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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | MT-1303 Low dose+Corticosteroid |
|
| Part 2-A | Experimental | MT-1303 High dose+Corticosteroid |
|
| Part 2-B | Experimental | MT-1303 Low dose+Corticosteroid+Immunosuppressant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-1303 Low dose | Drug |
| ||
| MT-1303 High dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Adverse Events | up to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in anti-dsDNA and complement | baseline and 24 weeks | |
| Change from Baseline in Lymphocyte counts | baseline and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsutomu Takeuchi, MD | Keio University Hospital | Study Chair |
| Yoshiya Tanaka, MD | University of Occupational and Environmental Health | Study Director |
| Kazuoki Kondo, MD | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inverstigational site | Bunkyō City | Japan | ||||
| Inverstigational site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33115374 | Derived | 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. |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000624397 | amiselimod |
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|
| 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 |