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Completed

NCT Number: NCT02307643

Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients

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

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inverstigational site, Bunkyō City, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MT-1303 Low dose

Drug

MT-1303 High dose

Drug

Primary outcomes

  1. Number of Subjects with Adverse Events

    Time frame: up to 36 weeks

Secondary outcomes

  1. Change from Baseline in anti-dsDNA and complement

    Time frame: baseline and 24 weeks

  2. Change from Baseline in Lymphocyte counts

    Time frame: baseline and 24 weeks

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 4, 2014
Registry last updated
Jun 14, 2017

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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