GRAVITI - A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease
Phase 1
- 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
- CTIS2023-504737-41-00
- Lead Sponsor
- Janssen - Cilag International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 510
Inclusion Criteria
Clinically active Crohn's disease or fistulizing Crohn's disease of at least 3 months duration, Endoscopic evidence of active ileocolonic Crohn's disease, Current treatment with oral corticosteroids and/or immunomodulators, OR history of failure to respond to or tolerate oral corticosteroids and/or immunomodulators, OR history of corticosteroid dependence, OR has previously demonstrated lack of initial response, lost response or were intolerant to 1 or more biologic agents.
Exclusion Criteria
Has a draining stoma or ostomy., Presence on screening endoscopy or history of adenomatous colonic polyps that were not removed., Has previously received a biologic agent targeting IL-12/23 or IL-23.
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