Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease
Phase 2
Completed
- Conditions
- Crohn's Disease
- Interventions
- Drug: MT-1303Drug: Placebo
- Registration Number
- NCT02378688
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
The primary objectives of the study are:
* To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）
* To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
- Diagnosis of CD (involving small intestine and/or colon), confirmed by both endoscopy and histopathology at least 3 months prior to Visit 1
- Previous use of any type of corticosteroids or immunosuppressants for the treatment of CD
- Moderate to severe active CD defined by a CDAI score of ≥220 to ≤450 points at Visit 1
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Exclusion Criteria
- Diagnosis of ulcerative colitis, indeterminate colitis, pseudomembranous colitis or coeliac disease
- Enterocutaneous, abdominal or pelvic active fistulae, abscesses or fistulae likely to require surgery during the study
- GI surgery (including appendectomy) within 12 weeks prior to Visit 2 (Baseline) or has surgery planned or deemed likely to require surgery for CD during the study
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MT-1303 MT-1303 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Proportion of subjects who achieve a 100-point decrease from Baseline in CDAI(Crohn's Disease Activity Index) score (i.e., CDAI 100) at Visit 6 (Week 12) 14 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Investigational site
🇺🇦City Name, Ukraine
Investigational Site
🇩🇪City Name, Germany