A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 study

Phase 1

• Conditions: MedDRA version: 18.1Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856; Subjects with moderate to severe crohn's disease; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2014-002557-19-CZ
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation (MTPC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-30
• Last Update Posted: 6 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. The subject completed the 14 week Treatment Period in the doubleblind
MT-1303-E13 study as per Protocol.
2. The subject is able to provide written informed consent and to comply
with the requirements of the MT-1303-E14 Protocol during the study.
3. For subjects of reproductive potential, two methods of contraception
must be used throughout the study and for 12 weeks after cessation of
study medication. At least one of the methods of contraception must be
a barrier method.

For detailed information, please refer to the Protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 79
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1. Permanent discontinuation of study medication prior to the EOT Visit in MT-1303-E13
2. Newly diagnosed diabetes mellitus during the double blind MT-1303-E13 study.

For detailed information, please refer to the Protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified