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.
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.
Patients aged ≥40 years at time of signing the ICF.
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.
UIP or probable UIP with fibrosis extent >10% at HRCT.
Interstitial lung disease associated with known primary diseases (eg, autoimmune disease-related interstitial lung diseases, sarcoidosis and amyloidosis), exposures (eg, radiation, silica, asbestos, and coal dust), or drugs (eg, amiodarone).
Concurrent participation in another interventional drug, device, or biological investigational research study, or use of an investigational agent within 5 half-lives of the agent (or within 8 weeks when half-life is unknown) prior to screening is not allowed.
Pulmonary hypertension that is clinically relevant or severe as deemed by the investigator, or other clinically significant pulmonary abnormalities.
Unstable cardiovascular or other disease within 6 months prior to the screening visit or during the screening period.
Parallel
INS018_055 tablets
DrugDosage form: Tablets； Frequency of administration: Orally QD. Other Names: Rentosertib
Placebo
DrugDosage Form: Tablet; Frequency of administration: Orally QD.
the annual rate of forced vital capacity (FVC; mL) decline over 52 weeks.
time to first occurrence of any disease progression
including 1) percent predicted forced vital capacity decrease relative to baseline greater than 10%, 2) acute exacerbation of IPF, 3) respiratory-related hospitalization, or 4) death due to respiratory
change from baseline to Week 52 in quantitative computed tomography-derived lung fibrosis burden on high-resolution computed tomography(HRCT)
change from baseline in quality of life (QoL) as measured by the patient-reported outcomes questionnaires using King's Brief Interstitial Lung Disease questionnaire (K BILD)
change from baseline in QoL as measured by the patient-reported outcomes questionnaires using Living with Pulmonary Fibrosis(L-PF)
Incidence of treatment-emergent adverse events(Safety and Tolerability), and clinically significant changes in physical examination,vital signs,safety laboratory test
Clinically significant changes in the 12-lead electrocardiogram(ECG) of ECG QTcF Interval
Clinically significant changes in the 12-lead electrocardiogram(ECG) of ECG Heart Rate
changes from baseline in serum proteome by high throughput proteomic analysis at Weeks 12, 26, and 52
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