Actively Recruiting
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
530
Participants Needed
11
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has Crohn's Disease or fistulizing Crohn's Disease for at least 12 weeks, confirmed by radiography, histology, or endoscopy
- Has moderately to severely active Crohn's Disease with a Crohn's Disease Activity Index (CDAI) score between 220 and 450
- Has baseline endoscopic evidence of active ileal and/or colonic Crohn's Disease with specific ulceration scores as assessed by central reading
- Investigator believes disease is appropriate for maintenance dosing regimens used in the study
- Will follow requirements for medications used to treat Crohn's Disease as outlined in the protocol
You will not qualify if you...
- Has complications like symptomatic strictures, stenoses, short gut syndrome, active draining stoma, significant fistulizing disease, or other issues expected to require surgery within a year
- Currently has or is suspected to have an abscess
- Has an active fistula at screening or Week 0 that may need surgery
- Had any bowel resection surgery within 24 weeks before the first study dose or major abdominal surgery within 12 weeks
- Has a current malignancy or had malignancy within 5 years before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Clinnova Research
Anaheim, California, United States, 92805
Actively Recruiting
2
TLC Clinical Research Inc
Los Angeles, California, United States, 90048
Actively Recruiting
3
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
4
Sanchez Clinical Research, Inc
Miami, Florida, United States, 33157-6575
Actively Recruiting
5
GCP Clinical Research
Tampa, Florida, United States, 33609
Actively Recruiting
6
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, United States, 66606
Actively Recruiting
7
New York Gastroenterology Associates
New York, New York, United States, 10075
Actively Recruiting
8
Southern Star Research Institute, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
9
GIRI Gastrointestinal Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
Actively Recruiting
10
London Digestive Disease Institute
London, Ontario, Canada, N6K 1M6
Actively Recruiting
11
Clinique IMD
Montreal, Quebec, Canada, H3H1E3
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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