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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MT-1303
Placebo
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational site
  • Investigational site
  • Investigational Site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MT-1303

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
February 27, 2015
Last Updated
October 12, 2016
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02378688
Brief Title
Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-1303
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MT-1303
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Investigational site
City
City Name
Country
Czech Republic
Facility Name
Investigational site
City
City Name
Country
France
Facility Name
Investigational Site
City
City Name
Country
Germany
Facility Name
Investigational site
City
City Name
Country
Hungary
Facility Name
Investigational site
City
City Name
Country
Israel
Facility Name
Investigational site
City
City Name
Country
Italy
Facility Name
Investigational site
City
City Name
Country
Japan
Facility Name
Investigational site
City
City Name
Country
Netherlands
Facility Name
Investigational site
City
City Name
Country
Poland
Facility Name
Investigational site
City
City Name
Country
Slovakia
Facility Name
Investigational site
City
City Name
Country
Ukraine

12. IPD Sharing Statement

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

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