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ACTIVE NOT RECRUITING
NCT05198557
PHASE3

A Study of MT-0551 in Patients With Systemic Sclerosis

Sponsor: Tanabe Pharma Corporation

View on ClinicalTrials.gov

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

Interventions

DRUG

Inebilizumab

Participants will receive IV inebilizumab.

DRUG

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