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)
1 other identifier
interventional
320
1 country
47
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2026
Typical duration for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2026
CompletedFirst Posted
Study publicly available on registry
July 7, 2026
CompletedStudy Start
First participant enrolled
August 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2029
Study Completion
Last participant's last visit for all outcomes
October 30, 2029
July 7, 2026
June 1, 2026
3.2 years
June 22, 2026
July 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the annual rate of forced vital capacity (FVC; mL) decline over 52 weeks.
Weeks 0,4,12,26,39,52
Secondary Outcomes (5)
time to first occurrence of any disease progression
up to 52 weeks
change from baseline to Week 52 in quantitative computed tomography-derived lung fibrosis burden on high-resolution computed tomography(HRCT)
week 52
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)
Weeks 0,4,12,26,39,52
change from baseline in QoL as measured by the patient-reported outcomes questionnaires using Living with Pulmonary Fibrosis(L-PF)
Weeks 0,4,12,26,39,52
change from baseline in hemoglobin-corrected diffusing capacity of the lung for carbon monoxide (DLCO) over 52 weeks
Weeks 0, 52
Other Outcomes (6)
Incidence of treatment-emergent adverse events(Safety and Tolerability), and clinically significant changes in physical examination,vital signs,safety laboratory test
up to 56 weeks
Clinically significant changes in the 12-lead electrocardiogram(ECG) of ECG QTcF Interval
Weeks 0,2,4,8,12,26,39,52
Clinically significant changes in the 12-lead electrocardiogram(ECG) of ECG Heart Rate
Weeks 0,2,4,8,12,26,39,52
- +3 more other outcomes
Study Arms (2)
Active
EXPERIMENTALPatients assigned will receive ISN018\_055 tablets orally QD for 52 weeks
Placebo
PLACEBO COMPARATORPatients assigned will receive matching placebo orally QD for 52 weeks
Interventions
Dosage form: Tablets； Frequency of administration: Orally QD. Other Names: Rentosertib
Eligibility Criteria
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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
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
Jiangxi Provincial People' Hospital
Nanchang, Jiangxi, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Medical College
Xi'an, Shaanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Introduction of the First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanghai Pulmonary Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First People Hospital of Yunnan Province
Kunming, Yunnan, China
Affiliated Hangzhou First People's Hospital,School of Medicine, Westlake University
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2026
First Posted
July 7, 2026
Study Start (Estimated)
August 30, 2026
Primary Completion (Estimated)
October 30, 2029
Study Completion (Estimated)
October 30, 2029
Last Updated
July 7, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share