A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
- Conditions
- Moderately to Severely Active Crohn's DiseaseMedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-504736-18-00
- Lead Sponsor
- Janssen - Cilag International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1102
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
- 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, - Any medical contraindications preventing study participation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method