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NCT07687459
Study Evaluation Rentosertib (INS018_055) Administered Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Conditions: Idiopathic Pulmonary Fibrosis
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 320
Sponsor: InSilico Medicine Hong Kong Limited
Location: Anhui Chest Hospital Hefei Anhui
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. An informed consent form (ICF) signed and dated at screening (Visit 1), prior to initiation of any study related procedures, and in accordance with ICH-GCP and local legislation.
2. Patients aged ≥40 years at time of signing the ICF.
3. Diagnosis of IPF based on the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guideline, confirmed by an HRCT chest scan within 3 months prior to screening visit.
4. UIP or probable UIP with fibrosis extent \>10% at HRCT.
5. Meet all the following criteria during the screening period:
1. FVC ≥45% predicted of normal
2. FEV1/FVC ≥0.7
3. DLCO (corrected for hemoglobin) ≥25% and \
Source: ClinicalTrials.gov (NCT07687459). StuddyBuddy aggregates publicly available trial information.