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

October 12, 2016 updated by: Mitsubishi Tanabe Pharma Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • City Name, Czech Republic
        • Investigational Site
  • France
      • City Name, France
        • Investigational Site
  • Germany
      • City Name, Germany
        • Investigational Site
  • Hungary
      • City Name, Hungary
        • Investigational Site
  • Israel
      • City Name, Israel
        • Investigational Site
  • Italy
      • City Name, Italy
        • Investigational Site
  • Japan
      • City Name, Japan
        • Investigational Site
  • Netherlands
      • City Name, Netherlands
        • Investigational Site
  • Poland
      • City Name, Poland
        • Investigational Site
  • Slovakia
      • City Name, Slovakia
        • Investigational Site
  • Ukraine
      • City Name, Ukraine
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: MT-1303
Drug: MT-1303

What is the study measuring?

Primary Outcome Measures

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)
Time Frame: 14 weeks
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-1303-E13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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