Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease
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
1 other identifier
interventional
78
11 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2015
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 14, 2016
October 1, 2016
1.6 years
February 27, 2015
October 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
MT-1303
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Investigational site
City Name, Czechia
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2015
First Posted
March 4, 2015
Study Start
March 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
October 14, 2016
Record last verified: 2016-10