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.
- Conditions
- Crohn's disease - inflammatory bowel disease10017969
- Registration Number
- NL-OMON41584
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- 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 < or<=450.;- Presence of mucosal ulcers in at least one segment of the ileum or colon and a CDEIS
score * 7 (for patients with isolated ileitis *4), as assessed by ileocolonoscopy and
confirmed by central independent reviewer(s) before randomization.;- Non-responsiveness or intolerance to previous standard treatment with at least 2 TNF antagonists (infliximab, adalimumab, or certolizumab pegol) at a dose approved for Crohn*s disease.
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>to evaulate the efficacy of BI655066 in inducing clinical remission defined as<br /><br>CDAI<150 after 12 weeks of treatment </p><br>
- Secondary Outcome Measures
Name Time Method <p>- To evaluate efficacy of BI 655066 in inducing endoscopic response, clinical<br /><br>response, mucosal healing and deep remission.<br /><br>- To evaluate safety of BI 655066.<br /><br>- To explore the pharmacokinetics and pharmacodynamics of BI 655066<br /><br>therapy in Crohn*s disease</p><br>