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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02389790

Enrollment

Registered

2015-03-17

Start date

2015-08-31

Completion date

2017-08-31

Last updated

2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's Disease

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）

Interventions

DRUGMT-1303

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Number of Subjects with Adverse Events	36 weeks

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026