A Study of MT-0551 in Patients With Systemic Sclerosis

Phase 3Active Not RecruitingNCT05198557

Tanabe Pharma Corporation80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Systemic Sclerosis

Interventions

InebilizumabDRUG

Participants will receive IV inebilizumab.

PlaceboDRUG

Participants will receive IV placebo matched to inebilizumab.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: Additional screening criteria check may apply for qualification: 1. ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied. 2. Skin thickening score based on the mRTSS between 10 and 22 inclusive. Exclusion Criteria: Additional screening criteria check may apply for qualification: 1. Pulmonary hypertension associated with SSc. 2. Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia. 3. Finding of inadequate respiratory reserve capacity. 4. Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab. 5. Presence of a clinically significant active infection requiring antimicrobial therapy. 6. A past history of cancer. 7. Past history of a recurrent, clinically significant infection. 8. Past history of severe allergy or anaphylactic reaction to a biologic drug product. 9. Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).

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

Outcomes

Primary Outcomes

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

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

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

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

Change from baseline in the mRTSS

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

Composite response index in diffuse cutaneous systemic sclerosis

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

Data from ClinicalTrials.gov

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