Study Evaluation Rentosertib (INS018_055) Administered Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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.

Key facts

Study ID

NCT07687459

Run by

InSilico Medicine Hong Kong Limited

People needed

320

Starts

2026-08-30

Expected to finish

2029-10-30

Last updated by the study team

2026-07-07

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Meet all the following criteria during the screening period:
• FVC ≥45% predicted of normal
• FEV1/FVC ≥0.7
• DLCO (corrected for hemoglobin) ≥25% and <80% predicted of normal.
• Background antifibrotic therapies are allowed, patients may be either:
• on a stable therapy with nintedanib or pirfenidone as monotherapy for at least 12 weeks prior to screening visit and during the screening period and are planning to stay on this background treatment after randomization.
• not on a treatment with nintedanib or pirfenidone for at least 8 weeks prior to screening visit and during the screening period and do not plan to start or restart antifibrotic therapy.
• Estimated minimum life expectancy of at least 30 months for non-IPF related disease in the opinion of the investigator.
• Male patients and female patients of childbearing potential agree to use highly effective contraception/preventive exposure measures from the time of the first dose of the study drug (for the male patient) or the signing of the ICF (for the female patient) until 90 days after the last dose of the study drug.

You may not qualify if…

• 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).
• Previous participation in a clinical study with rentosertib (active or placebo).
• 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.
• Presence of other clinically significant airway disease that may, in the opinion of the investigator, impact the study safety or efficacy objectives, such as asthma, bronchiectasis, cystic fibrosis, active aspergillosis, active tuberculosis, or other serious concomitant respiratory disorder other than pulmonary fibrosis.
• Acute exacerbation of IPF within 6 months prior to screening visit and/or during the screening period.
• Patients with underlying chronic liver disease (Child Pugh A, B, or C hepatic impairment), hepatic steatosis (including non-alcoholic steatohepatitis and/or other types of fatty liver diseases).
• Patients with Gilbert's disease
• Relevant chronic or acute infections including human immunodeficiency virus (HIV) and clinically significant viral hepatitis.
• Aspartate aminotransferase or alanine aminotransferase ≥1.5 × upper limit of normal (ULN), and/or total bilirubin ≥1.5 × ULN, and/or gamma glutamyl transferase ≥3 × ULN, and/or alkaline phosphatase ≥1.5 × ULN at screening.
• Estimated glomerular filtration rate <60 mL/min/1.73m2 at screening.
• Patient with 12-lead ECG demonstrating corrected QT interval by Fridericia (QTcF) >450 ms for males and >470 ms for females at screening (Visit 1).
• Patient with a history of lung volume reduction surgery or lung transplant.
• Current smoker and/or cotinine (smoking) test positive.
• History of drug abuse, drug use, or alcohol abuse within the past 3 months.
• Major surgery performed within 3 months prior to screening visit, during the screening period, or have major surgery planned during the study period.
• Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening visit.
• Use of any of the following therapies within 4 weeks prior to screening visit and during the screening period or planned during the study: warfarin and immunosuppressive medications.
• Patients currently taking endothelin receptor antagonists,phosphodiesterase type 5 inhibitors, soluble guanylate cyclase modulators, prostacyclin analogues and prostanoids, or activin signaling inhibitor.
• Patients currently on a treatment with nerandomilast within 8 weeks prior to screening visit and during the screening period.
• Use of any of the following drugs within 2 weeks prior to Visit 1/screening or planned during the duration of the study
• Strong and moderate cytochrome P450 3A4 or 1A2 inhibitors/inducers
• Medications associated with substantial risk for prolongation of corrected QT interval.
• Patients who have consumed grapefruit or grapefruit juice, pomelo, Seville orange or Seville orange-containing products within 48 hours before Day 1.

Where it is running

• Anhui Chest Hospital — Hefei, Anhui, China
• Anhui Provincial Hospital — Hefei, Anhui, China
• Beijing Chaoyang Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
• Fuzhou University Affiliated Provincial Hospital — Fuzhou, Fujian, China
• The Second Affiliated Hospital of Xiamen Medical College — Xiamen, Fujian, China
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
• Hainan General Hospital — Haikou, Hainan, China
• Hebei Medical University Third Hospital — Shijiazhuang, Hebei, China
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• The People's Hospital of Anyang City — Anyang, Henan, China
• Nanyang First People's Hospital — Nanyang, Henan, China
• Henan Provincial People's Hospital — Zhengzhou, Henan, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• Yichang Central People's Hospital — Yichang, Hubei, China
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China
• The Xiangya Hospital of Central South University — Changsha, Hunan, China
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China

Full record on ClinicalTrials.gov

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