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