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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: MT-1303

Study type: Interventional

Funder types: Industry

Identifiers

NCT02389790

MT-1303-E14

Details and patient eligibility

About

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）

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

MT-1303

Experimental group

Treatment:

Drug: MT-1303