Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
80 participants
INTERVENTIONAL
2022-07-20
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MT-0551 group
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.
Inebilizumab
Participants will receive IV inebilizumab.
Placebo
Participants will receive IV placebo matched to inebilizumab.
Placebo group
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.
Inebilizumab
Participants will receive IV inebilizumab.
Placebo
Participants will receive IV placebo matched to inebilizumab.
Interventions
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Inebilizumab
Participants will receive IV inebilizumab.
Placebo
Participants will receive IV placebo matched to inebilizumab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied.
2. Skin thickening score based on the mRTSS between 10 and 22 inclusive.
Exclusion Criteria
1. Pulmonary hypertension associated with SSc.
2. Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia.
3. Finding of inadequate respiratory reserve capacity.
4. Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab.
5. Presence of a clinically significant active infection requiring antimicrobial therapy.
6. A past history of cancer.
7. Past history of a recurrent, clinically significant infection.
8. Past history of severe allergy or anaphylactic reaction to a biologic drug product.
9. Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).
20 Years
80 Years
ALL
No
Sponsors
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Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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General Manager
Role: STUDY_DIRECTOR
Tanabe Pharma Corporation
Locations
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University of Fukui Hospital
Yoshida-gun, Fukui, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan
Countries
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Other Identifiers
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MT-0551-A-301
Identifier Type: -
Identifier Source: org_study_id
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