Extension Study of MT-1303 in Subjects With Crohn's Disease
Phase 2
Completed
- Conditions
- Crohn's Disease
- Interventions
- Drug: MT-1303
- Registration Number
- NCT02389790
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
The primary objectives of the study are:
-To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
- The subject completed 14 week Treatment Period in the double blind MT-1303-E13 study as per Protocol.
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Exclusion Criteria
- Permanent discontinuation of study medication prior to the end of treatment Visit in MT-1303-E13
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MT-1303 MT-1303 -
- Primary Outcome Measures
Name Time Method Number of Subjects with Adverse Events 36 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Investigational site
🇺🇦City Name, Ukraine