A Study of MT-0551 in Patients With Systemic Sclerosis
- Registration Number
- NCT05198557
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo 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. MT-0551 group Inebilizumab 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. Placebo group Inebilizumab 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. MT-0551 group Placebo 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.
- Primary Outcome Measures
Name Time Method Change from baseline in the mRTSS at Week 26 Baseline and Week 26
- Secondary Outcome Measures
Name Time Method Composite response index in diffuse cutaneous systemic sclerosis Week 26 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 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
Trial Locations
- Locations (4)
University of Fukui Hospital
🇯🇵Yoshida-gun, Fukui, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
St. Marianna University Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan
The University of Tokyo Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan