Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: MT-1303 Low dose; Drug: MT-1303 High dose

• Registration Number: NCT02307643
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-04
• Study Start: 2015-02
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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Exclusion Criteria

• Severe active lupus nephritis, neuropsychiatric SLE

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1	MT-1303 Low dose	MT-1303 Low dose+Corticosteroid
Part 2-A	MT-1303 High dose	MT-1303 High dose+Corticosteroid
Part 2-B	MT-1303 Low dose	MT-1303 Low dose+Corticosteroid+Immunosuppressant

Primary Outcome Measures

Name	Time	Method
Number of Subjects with Adverse Events	up to 36 weeks

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in anti-dsDNA and complement	baseline and 24 weeks
Change from Baseline in Lymphocyte counts	baseline and 24 weeks

Trial Locations

Locations (2)

Inverstigational site; 🇯🇵 Tsukuba-shi, Japan

Investigational site; 🇯🇵 Urayasu-shi, Japan