Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02307643

Enrollment

Registered

2014-12-04

Start date

2015-02-28

Completion date

2017-05-31

Last updated

2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosus

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

Interventions

DRUGMT-1303 Low dose

DRUGMT-1303 High dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame
Number of Subjects with Adverse Events	up to 36 weeks

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026