Overview

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

Status:
Recruiting
Trial end date:
2026-02-13
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Antibodies, Monoclonal
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