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)
1 other identifier
interventional
17
1 country
14
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2015
Typical duration for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJune 14, 2017
June 1, 2017
2.2 years
November 18, 2014
June 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects with Adverse Events
up to 36 weeks
Secondary Outcomes (2)
Change from Baseline in anti-dsDNA and complement
baseline and 24 weeks
Change from Baseline in Lymphocyte counts
baseline and 24 weeks
Study Arms (3)
Part 1
EXPERIMENTALMT-1303 Low dose+Corticosteroid
Part 2-A
EXPERIMENTALMT-1303 High dose+Corticosteroid
Part 2-B
EXPERIMENTALMT-1303 Low dose+Corticosteroid+Immunosuppressant
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe active lupus nephritis, neuropsychiatric SLE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Inverstigational site
Bunkyō City, Japan
Inverstigational site
Chiba, Japan
Inverstigational site
Chūōku, Japan
Inverstigational site
Fuchu-shi, Japan
Investigational site
Fukuoka, Japan
Inverstigational site
Kawagoe-shi, Japan
Inverstigational site
Maebashi, Japan
Inverstigational site
Meguro-ku, Japan
Investigational site
Narashino-shi, Japan
Investigational site
Sendai, Japan
Inverstigational site
Shimotsuga-gun, Japan
Inverstigational site
Shinjuku-ku, Japan
Inverstigational site
Tsukuba, Japan
Investigational site
Urayasu-shi, Japan
Related Publications (1)
Tanaka Y, Kondo K, Ichibori A, Yanai Y, Susuta Y, Inoue S, Takeuchi T. Amiselimod, a sphingosine 1-phosphate receptor-1 modulator, for systemic lupus erythematosus: A multicenter, open-label exploratory study. Lupus. 2020 Dec;29(14):1902-1913. doi: 10.1177/0961203320966385. Epub 2020 Oct 28.
PMID: 33115374DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tsutomu Takeuchi, MD
Keio University Hospital
- STUDY DIRECTOR
Yoshiya Tanaka, MD
University of Occupational and Environmental Health
- STUDY DIRECTOR
Kazuoki Kondo, MD
Tanabe Pharma Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2014
First Posted
December 4, 2014
Study Start
February 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
June 14, 2017
Record last verified: 2017-06