Phase 3RecruitingAge-related condition
Study Evaluation Rentosertib (INS018_055) Administered Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Prospective Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Rentosertib (INS018_055) Administered Orally Over 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- Sponsor
- InSilico Medicine Hong Kong Limited (Industry)
- Enrolment
- 320 planned
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- INS018_055 tablets; Placebo
- Ages
- adults, older adults
- Registry
- NCT07687459
Full record on ClinicalTrials.gov
From the registry
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Rentosertib (INS018\_055) administered orally in Patients with Idiopathic Pulmonary Fibrosis. The purpose of this study is to evaluate if Rentosertib (INS018\_055) works to treat patients with Idiopathic Pulmonary Fibrosis in adults. It will also learn about the safety of Rentosertib (INS018\_055). In this study, Rentosertib (INS018\_055) will be compared to a placebo (a look-alike substance that contains no drug) to investigate if Rentosertib (INS018\_055) works to treat Idiopathic Pulmonary Fibrosis.
Primary outcomes
- the annual rate of forced vital capacity (FVC; mL) decline over 52 weeks.
History
Primary completion expected
Last registry update
Started
Registered