Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: MT-1303 High dose; Drug: MT-1303 Low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02307643

MT-1303-J03

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 3 patient groups

Part 1

Experimental group

Description:

MT-1303 Low dose+Corticosteroid

Treatment:

Drug: MT-1303 Low dose

Part 2-A

Experimental group

Description:

MT-1303 High dose+Corticosteroid

Treatment:

Drug: MT-1303 High dose

Part 2-B

Experimental group

Description:

MT-1303 Low dose+Corticosteroid+Immunosuppressant

Treatment:

Drug: MT-1303 Low dose