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CompletedNCT02389790Updated Sep 5, 2017

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

A Phase 2 interventional study of MT-1303 in Crohn's Disease, sponsored by Mitsubishi Tanabe Pharma Corporation. Completed at 11 sites in 11 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-09-05.

Sponsored by Mitsubishi Tanabe Pharma Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Crohn's Disease

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Keywords

  • Crohn's Disease
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 46 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Mitsubishi Tanabe Pharma Corporation is the lead sponsor of 40 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Permanent discontinuation of study medication prior to the end of treatment Visit in MT-1303-E13
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    MT-1303

    Drug: MT-1303

Interventions

  • DrugMT-1303
06

What researchers measure

Primary outcomes

  1. Number of Subjects with Adverse Events

    Time frame: 36 weeks

07

Study locations

11 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02389790
Lead sponsor
Mitsubishi Tanabe Pharma Corporation
Responsible party
Sponsor
First posted
Mar 17, 2015
Start date
Aug 2015
Primary completion
Aug 2017
Completion
Aug 2017
Last update
Sep 5, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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