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Active, Not Recruiting

NCT Number: NCT05198557

A Study of MT-0551 in Patients With Systemic Sclerosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Fukui Hospital, Yoshida-gun, Fukui, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Inebilizumab

Drug

Participants will receive IV inebilizumab.

Other names: MT-0551

Placebo

Drug

Participants will receive IV placebo matched to inebilizumab.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

    Time frame: Baseline to at least 52 weeks or early termination

  2. Pulmonary function tests: Percentage change from baseline in the %FVC and %DLco

    Time frame: Baseline to at least 52 weeks or early termination

  3. Change from baseline in the mRTSS

    Time frame: Baseline to at least 52 weeks or early termination

  4. Composite response index in diffuse cutaneous systemic sclerosis

    Time frame: Week 26 to at least 52 weeks or early termination

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

Phase 3 Study of MT-0551 in Patients With Systemic Sclerosis (Placebo-Controlled Double-Blind Study)

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 20, 2022
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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