NCT06125327

SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)

A Randomized, Double-blind, Placebo-controlled Phase II/III Trial Evaluating the Efficacy and Safety of Sufenidone (SC1011) Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF).

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Guangzhou JOYO Pharma Co., Ltd · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.

Detailed description

Randomized, double-blind study comparing Sufenidone (SC1011) and placebo in IPF patients, with interim analysis at 26 weeks to select the optimal dose for a 52-week treatment period followed by 4-week safety monitoring

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-06
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-11-09
• Last updated: 2024-11-19

Locations

1 site across 1 country: China