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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria:
* 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:
1. a minimum score of 1 for the component of "size of ulcers" AND
2. 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
Exclusion criteria
* Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab
* Currently has or is suspected to have an abscess
* Has an active fistula during screening or at Week 0 with an anticipated need for surgery
* Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention
* Currently has a malignancy or has a history of malignancy within 5 years before screening
Primary outcome measure(s)
Number of Participants with Deep Remission at Week 52 — At Week 52 Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as Crohn's Disease Activity Index (CDAI) score less than (\<) 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity. Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no sub score greater than (\>) 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.
Trial sites (160)
Facility
City
Region
Status
Digestive Health Specialists of the Southeast
Dothan
Alabama
Recruiting
East View Medical Research
Mobile
Alabama
Recruiting
Clinnova Research
Anaheim
California
Recruiting
Gastro Care Institute
Lancaster
California
Recruiting
United Gastroenterologists
Los Alamitos
California
Recruiting
TLC Clinical Research Inc
Los Angeles
California
Recruiting
GastroIntestinal Bioscience
Los Angeles
California
Recruiting
Hoag Memorial Hospital
Newport Beach
California
Suspended
Medical Associates Research Group, Inc.
San Diego
California
Recruiting
Peak Gastroenterology Associates
Colorado Springs
Colorado
Recruiting
Medical Research Center of Connecticut
Hamden
Connecticut
Recruiting
Green Leaf Clinical Trials
Jacksonville
Florida
Recruiting
Sanchez Clinical Research, Inc
Miami
Florida
Recruiting
Biodax Medical Research Trials
Miami
Florida
Recruiting
GI Pros Research
Naples
Florida
Recruiting
GCP Clinical Research
Tampa
Florida
Recruiting
Morehouse School of Medicine
Atlanta
Georgia
Recruiting
Atlanta Gastroenterology Associates
Atlanta
Georgia
Suspended
Gastroenterology Associates of Central GA
Macon
Georgia
Recruiting
Comprehensive Gastrointestinal Health Libertyville
Northbrook
Illinois
Suspended
Cotton-O'Neil Clinical Research Center
Topeka
Kansas
Recruiting
Gastroenterology Clinic of Acadiana
Lafayette
Louisiana
Recruiting
Woodholme Gastroenterology Associates
Glen Burnie
Maryland
Recruiting
Lucida Clinical Trials
New Bedford
Massachusetts
Recruiting
Michigan Center of Medical Research
Farmington Hills
Michigan
Recruiting
Westchester Putnam Gastroenterology
Carmel
New York
Recruiting
New York Gastroenterology Associates
New York
New York
Recruiting
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
Recruiting
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte
North Carolina
Recruiting
Great Lakes Gastroenterology Research, LLC
Mentor
Ohio
Recruiting
Digestive Disease Specialists Inc
Oklahoma City
Oklahoma
Recruiting
Frontier Clinical Research
Uniontown
Pennsylvania
Recruiting
Palmetto Primary and Specialty Care Physicians, Charleston
Summerville
South Carolina
Recruiting
DFW Clinical Trials
Carrollton
Texas
Recruiting
UT Southwestern
Dallas
Texas
Suspended
Lubbock Gastroenterology
Lubbock
Texas
Recruiting
Gastroenterology Research of America, LLC
San Antonio
Texas
Recruiting
Southern Star Research Institute, LLC
San Antonio
Texas
Recruiting
The University of Texas Health Science Center at Tyler
Tyler
Texas
Recruiting
LKH-Univ. Klinikum Graz
Graz
Austria
Recruiting
+ 120 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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