Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.
Phase 1
Active, not recruiting
- Conditions
- Crohn's diseaseTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-002902-29-BE
- Lead Sponsor
- SCS Boehringer Ingelheim Comm.V
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 120
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate efficacy of BI 655066 in inducing clinical remission, defined as CDAI [Crohn's Disease Activity Index] <150 after 12 weeks of treatment.;Secondary Objective: To evaluate efficacy, safety and pharmacokinetics of BI 655066 therapy in Crohn's disease.;Primary end point(s): 1: Proportion of patients achieving clinical remission at week 12, defined as a CDAI score of < 150.<br>;Timepoint(s) of evaluation of this end point: 1: week 12<br>
- Secondary Outcome Measures
Name Time Method