NCT05300932

A Study Evaluating the Efficacy and Safety of Baricitinib in Systemic Sclerosis

Efficacy and Safety of Baricitinib in Systemic Sclerosis: a Phase IV, Double-blinded, Controlled Study.

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Systemic Sclerosis (Ssc) is a rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, including the musculoskeletal, cardiac, pulmonary, and gastrointestinal systems. Patients may experience many symptoms such as pain, fatigue, dyspnea, impaired hand function, dry mouth, and difficulty sleeping. As a result of these symptoms, these patients may experience a decrease in activities of daily living, physical activity level and quality of life, while psychological problems such as anxiety and depression may increase.

Detailed description

This is a 48 weeks, prospective, double-blind, controlled study. The specific objectives of this study are to: 1. Determine whether Baricitinib is effective and safe in the treatment of patients with diffuse cutaneous (dc)SSc when compared to patients treated with CTX. In this study, stand of care of GC is permitted to use. 2. Determine whether Baricitinib is more effective than CTX, as measured by change in CRISS, which is a composite outcome measure provisionally endorsed by the ACR for scleroderma clinical trials. It incorporates change in the mRSS, FVC percent predicted, physician and patient global assessments, and HAQ-DI. Additionally, hemoglobin corrected diffusion capacity (DLCO), Medsger Severity Scale (MSS), and by other physician and patient derived outcome measures will be used. 3. Determine the biological activity of Baricitinib vs CTX as assessed by effect on histology of skin, gene expression of skin and blood, change in B-Cell profiles including assessment of B regulatory cells, and effect on serological and cutaneous biomarkers of disease activity.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	Baricitinib	Orally take Baricitinib 4mg everyday for 48 weeks
DRUG	Cyclophosphamide	Subject received cyclophosphamide 400mg intravenous drip every 2 weeks combined with oral Prednisone 10-15 mg/d （standard of care）through the 24 weeks double blind period. Subsequently, subject were administered oral Baricitinib 4mg everyday through the 24-48 weeks open label period.

Timeline

• Start date: 2022-03-08
• Primary completion: 2026-08-01
• Completion: 2026-11-12
• First posted: 2022-03-29
• Last updated: 2026-01-27

Locations

2 sites across 1 country: China