Status:
ACTIVE_NOT_RECRUITING
A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
Eligibility Criteria
Inclusion
- Diagnosis of Crohn's disease (CD) of at least 3 months in duration
- Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
- Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Exclusion
- Current diagnosis of ulcerative colitis or indeterminate colitis
- Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
- Unstable doses of concomitant Crohn's disease therapy
Key Trial Info
Start Date :
January 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2028
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT05197049
Start Date
January 19 2022
End Date
October 30 2028
Last Update
December 23 2025
Active Locations (344)
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1
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States, 36305
2
Advanced Gastro P.C
Chandler, Arizona, United States, 85224-1636
3
Reliance Research
Scottsdale, Arizona, United States, 85260
4
Moore Clinical Trials, LLC
Little Rock, Arkansas, United States, 72205-6414