A Study of MT-0551 in Patients With Systemic Sclerosis

Sponsor
Tanabe Pharma Corporation
Study ID
NCT05198557
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Inebilizumab — DRUG
    Participants will receive IV inebilizumab.
  • Placebo — DRUG
    Participants will receive IV placebo matched to inebilizumab.

Study Details

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.

Key Dates

Start date
Jul 20, 2022
Status verified
Dec 2025
Primary completion
Jul 31, 2025
Completion
Aug 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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 IV inebilizumab on Day 1 and IV placebo on Day 15 of OLP and will be followed by IV inebilizumab every 26 weeks.
  • Placebo Comparator: Placebo group
    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.

Primary Outcome Measure

Change from baseline in the mRTSS up to the end of the long-term extension period [ Time Frame: baseline, RCP 4, 12, 26, OLP 4,12, 26, the long-term extension period 26, 52, 78, 104 weeks ]

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