chapel Hill, North Carolina, United States
Carolina Research /ID# 261435
Greenville, North Carolina, United States
Boice-Willis Clinic, P.A. /ID# 262209
Rocky Mount, North Carolina, United States
Plains Clinical Research Center, LLC /ID# 256602
Fargo, North Dakota, United States
Optimed Research, Ltd. /ID# 256573
Columbus, Ohio, United States
The Ohio State University - Hilliard /ID# 256623
Hilliard, Ohio, United States
Hightower Clinical /ID# 256613
Oklahoma City, Oklahoma, United States
Options Health Research /ID# 271243
Tulsa, Oklahoma, United States
Gastro One /ID# 256614
Cordova, Tennessee, United States
Quality Medical Research /ID# 262077
Nashville, Tennessee, United States
Amel Med LLC. /ID# 259642
Austin, Texas, United States
Novel Research - Bellaire /ID# 269788
Bellaire, Texas, United States
University of Texas - Southwestern Medical Center /ID# 268157
Dallas, Texas, United States
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 256596
Garland, Texas, United States
Baylor College of Medicine /ID# 256600
Houston, Texas, United States
LinQ Research /ID# 267880
Houston, Texas, United States
GI Alliance/TDDC /ID# 261623
Lubbock, Texas, United States
North Hills Medical Research - North Richard Hills /ID# 268411
North Richland Hills, Texas, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 256599
San Antonio, Texas, United States
Southern Star Research Institute, LLC /ID# 256601
San Antonio, Texas, United States
Tyler Research Institute, LLC /ID# 256595
Tyler, Texas, United States
GI Alliance Bay Area Gastroenterology /ID# 261866
Webster, Texas, United States
University Physicians and Surgeons Inc. /ID# 259636
Huntington, West Virginia, United States
Wisconsin Center for Advanced Research /ID# 256575
Milwaukee, Wisconsin, United States
Hospital Britanico de Buenos Aires /ID# 256011
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Gedyt /ID# 258984
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 256690
Córdoba, Argentina
L2ip - Instituto De Pesquisas Clínicas /ID# 261491
Brasília, Federal District, Brazil
Galileo Medical Research Ltda /ID# 261493
Juiz de Fora, Minas Gerais, Brazil
Hospital de Clinicas de Porto Alegre /ID# 261496
Porto Alegre, Rio Grande do Sul, Brazil
Upeclin Fmb - Unesp /Id# 261490
Botucatu, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 261489
Ribeirão Preto, São Paulo, Brazil
Rocco & Nazato Servicos Medicos /ID# 261497
São Paulo, São Paulo, Brazil
University of Calgary /ID# 264640
Calgary, Alberta, Canada
Allen Whey Khye Lim Professional Corporation /ID# 261155
Edmonton, Alberta, Canada
Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 257072
Halifax, Nova Scotia, Canada
Toronto Digestive Disease Associates /ID# 260532
Vaughan, Ontario, Canada
Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 262179
Montreal, Quebec, Canada
Hospital Guillermo Grant Benavente de Concepción /ID# 256398
Concepción, Bio-Bio, Chile
Sociedad de Servicios Medicos Walsen Galmez Ltda. /ID# 256397
Providencia, Region Metropolitana Santiago, Chile
Centros Medicos Espacioeme Spa /Id# 262844
Santiago, Region Metropolitana Santiago, Chile
Pontificia Universidad Catolica de Chile /ID# 256935
Santiago, Region Metropolitana Santiago, Chile
Serv Salud Metropolitano Central Hospital Clinico San Borja Arriaran /Id# 260765
Santiago, Region Metropolitana Santiago, Chile
Clinica Dermacross /ID# 260769
Vitacura, Region Metropolitana Santiago, Chile
Hospital Clinico Universidad De Los Andes /ID# 256856
Santiago, Chile
Chongqing General Hospital /ID# 260941
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University /ID# 260944
Xiamen, Fujian, China
Guangzhou First People's Hospital /ID# 260943
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 260248
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 260247
Guangzhou, Guangdong, China
Renmin Hospital of Wuhan University /ID# 261281
Wuhan, Hubei, China
The Second Xiangya Hospital Of Central South University /ID# 260938
Changsha, Hunan, China
Changzhou No.2 Peoples Hospital /ID# 260935
Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital /ID# 260942
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University /ID# 260934
Nanjing, Jiangsu, China
Wuxi PeopleS Hospital /ID# 270166
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 260936
Nanchang, Jiangxi, China
Renji Hospital, Shanghai Jiaotong University School Of Medicine /ID# 270165
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260251
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 260246
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Henan University of Science and Technology /ID# 260933
