NCT05198557

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
3mo left

Started Jul 2022

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jul 2022Aug 2026

First Submitted

Initial submission to the registry

January 6, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 20, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

January 6, 2022

Last Update Submit

December 4, 2025

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

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

    Baseline to at least 52 weeks or early termination

  • Change from baseline in the mRTSS

    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

Study Arms (2)

MT-0551 group

EXPERIMENTAL

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.

Drug: InebilizumabDrug: Placebo

Placebo group

PLACEBO COMPARATOR

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.

Drug: InebilizumabDrug: Placebo

Interventions

InebilizumabDRUG

Participants will receive IV inebilizumab.

Also known as: MT-0551
MT-0551 groupPlacebo group
PlaceboDRUG

Participants will receive IV placebo matched to inebilizumab.

MT-0551 groupPlacebo group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Fukui Hospital

Yoshida-gun, Fukui, 910-1193, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

St. Marianna University Hospital

Kawasaki-shi, Kanagawa, 216-8511, Japan

Location

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

inebilizumab

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • General Manager

    Tanabe Pharma Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 20, 2022

Study Start

July 20, 2022

Primary Completion

July 31, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

JP(4)