Evaluating the safety and efficacy of a new biologic targeted therapy versus placebo in adults with systemic sclerosis

Overview

Systemic sclerosis (SSc) is a rare and rapidly progressive autoimmune disease that affects multiple organs and has one of the highest mortality rates among rheumatic diseases. Current therapies provide only limited benefit. This Phase 3 study evaluates a novel targeted therapy that inhibits type I interferon signaling (already approved for the treatment of moderate to severe systemic lupus erythematosus), with the expectation of controlling disease activity, slowing progression of skin and lung involvement, improving quality of life, and opening new treatment options for patients with SSc.

Inclusion Criteria

Men and women aged 18–70 years with a confirmed diagnosis of systemic sclerosis, with disease duration ≤6 years from first non-Raynaud’s symptom
Evidence of significant skin and/or lung involvement with active disease
May be on stable background therapy (such as methotrexate, mycophenolate, azathioprine, low-dose corticosteroids, etc.)

Exclusion Criteria

Severe pulmonary hypertension, heart failure, or uncontrolled cardiovascular disease
SSc-related kidney disease with eGFR <45 mL/min/1.73 m²
Severe lung disease (FVC ≤50% or DLCO ≤45% or significant airway obstruction)
Active infection or history of serious opportunistic infections
Active hepatitis B, hepatitis C, HIV, or tuberculosis

PI

Assoc. Prof, MD Nguyễn Văn Đĩnh – Clinical Allergy–Immunology Center, Vinmec Times City Internation Hospital

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