Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307643
• Other study ID #: MT-1303-J03
• Status: Completed
• Phase: Phase 1
• First received: November 18, 2014
• Last updated: June 13, 2017
• Start date: February 2015
• Est. completion date: May 2017

Study information

• Verified date: June 2017
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• MT-1303 Low dose

• MT-1303 High dose

Locations

Country	Name	City	State
Japan	Inverstigational site	Bunkyo-ku
Japan	Inverstigational site	Chiba-shi
Japan	Inverstigational site	Chuo-ku
Japan	Inverstigational site	Fuchu-shi
Japan	Investigational site	Fukuoka-shi
Japan	Inverstigational site	Kawagoe-shi
Japan	Inverstigational site	Maebashi-shi
Japan	Inverstigational site	Meguro-ku
Japan	Investigational site	Narashino-shi
Japan	Investigational site	Sendai-shi
Japan	Inverstigational site	Shimotsuga-gun
Japan	Inverstigational site	Shinjuku-ku
Japan	Inverstigational site	Tsukuba-shi
Japan	Investigational site	Urayasu-shi

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects with Adverse Events		up to 36 weeks
Secondary	Change from Baseline in anti-dsDNA and complement		baseline and 24 weeks
Secondary	Change from Baseline in Lymphocyte counts		baseline and 24 weeks