drugset / Trial / NCT05300932
A Study Evaluating the Efficacy and Safety of Baricitinib in Systemic Sclerosis
Phase 4
Active not recruiting
60 enrolled
Tongji Hospital
Eli Lilly and Company · collabJohns Hopkins University · collabRenmin Hospital of Wuhan University · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-03-08
- Primary completion
- 2026-08-01
- Completion
- 2026-11-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baricitinib | Small molecule | 4 mg | Oral |
| Comparator | Cyclophosphamide | Other / unclassified | 400 mg | Intravenous |
| Comparator | Prednisone | Other / unclassified | 10 mg | Oral |
| Comparator | Prednisone | Other / unclassified | 15 mg | Oral |