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

Crohn's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378688
• Other study ID #: MT-1303-E13
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2015
• Last updated: October 12, 2016
• Start date: March 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: The Italian Medicines AgencyJapan: Ministry of Health, Labor and WelfareNetherlands: Medicines Evaluation Board (MEB)Slovakia: State Institute for Drug ControlIsrael: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• MT-1303

• Placebo

Locations

Country	Name	City	State
Czech Republic	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	Investigational site	City Name

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Czech Republic,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Netherlands,  Poland,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No