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

• Status: Recruiting
• Trial end date: 2025-02-06
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.

Criteria

Inclusion Criteria:

• Have Crohn's Disease (CD) or fistulizing CD 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 components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence

• 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:

• Has complications of CD, 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 time frame as specified in the protocol

• Prior exposure to p40 inhibitors or p19 inhibitors

• Any medical contraindications preventing study participation