EUCTR2013-002902-29-GB
Active, not recruiting
Phase 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 enrollmentNovember 26, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Not provided
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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