Phase 3 Study of MT-0551 in Patients with Systemic Sclerosis
- Conditions
- Systemic Sclerosis
- Registration Number
- JPRN-jRCT2031210521
- Lead Sponsor
- Kondou Kazuoki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
(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.
(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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method