Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients

June 13, 2017 updated by: Mitsubishi Tanabe Pharma Corporation

An Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study)

The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy of MT-1303 in subjects with systemic lupus erythematosus

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Bunkyo-ku, Japan
        • Inverstigational site
      • Chiba-shi, Japan
        • Inverstigational site
      • Chuo-ku, Japan
        • Inverstigational site
      • Fuchu-shi, Japan
        • Inverstigational site
      • Fukuoka-shi, Japan
        • Investigational Site
      • Kawagoe-shi, Japan
        • Inverstigational site
      • Maebashi-shi, Japan
        • Inverstigational site
      • Meguro-ku, Japan
        • Inverstigational site
      • Narashino-shi, Japan
        • Investigational Site
      • Sendai-shi, Japan
        • Investigational Site
      • Shimotsuga-gun, Japan
        • Inverstigational site
      • Shinjuku-ku, Japan
        • Inverstigational site
      • Tsukuba-shi, Japan
        • Inverstigational site
      • Urayasu-shi, Japan
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of SLE based on the American College of Rheumatology (ACR) criteria
  • Presence of at least one of the following items: positive anti ds-DNA antibodies, low complement levels, and so on.
  • Stable doses of corticosteroids

Exclusion Criteria:

  • Severe active lupus nephritis, neuropsychiatric SLE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1
MT-1303 Low dose+Corticosteroid
Drug: MT-1303 Low dose
Experimental: Part 2-A
MT-1303 High dose+Corticosteroid
Drug: MT-1303 High dose
Experimental: Part 2-B
MT-1303 Low dose+Corticosteroid+Immunosuppressant
Drug: MT-1303 Low dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects with Adverse Events
Time Frame: up to 36 weeks
up to 36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in anti-dsDNA and complement
Time Frame: baseline and 24 weeks
baseline and 24 weeks
Change from Baseline in Lymphocyte counts
Time Frame: baseline and 24 weeks
baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Investigators

  • Study Chair: Tsutomu Takeuchi, MD, Keio University Hospital
  • Study Director: Yoshiya Tanaka, MD, University of Occupational and Environmental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-1303-J03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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