EUCTR2013-002902-29-GBActive, not recruitingPhase 1
A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy.
Not provided0 sites120 target enrollmentStarted: November 26, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Men or women 18-75 years at the time of consent.
- •- Diagnosis of Crohn's disease at least 3 months prior to screening.
- •- Moderate to severe active Crohn's disease, defined as CDAI >or=220 and Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 119
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
Exclusion Criteria
- •- Complications of Crohn's disease such as strictures, stenoses, short gut syndrome, or any other manifestation that might require surgery.
- •- Presence of ileostomy or colostomy.
- •- Pregnant or nursing women.
- •- Signs or symptoms suggestive of active TB.
- •- History of malignancy.
Investigators
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