A Study of MT-0551 in Patients With Systemic Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Phase 3 Study of MT-0551 in Patients With Systemic Sclerosis (Placebo-Controlled Double-Blind Study)

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Drug: Inebilizumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Additional screening criteria check may apply for qualification: ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied. Skin thickening score based on the mRTSS between 10 and 22 inclusive. Exclusion Criteria: Additional screening criteria check may apply for qualification: Pulmonary hypertension associated with SSc. Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia. Finding of inadequate respiratory reserve capacity. Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab. Presence of a clinically significant active infection requiring antimicrobial therapy. A past history of cancer. Past history of a recurrent, clinically significant infection. Past history of severe allergy or anaphylactic reaction to a biologic drug product. Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-0551 group<br>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. | Drug: Inebilizumab<br>* Participants will receive IV inebilizumab.<br>* Other names: MT-0551;Drug: Placebo<br>* Participants will receive IV placebo matched to inebilizumab.<br>|
| Placebo Comparator: Placebo group<br>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. | Drug: Inebilizumab<br>* Participants will receive IV inebilizumab.<br>* Other names: MT-0551;Drug: Placebo<br>* Participants will receive IV placebo matched to inebilizumab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the mRTSS at Week 26 |  | Baseline and Week 26 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |