Back to resultsExploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
MT-1303 Low dose
MT-1303 High dose
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic lupus erythematosus
Eligibility Criteria
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
Sites / Locations
- Inverstigational site
- Inverstigational site
- Inverstigational site
- Inverstigational site
- Investigational site
- Inverstigational site
- Inverstigational site
- Inverstigational site
- Investigational site
- Investigational site
- Inverstigational site
- Inverstigational site
- Inverstigational site
- Investigational site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Part 1
Part 2-A
Part 2-B
Arm Description
MT-1303 Low dose+Corticosteroid
MT-1303 High dose+Corticosteroid
MT-1303 Low dose+Corticosteroid+Immunosuppressant
Outcomes
Primary Outcome Measures
Number of Subjects with Adverse Events
Secondary Outcome Measures
Change from Baseline in anti-dsDNA and complement
Change from Baseline in Lymphocyte counts
Full Information
NCT ID
NCT02307643
First Posted
November 18, 2014
Last Updated
June 13, 2017
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02307643
Brief Title
Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients
Official Title
An Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic lupus erythematosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1
Arm Type
Experimental
Arm Description
MT-1303 Low dose+Corticosteroid
Arm Title
Part 2-A
Arm Type
Experimental
Arm Description
MT-1303 High dose+Corticosteroid
Arm Title
Part 2-B
Arm Type
Experimental
Arm Description
MT-1303 Low dose+Corticosteroid+Immunosuppressant
Intervention Type
Drug
Intervention Name(s)
MT-1303 Low dose
Intervention Type
Drug
Intervention Name(s)
MT-1303 High dose
Primary Outcome Measure Information:
Title
Number of Subjects with Adverse Events
Time Frame
up to 36 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in anti-dsDNA and complement
Time Frame
baseline and 24 weeks
Title
Change from Baseline in Lymphocyte counts
Time Frame
baseline and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsutomu Takeuchi, MD
Organizational Affiliation
Keio University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yoshiya Tanaka, MD
Organizational Affiliation
University of Occupational and Environmental Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Inverstigational site
City
Bunkyo-ku
Country
Japan
Facility Name
Inverstigational site
City
Chiba-shi
Country
Japan
Facility Name
Inverstigational site
City
Chuo-ku
Country
Japan
Facility Name
Inverstigational site
City
Fuchu-shi
Country
Japan
Facility Name
Investigational site
City
Fukuoka-shi
Country
Japan
Facility Name
Inverstigational site
City
Kawagoe-shi
Country
Japan
Facility Name
Inverstigational site
City
Maebashi-shi
Country
Japan
Facility Name
Inverstigational site
City
Meguro-ku
Country
Japan
Facility Name
Investigational site
City
Narashino-shi
Country
Japan
Facility Name
Investigational site
City
Sendai-shi
Country
Japan
Facility Name
Inverstigational site
City
Shimotsuga-gun
Country
Japan
Facility Name
Inverstigational site
City
Shinjuku-ku
Country
Japan
Facility Name
Inverstigational site
City
Tsukuba-shi
Country
Japan
Facility Name
Investigational site
City
Urayasu-shi
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
33115374
Citation
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.
Results Reference
derived
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Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients
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