EUCTR2020-006165-11-DE
Active, not recruiting
Phase 1
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Moderately to Severely Active Crohn's Disease
- Sponsor
- Janssen-Cilag International NV
- Enrollment
- 350
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\- Clinically active Crohn’s disease or fistulizing Crohn’s disease of at least 3 months duration
- •2\- Endoscopic evidence of active ileocolonic Crohn's disease
- •4\- 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.
- •Please refer to protocol for the overall inclusion criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 274
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 76
Exclusion Criteria
- •1\-Has a draining stoma or ostomy.
- •2\- Presence on screening endoscopy or history of adenomatous colonic polyps that were not removed.
- •3\- Has previously received a biologic agent targeting IL\-12/23 or IL\-23\.
- •Please refer to protocol for the overall exclusion criteria
Outcomes
Primary Outcomes
Not specified
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