Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients

Tanabe Pharma Corporation17 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

MT-1303 Low doseDRUG

MT-1303 High doseDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (14)

Inverstigational site

Bunkyō City, Japan

Inverstigational site

Chiba, Japan

Inverstigational site

Chūōku, Japan

Outcomes

Primary Outcomes

Number of Subjects with Adverse Events

Time frame: up to 36 weeks

Secondary Outcomes

Change from Baseline in anti-dsDNA and complement

Time frame: baseline and 24 weeks

Change from Baseline in Lymphocyte counts

Time frame: baseline and 24 weeks

Data from ClinicalTrials.gov

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