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: Subjects with moderate to severe crohn's disease
MedDRA version: 18.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2014-002557-19-SK

Lead Sponsor: Mitsubishi Tanabe Pharma Corporation (MTPC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. The subject showed a decrease in CDAI of at least 70 points from the baseline CDAI score (i.e., Visit 2) at Week 12 in the double-blind MT-1303-E13 study.
2. The subject completed the 14 week Treatment Period in the double-blind MT-1303-E13 study as per Protocol.
3. The subject is able to provide written informed consent and to comply with the requirements of the MT-1303-E14 Protocol during the study.
4. 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active CD;Secondary Objective: • To evaluate the long-term effects of MT-1303 on clinical outcomes in subjects with moderate to severe active CD <br>• To explore the pharmacodynamic (PD) effects of MT-1303 in subjects with moderate to severe active CD.<br>;Primary end point(s): Safety, assessed by:<br>- Adverse events (AEs)<br>- Vital signs (pulse rate, blood pressure [BP] and body temperature)<br>- 12-lead ECG<br>- Holter ECG monitoring<br>- Routine safety laboratory assessments<br>- Physical examination (including skin assessment)<br>- OCT<br>;Timepoint(s) of evaluation of this end point: Various time points throughout the study - please refer to the detailed ‘Time and Events Schedule’ table in the protocol for full details.

Secondary Outcome Measures