A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
• Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 but less than or equal to (\<=) 450
• Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) \>= 4 (for participants with isolated ileal disease) or \>= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:
‣ a minimum score of 1 for the component of size of ulcers AND
⁃ a minimum score of 1 for the component of ulcerated surface
• In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study
• Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol
Locations
United States
Alabama
Digestive Health Specialists of the Southeast
RECRUITING
Dothan
California
Clinnova Research
RECRUITING
Anaheim
United Gastroenterologists
RECRUITING
Los Alamitos
TLC Clinical Research Inc
RECRUITING
Los Angeles
Hoag Memorial Hospital
SUSPENDED
Newport Beach
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Florida
Sanchez Clinical Research, Inc
RECRUITING
Miami
GCP Clinical Research
RECRUITING
Tampa
Kansas
Cotton-O'Neil Clinical Research Center
RECRUITING
Topeka
North Carolina
Charlotte Gastroenterology and Hepatology, PLLC
RECRUITING
Charlotte
New York
Westchester Putnam Gastroenterology
RECRUITING
Carmel
New York Gastroenterology Associates
RECRUITING
New York
Ohio
Great Lakes Gastroenterology Research, LLC
RECRUITING
Mentor
Oklahoma
Digestive Disease Specialists Inc
RECRUITING
Oklahoma City
Pennsylvania
Frontier Clinical Research
RECRUITING
Uniontown
South Carolina
Palmetto Primary and Specialty Care Physicians, Charleston
RECRUITING
Summerville
Texas
Southern Star Research Institute, LLC
RECRUITING
San Antonio
Other Locations
Canada
London Digestive Disease Institute
RECRUITING
London
Clinique IMD
RECRUITING
Montreal
Taunton Surgical Centre
RECRUITING
Oshawa
Toronto Immune and Digestive Health Institute Inc
RECRUITING
Toronto
GIRI Gastrointestinal Research Institute
RECRUITING
Vancouver
China
The Sixth Affiliated Hospital Sun Yat sen University
Participants will receive guselkumab induction dose subcutaneously (SC) at Weeks 0, 4, and 8 followed by guselkumab maintenance dose SC once every 4 weeks (q4w) from Week 12 through Week 52.
Experimental: Risankizumab
Participants will receive risankizumab induction dose intravenously (IV) at Weeks 0, 4, and 8 followed by risankizumab maintenance dose SC once every 8 weeks (q8w) from Week 12 through Week 52.