Extension Study of MT-1303 in Subjects With Crohn's Disease

NCT ID: NCT02389790

Last Updated: 2017-09-05

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objectives of the study are:

-To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease(CD)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MT-1303

Group Type EXPERIMENTAL

MT-1303

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MT-1303

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The subject completed 14 week Treatment Period in the double blind MT-1303-E13 study as per Protocol.

Exclusion Criteria

* Permanent discontinuation of study medication prior to the end of treatment Visit in MT-1303-E13
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Investigational site

City Name, , Czechia

Site Status

Investigational site

City Name, , France

Site Status

Investigational site

City Nmae, , Germany

Site Status

Investigational site

City Nmae, , Hungary

Site Status

Investigational site

City Name, , Israel

Site Status

Investigational site

City Name, , Italy

Site Status

Investigational site

City Nmae, , Japan

Site Status

Investigational site

City Name, , Netherlands

Site Status

Investigational site

City Name, , Poland

Site Status

Investigational site

City Name, , Slovakia

Site Status

Investigational site

City Name, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Czechia France Germany Hungary Israel Italy Japan Netherlands Poland Slovakia Ukraine

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MT-1303-E14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Control Crohn Safe Trial
NCT03917303 RECRUITING PHASE4
Open-Label Extension Study of GSK1605786A
NCT01318993 TERMINATED PHASE3
B0151005 Open-Label Extension Study
NCT01345318 COMPLETED PHASE2
Fecal Transplant for Crohn's Disease
NCT03078803 COMPLETED PHASE2