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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)
Guangzhou JOYO Pharma Co., Ltd·Phase 2/3·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Idiopathic Pulmonary Fibrosis
Drug/Device/Intervention
SC1011
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Guangzhou JOYO Pharma Co., Ltd
Location
Beijing, China
Timeline & enrollment
Phase
Phase 2/3
Start date
Jun 06, 2023
End date
Dec 31, 2025
Enrollment
210 participants
Primary outcome

Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of Sufenidone (SC1011)
 in patients with IPF, and to provide a new safe and effective treatment option for patients
 with IPF. Participants will complete the study including screening period, treating period,
 and follow-up period. Investigators will compare the annual rate of decline in FVC to see if
 it is an optional new drug. The participants have lung function tests at study visits. The
 results of the lung function tests are compared between the SC1011 groups and the placebo
 group. The doctors also regularly check the general health of the participants.

ICD-10 classifications
Other interstitial pulmonary diseases with fibrosisCystic fibrosis with pulmonary manifestationsCystic fibrosisGraphite fibrosis (of lung)Pulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06125327
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06125327 through Pure Global AI's free database. This Phase 2/3 trial is sponsored by Guangzhou JOYO Pharma Co., Ltd and is currently Recruiting. The study focuses on Idiopathic Pulmonary Fibrosis. Target enrollment is 210 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.