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A Study of MT-0551 in Patients With Systemic Sclerosis
Sponsor: Tanabe Pharma Corporation
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.
Official title: Phase 3 Study of MT-0551 in Patients With Systemic Sclerosis (Placebo-Controlled Double-Blind Study)
Key Details
Gender
All
Age Range
20 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2022-07-20
Completion Date
2026-08
Last Updated
2025-12-08
Healthy Volunteers
No
Conditions
Interventions
Inebilizumab
Participants will receive IV inebilizumab.
Placebo
Participants will receive IV placebo matched to inebilizumab.
Locations (4)
University of Fukui Hospital
Yoshida-gun, Fukui, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan