Status:
ACTIVE_NOT_RECRUITING
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
Eligibility Criteria
Inclusion
- Documented diagnosis of ulcerative colitis (UC)
- Moderately to severely active UC, defined by modified Mayo score
- Demonstrated inadequate response or intolerance to medical therapies specified in the protocol
- Screening laboratory test results within the parameters specified in the protocol
Exclusion
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease
- UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon
- Presence of a stoma
- Presence or history of a fistula
- Receiving prohibited medications and/or treatment
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2027
Estimated Enrollment :
1064 Patients enrolled
Trial Details
Trial ID
NCT04033445
Start Date
September 26 2019
End Date
October 27 2027
Last Update
December 22 2025
Active Locations (391)
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1
Om Research LLC
Lancaster, California, United States, 93534
2
UCLA
Los Angeles, California, United States, 90095
3
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
4
Florida Research Network, LLC
Gainesville, Florida, United States, 32605