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Completed

NCT Number: NCT02378688

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

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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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational site, City Name, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-1303

Drug

Placebo

Drug

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)

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2015
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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