A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

• Status: Recruiting
• Trial end date: 2029-09-29
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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