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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02378688

Enrollment

Registered

2015-03-04

Start date

2015-03-31

Completion date

2016-10-31

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's Disease

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.

Interventions

DRUGMT-1303

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Countries

Czechia, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, Slovakia, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026