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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MT-1303

Group Type EXPERIMENTAL

MT-1303

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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MT-1303

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No