A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal; Ustekinumab

Criteria

Inclusion Criteria:

• Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy

• Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)

• Have screening laboratory test results within the protocol specified parameters

• A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline

• Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria:

• Current diagnosis of ulcerative colitis or indeterminate colitis

• Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation

• Unstable doses of concomitant Crohn's disease therapy

• Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol

• Prior exposure to p40 inhibitors or p19 inhibitors

• Any medical contraindications preventing study participation