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The study will verify the superiority of MT-0551 to placebo at 26 weeks after treatment initiation in systemic sclerosis (SSc) patients using the modified Rodnan Total Skin thickness Score (mRTSS) as a measure of skin thickening. The safety and pharmacokinetics will also be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-0551 group | Experimental | Participants will receive intravenous (IV) inebilizumab on Day 1 and Day 15 of randomized controlled period (RCP). The participants who entered open label period (OLP) will receive IV inebilizumab on Day 1 and IV placebo on Day 15 of OLP and will be followed by IV inebilizumab every 26 weeks. |
|
| Placebo group | Placebo Comparator | Participants will receive IV placebo on Day 1 and Day 15 of the RCP. The participants who entered OLP will receive IV inebilizumab on both Day 1 and Day 15 in OLP and will be followed by IV inebilizumab every 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inebilizumab | Drug | Participants will receive IV inebilizumab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the mRTSS up to the end of the long-term extension period | baseline, RCP 4, 12, 26, OLP 4,12, 26, the long-term extension period 26, 52, 78, 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function tests: Change from baseline in the percent predicted forced vital capacity (%FVC) and percent predicted diffusing capacity of the lung carbon monoxide (%DLco) | Baseline to at least 52 weeks or early termination | |
| Pulmonary function tests: Percentage change from baseline in the %FVC and %DLco |
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Inclusion Criteria:
Additional screening criteria check may apply for qualification:
Exclusion Criteria:
Additional screening criteria check may apply for qualification:
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Fukui Hospital | Yoshida-gun | Fukui | 910-1193 | Japan | ||
| Kanazawa University Hospital |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 1, 2026 |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000609745 | inebilizumab |
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| Placebo | Drug | Participants will receive IV placebo matched to inebilizumab. |
|
| Baseline to at least 52 weeks or early termination |
| Change from baseline in the mRTSS | Baseline to at least 52 weeks or early termination |
| Composite response index in diffuse cutaneous systemic sclerosis | Week 26 to at least 52 weeks or early termination |
| Kanazawa |
| Ishikawa-ken |
| 920-8641 |
| Japan |
| St. Marianna University Hospital | Kawasaki-shi | Kanagawa | 216-8511 | Japan |
| The University of Tokyo Hospital | Bunkyo-ku | Tokyo | 113-8655 | Japan |