Systemic Sclerosis
Conditions
Brief summary
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.
Interventions
DRUGInebilizumab
Participants will receive IV inebilizumab.
DRUGPlacebo
Participants will receive IV placebo matched to inebilizumab.
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Additional screening criteria check may apply for qualification: 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
Additional screening criteria check may apply for qualification: 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 | baseline, RCP 4, 12, 26, OLP 4,12, 26, the long-term extension period 26, 52, 78, 104 weeks |
Secondary
| Measure | 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 |
Countries
Japan
Outcome results
None listed