SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled study using a phase II/III adaptive seamless design. The study isdivided into three treatment groups: two active treatment groups and one placebo group. An interim analysis will be performed after the completion of 26 weeks of treatment in 75 patients. According to the safety and efficacy results analyzed, the appropriate active dose will be selected. Subjects will be divided into 3 treatment groups in a ratio of 1:1:1; After the interim analysis, if the DMC selected a treatment dose, all new recruits would be randomly assigned to the treatment and placebo groups in a 2:1 ratio. Subjects who were enrolled before the interim analysis will be adjusted to continue treatment at the selected dose up to 52 weeks. This study includes screening period, treatment period and follow-up period. During the screening period, the subjects' lung imaging examinations performed at different centers required a central imaging diagnosis. The first dose after randomization is D1, and the treatment period for each subject is 52 weeks. All subjects will have a 4-week safety follow-up period after the end of treatment. Subjects who do not complete 52 weeks of treatment will also have a 4-week safety follow-up after the final dosing date. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06125327
Study type	Interventional
Source	Guangzhou JOYO Pharma Co., Ltd
Contact	zuojun xu
Phone	+86 010-69156114
Email	Xuzj@hotmail.com
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	June 6, 2023
Completion date	December 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms