A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

Sponsors

Lead sponsor: Mitsubishi Tanabe Pharma Corporation

Source Mitsubishi Tanabe Pharma Corporation
Brief Summary

The primary objectives of the study are:

- To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease(CD)

- To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.

Overall Status Completed
Start Date March 2015
Completion Date October 2016
Primary Completion Date October 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of subjects who achieve a 100-point decrease from Baseline in CDAI(Crohn's Disease Activity Index) score (i.e., CDAI 100) at Visit 6 (Week 12) 14 weeks
Enrollment 78
Condition
Intervention

Intervention type: Drug

Intervention name: MT-1303

Arm group label: MT-1303

Intervention type: Drug

Intervention name: Placebo

Arm group label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- Diagnosis of CD (involving small intestine and/or colon), confirmed by both endoscopy and histopathology at least 3 months prior to Visit 1

- Previous use of any type of corticosteroids or immunosuppressants for the treatment of CD

- Moderate to severe active CD defined by a CDAI score of ≥220 to ≤450 points at Visit 1

Exclusion Criteria:

- Diagnosis of ulcerative colitis, indeterminate colitis, pseudomembranous colitis or coeliac disease

- Enterocutaneous, abdominal or pelvic active fistulae, abscesses or fistulae likely to require surgery during the study

- GI surgery (including appendectomy) within 12 weeks prior to Visit 2 (Baseline) or has surgery planned or deemed likely to require surgery for CD during the study

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Location
facility
Investigational site | City Name, Czech Republic
Investigational site | City Name, France
Investigational Site | City Name, Germany
Investigational site | City Name, Hungary
Investigational site | City Name, Israel
Investigational site | City Name, Italy
Investigational site | City Name, Japan
Investigational site | City Name, Netherlands
Investigational site | City Name, Poland
Investigational site | City Name, Slovakia
Investigational site | City Name, Ukraine
Location Countries

Czech Republic

France

Germany

Hungary

Israel

Italy

Japan

Netherlands

Poland

Slovakia

Ukraine

Verification Date

October 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: MT-1303

Arm group type: Experimental

Arm group label: Placebo

Arm group type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov