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Active Not Recruiting
NCT05528510
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Conditions: Colitis, Ulcerative
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 418
Sponsor: Janssen Research & Development, LLC
Location: Research Solutions of Arizona Litchfield Park Arizona
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).
Eligibility Criteria
Inclusion Criteria:
* Signed informed consent form
* 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
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
Source: ClinicalTrials.gov (NCT05528510). StuddyBuddy aggregates publicly available trial information.