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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Placebo; Drug: MT-1303

Study type: Interventional

Funder types: Industry

Identifiers

NCT02378688

MT-1303-E13

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups, including a placebo group

MT-1303

Experimental group

Treatment:

Drug: MT-1303

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo