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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