Extension Study of MT-1303 in Subjects With Crohn's Disease
A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study
1 other identifier
interventional
46
11 countries
11
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）
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2015
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedSeptember 5, 2017
September 1, 2017
2 years
March 10, 2015
September 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects with Adverse Events
36 weeks
Study Arms (1)
MT-1303
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- The subject completed 14 week Treatment Period in the double blind MT-1303-E13 study as per Protocol.
You may not qualify if:
- Permanent discontinuation of study medication prior to the end of treatment Visit in MT-1303-E13
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Investigational site
City Name, Czechia
Investigational site
City Name, France
Investigational site
City Nmae, Germany
Investigational site
City Nmae, Hungary
Investigational site
City Name, Israel
Investigational site
City Name, Italy
Investigational site
City Nmae, Japan
Investigational site
City Name, Netherlands
Investigational site
City Name, Poland
Investigational site
City Name, Slovakia
Investigational site
City Name, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2015
First Posted
March 17, 2015
Study Start
August 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
September 5, 2017
Record last verified: 2017-09