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Active Not Recruiting NCT04033445

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

Conditions: Ulcerative Colitis

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE2, PHASE3

Enrollment: 1064

Sponsor: Janssen Research & Development, LLC

Location: Om Research LLC Lancaster California

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 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 (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04033445). StuddyBuddy aggregates publicly available trial information.