Phase 3 Study of MT-0551 in Patients with Systemic Sclerosis

Active, not recruiting

• Conditions: Systemic Sclerosis

• Registration Number: jRCT2031210521
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-26
• Study Start: 2022-07-20
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

(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

(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).

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Change from baseline in the mRTSS up to the end of the long-term extension period

Secondary Outcome Measures

Name	Time	Method
Pulmonary function tests		Change and percentage change from baseline in the percent predicted forced vital capacity (%FVC) and percent predicted diffusing capacity of the lung carbon monoxide (%DLco)
mRTSS		Change from baseline in the mRTSS
Composite response index in diffuse cutaneous systemic sclerosis		Composite response index in diffuse cutaneous systemic sclerosis