A Study of MT-0551 in Patients With Systemic Sclerosis
Systemic Sclerosis
About this trial
This is an interventional treatment trial for Systemic Sclerosis
Eligibility Criteria
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).
Sites / Locations
- University of Fukui HospitalRecruiting
- Kanazawa University HospitalRecruiting
- St. Marianna University HospitalRecruiting
- The University of Tokyo HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
MT-0551 group
Placebo 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.
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.