SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
NCT06125327 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2024-11-19
Summary
Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.
Conditions
Interventions
- DRUG
-
SC1011
Patients receive the dose of SC1011 tablets orally twice daily (b.i.d) for 52 weeks.
- DRUG
-
Placebo comparator
Patients receive the dose of placebo orally twice daily (b.i.d) for 52 weeks.
Sponsors & Collaborators
-
Guangzhou JOYO Pharma Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-06
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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