Systemic Sclerosis
Conditions
Interventions
(1)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 I
Sponsors
Kondou Kazuoki
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the mRTSS up to the end of the long-term extension period | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Pulmonary function tests: Change and percentage change from baseline in the percent predicted forced vital capacity (%FVC) and percent predicted diffusing capacity of the lung carbon monoxide (%DLco) (2)Change from baseline in the mRTSS (3)Composite response index in diffuse cutaneous systemic sclerosis | — |
Contacts
Public ContactClinical Trials Information Desk
Tanabe Pharma Corporation
Outcome results
None listed