Luoyang, China
Fakultni Thomayerova nemocnice /ID# 272944
Prague, Praha 4, Czechia
Nemocnice Ceske Budejovice a.s. /ID# 256414
České Budějovice, Czechia
Duplicate_Clinfan Szolgaltato Kft. /ID# 260032
Szekszárd, Tolna County, Hungary
Semmelweis Egyetem /ID# 260030
Budapest, Hungary
Semmelweis Egyetem /ID# 274289
Budapest, Hungary
Shaare Zedek Medical Center /ID# 256253
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 256251
Ramat Gan, Tel Aviv, Israel
Bnai Zion Medical Center /ID# 264457
Haifa, Israel
Gamagori City Hospital /ID# 261372
Gamagori-shi, Aichi-ken, Japan
Tsujinaka Hospital - Kashiwanoha /ID# 261370
Kashiwa-shi, Chiba, Japan
Hyogo Medical University Hospital /ID# 261371
Nishinomiya-shi, Hyōgo, Japan
Hamamatsu University Hospital /ID# 268612
Hamamatsu, Shizuoka, Japan
NHO Shizuoka Medical Center /ID# 261373
Sunto-gun, Shizuoka, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 269630
Kaunas, Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 269628
Vilnius, Lithuania
CenterMed Krakow Sp. z o.o. /ID# 273038
Krakow, Lesser Poland Voivodeship, Poland
Panstwowy Instytut Medyczny MSWiA /ID# 273024
Warsaw, Masovian Voivodeship, Poland
WSD MEDI Clinical Sp. z o.o. /ID# 273053
Warsaw, Masovian Voivodeship, Poland
Caribbean Medical Research Center /ID# 268398
San Juan, Puerto Rico
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 262250
San Juan, Puerto Rico
King Fahad Specialist Hospital /ID# 264441
Dammam, Saudi Arabia
King Abdulaziz Medical City- National Guard Hospital /ID# 264542
Riyadh, Saudi Arabia
King Saud University /ID# 264536
Riyadh, Saudi Arabia
King Faisal Specialist Hospital and Research Center /ID# 264539
Riyadh, Saudi Arabia
Clinical Hosp Center Zvezdara /ID# 256727
Belgrade, Beograd, Serbia
University Clinical Center Serbia /ID# 256904
Belgrade, Beograd, Serbia
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 256844
Belgrade, Beograd, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 257899
Belgrade, Beograd, Serbia
General Hospital Leskovac /ID# 261812
Leskovac, Jablanicki Okrug, Serbia
Opsta Bolnica Pancevo /ID# 266881
Pančevo, Vojvodina, Serbia
University Clinical Center Vojvodina /ID# 256843
Novi Sad, Serbia
Inje University Haeundae Paik Hospital /ID# 268081
Busan, Busan Gwang Yeogsi, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 259257
Daejeon, Daejeon Gwang Yeogsi, South Korea
The Catholic University Of Korea St. Vincent's Hospital /ID# 268080
Suwon, Gyeonggido, South Korea
Kangbuk Samsung Hospital /ID# 262248
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 259255
Seoul, Seoul Teugbyeolsi, South Korea
Gangnam Severance Hospital /ID# 270780
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 259254
Seoul, Seoul Teugbyeolsi, South Korea
Kyungpook National University Chilgok Hospital /ID# 262449
Daegu, South Korea
Yonsei University Health System Severance Hospital /ID# 259256
Seoul, South Korea
National Taiwan University Hospital /ID# 256891
Taipei City, Taipei, Taiwan
Show Chwan Memorial Hospital /ID# 272483
Changhua, Taiwan
Chiayi Chang Gung Memorial Hospital /ID# 272484
Chiayi City, Taiwan
Far Eastern Memorial Hospital /ID# 256893
New Taipei City, Taiwan
China Medical University Hospital /ID# 256890
Taichung, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 256892
Taoyuan, Taiwan
Gazi Universitesi Tip Fakultes /ID# 259747
Yenimahalle, Ankara, Turkey (Türkiye)
Kocaeli University Research and Application Hospital /ID# 259750
Dilovası, Kocaeli, Turkey (Türkiye)
Ankara City Hospital /ID# 261906
Ankara, Turkey (Türkiye)
Antalya Egitim Ve Arastirma Hastanesi /ID# 259746
Antalya, Turkey (Türkiye)
Ege University Medical Faculty /ID# 259749
Izmir, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty /ID# 262041
Izmir, Turkey (Türkiye)
Mersin University Medical /ID# 259748
Mersin, Turkey (Türkiye)
Burjeel Medical City /ID# 269671
Abu Dhabi, United Arab Emirates
Sheikh Shakhbout Medical City /ID# 269680
Abu Dhabi, United Arab Emirates
Velocity Clinical Research Ltd /ID# 271687
High Wycombe, Buckinghamshire, United Kingdom
Addenbrookes Hospital /ID# 256735
Cambridge, Cambridgeshire, United Kingdom
St George University Hospitals NHS Foundation Trust /ID# 256729
London, Greater London, United Kingdom
Velocity North London /ID# 271900
North Finchley, Greater London, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 256738
Birmingham, United Kingdom
The Dudley Group NHS Foundation Trust /ID# 258681
Dudley, United Kingdom
Whiston Hospital /ID# 261449
Prescot, United Kingdom
Stepping Hill Hospital /ID# 259867
Stockport, United Kingdom