A Study of MT-0551 in Patients With Systemic Sclerosis
Phase 3
Active, not recruiting
- Conditions
- Systemic Sclerosis
- Interventions
- Drug: Placebo
- 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
- ACTIVE_NOT_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 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 Outcome Measures
Name Time Method Pulmonary function tests: Percentage change from baseline in the %FVC and %DLco 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 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
University of Fukui Hospital🇯🇵Yoshida-gun, Fukui, Japan