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NCT02389790 Clinical Trial

Extension Study of MT-1303 in Subjects With Crohn's Disease

Crohn's Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02389790
Other study ID # MT-1303-E14
Secondary ID
Status Completed
Phase Phase 2
First received March 10, 2015
Last updated September 1, 2017
Start date August 2015
Est. completion date August 2017

Study information
Verified date September 2017
Source Mitsubishi Tanabe Pharma Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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）

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- The subject completed 14 week Treatment Period in the double blind MT-1303-E13 study as per Protocol.

Exclusion Criteria:

- Permanent discontinuation of study medication prior to the end of treatment Visit in MT-1303-E13

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MT-1303

Locations
Country Name City State
Czechia Investigational site City Name
France Investigational site City Name
Germany Investigational site City Nmae
Hungary Investigational site City Nmae
Israel Investigational site City Name
Italy Investigational site City Name
Japan Investigational site City Nmae
Netherlands Investigational site City Name
Poland Investigational site City Name
Slovakia Investigational site City Name
Ukraine Investigational site City Name

Sponsors (1)
Lead Sponsor Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Netherlands,  Poland,  Slovakia,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects with Adverse Events 36 weeks
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