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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MT-1303
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MT-1303

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects with Adverse Events

Secondary Outcome Measures

Full Information

First Posted
March 10, 2015
Last Updated
September 1, 2017
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02389790
Brief Title
Extension Study of MT-1303 in Subjects With Crohn's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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）

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-1303
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MT-1303
Primary Outcome Measure Information:
Title
Number of Subjects with Adverse Events
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Investigational site
City
City Name
Country
Czechia
Facility Name
Investigational site
City
City Name
Country
France
Facility Name
Investigational site
City
City Nmae
Country
Germany
Facility Name
Investigational site
City
City Nmae
Country
Hungary
Facility Name
Investigational site
City
City Name
Country
Israel
Facility Name
Investigational site
City
City Name
Country
Italy
Facility Name
Investigational site
City
City Nmae
Country
Japan
Facility Name
Investigational site
City
City Name
Country
Netherlands
Facility Name
Investigational site
City
City Name
Country
Poland
Facility Name
Investigational site
City
City Name
Country
Slovakia
Facility Name
Investigational site
City
City Name
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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