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Active Not Recruiting NCT05197049

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

Conditions: Crohn Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 350
Sponsor: Janssen Research & Development, LLC

Location: Digestive Health Specialists of the Southeast Dothan Alabama

Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Eligibility Criteria

Inclusion Criteria: * Diagnosis of Crohn's disease (CD) of at least 3 months in duration * Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD). * Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD Exclusion Criteria: * Current diagnosis of ulcerative colitis or indeterminate colitis * Complications of Crohn's disease that require surgical intervention or confound efficacy assessments * Unstable doses of concomitant Crohn's disease therapy

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05197049). StuddyBuddy aggregates publicly available trial information.