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

• Status: Not yet recruiting
• Trial end date: 2026-01-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

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

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• 18 years of age or older

• Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening

• Moderately to severely active UC as per the modified Mayo score

• Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

• Signed informed consent form

Exclusion Criteria:

• Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease

• Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention

• Receiving prohibited medications and treatments

• UC limited to the rectum only

• Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection