Please sign in to follow a disease.
AI-Designed drug targets scarred lungs in major trial
NCT ID NCT07687459
First seen Jul 07, 2026 · Last updated Sep 18, 2026 · Updated 3 times
Summary
This phase 3 trial tests whether the oral drug rentosertib (INS018_055) can slow lung function decline in adults with idiopathic pulmonary fibrosis (IPF), a progressive lung disease. About 320 participants will receive either rentosertib or a placebo daily for 52 weeks. The main goal is to measure changes in forced vital capacity, a key indicator of lung health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rentosertib (INS018_055)
- What this could lead to
- If successful, rentosertib could slow lung function decline in people with idiopathic pulmonary fibrosis, offering a new treatment option for this serious disease.
- What could go wrong
- This is a phase 3 trial, but results may not show benefit over placebo. The drug could have side effects, and its long-term safety is still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2026
- Expected to finish
-
Oct 2029
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \<80% predicted of normal. 6. Background antifibrotic therapies are allowed, patients may be either: 1. 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. 2. 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. 7. Estimated minimum life expectancy of at least 30 months for non-IPF related disease in the opinion of the investigator. 8. 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. Exclusion criteria: 1. 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). 2. Previous participation in a clinical study with rentosertib (active or placebo). 3. 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. 4. Pulmonary hypertension that is clinically relevant or severe as deemed by the investigator, or other clinically significant pulmonary abnormalities. 5. Unstable cardiovascular or other disease within 6 months prior to the screening visit or during the screening period. 6. 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. 7. Acute exacerbation of IPF within 6 months prior to screening visit and/or during the screening period. 8. 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). 9. Patients with Gilbert's disease 10. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and clinically significant viral hepatitis. 11. 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. 12. Estimated glomerular filtration rate \<60 mL/min/1.73m2 at screening. 13. 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). 14. Patient with a history of lung volume reduction surgery or lung transplant. 15. Current smoker and/or cotinine (smoking) test positive. 16. History of drug abuse, drug use, or alcohol abuse within the past 3 months. 17. Major surgery performed within 3 months prior to screening visit, during the screening period, or have major surgery planned during the study period. 18. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening visit. 19. 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. 20. Patients currently taking endothelin receptor antagonists,phosphodiesterase type 5 inhibitors, soluble guanylate cyclase modulators, prostacyclin analogues and prostanoids, or activin signaling inhibitor. 21. Patients currently on a treatment with nerandomilast within 8 weeks prior to screening visit and during the screening period. 22. Use of any of the following drugs within 2 weeks prior to Visit 1/screening or planned during the duration of the study 1. Strong and moderate cytochrome P450 3A4 or 1A2 inhibitors/inducers 2. Medications associated with substantial risk for prolongation of corrected QT interval. 23. Patients who have consumed grapefruit or grapefruit juice, pomelo, Seville orange or Seville orange-containing products within 48 hours before Day 1. 24. Patients who used hormone replacement therapy in the 4 weeks prior to randomization. No hormone replacement therapy use is allowed during the study. 25. Patients with known hypersensitivity or contraindications to serine/threonine kinase inhibitors. 26. Any condition that would interfere with the interpretation of study assessments or impair study participation. 27. Any physical or psychological conditions or circumstance that, in the opinion of the investigator, may make a patient unsuitable for inclusion or unlikely or unable to complete the study or comply with study procedures and requirements.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Idiopathic pulmonary fibrosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
47 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Affiliated Hangzhou First People's Hospital,School of Medicine, Westlake University
RECRUITINGHangzhou, Zhejiang, China
-
Anhui Chest Hospital
NOT_YET_RECRUITINGHefei, Anhui, China
-
Anhui Provincial Hospital
NOT_YET_RECRUITINGHefei, Anhui, China
-
Beijing Chaoyang Hospital, Capital Medical University
NOT_YET_RECRUITINGBeijing, Beijing Municipality, China
-
Beijing Friendship Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, China
-
Fuzhou University Affiliated Provincial Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, China
-
Hainan General Hospital
RECRUITINGHaikou, Hainan, China
-
Hebei Medical University Third Hospital
NOT_YET_RECRUITINGShijiazhuang, Hebei, China
-
Henan Provincial People's Hospital
NOT_YET_RECRUITINGZhengzhou, Henan, China
-
Introduction of the First Affiliated Hospital of Shandong First Medical University
NOT_YET_RECRUITINGJinan, Shandong, China
-
Jiangxi Provincial People' Hospital
NOT_YET_RECRUITINGNanchang, Jiangxi, China
-
Nanfang Hospital, Southern Medical University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
-
Nanjing Drum Tower Hospital
RECRUITINGNanjing, Jiangsu, China
-
Nanyang First People's Hospital
RECRUITINGNanyang, Henan, China
-
Ningbo Medical Center Lihuili Hospital
NOT_YET_RECRUITINGNingbo, Zhejiang, China
-
Peking Union Medical College Hospital
RECRUITINGBeijing, Beijing Municipality, China
-
Qilu Hospital of Shandong University
NOT_YET_RECRUITINGJinan, Shandong, China
-
Renmin Hospital of Wuhan University
NOT_YET_RECRUITINGWuhan, Hubei, China
-
Shanghai Pulmonary Hospital Affiliated to Tongji University
RECRUITINGShanghai, Shanghai Municipality, China
-
Shanxi Bethune Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, China
-
Shengjing Hospital of China Medical University
NOT_YET_RECRUITINGShenyang, Liaoning, China
-
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, China
-
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, Zhejiang, China
-
The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITINGHohhot, Inner Mongolia, China
-
The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITINGXuzhou, Jiangsu, China
-
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITINGNanning, Guangxi, China
-
The First Affiliated Hospital of Guangzhou Medical University
RECRUITINGGuangzhou, Guangdong, China
-
The First Affiliated Hospital of Ningbo University
NOT_YET_RECRUITINGNingbo, Zhejiang, China
-
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITINGWenzhou, Zhejiang, China
-
The First Affiliated Hospital of Xi'an Medical College
RECRUITINGXi'an, Shaanxi, China
-
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITINGÜrümqi, Xinjiang, China
-
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, China
-
The First Hospital of Jiaxing
NOT_YET_RECRUITINGJiaxing, Zhejiang, China
-
The First People Hospital of Yunnan Province
NOT_YET_RECRUITINGKunming, Yunnan, China
-
The People's Hospital of Anyang City
RECRUITINGAnyang, Henan, China
-
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITINGXi'an, Shaanxi, China
-
The Second Affiliated Hospital of Xiamen Medical College
RECRUITINGXiamen, Fujian, China
-
The Second Hospital of Hebei Medical University
NOT_YET_RECRUITINGShijiazhuang, Hebei, China
-
The Second Hospital of Jilin University
NOT_YET_RECRUITINGChangchun, Jilin, China
-
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITINGChangsha, Hunan, China
-
The Xiangya Hospital of Central South University
NOT_YET_RECRUITINGChangsha, Hunan, China
-
Tianjin Chest Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, China
-
Tianjin Medical University General Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, China
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, China
-
West China Hospital, Sichuan University
NOT_YET_RECRUITINGChengdu, Sichuan, China
-
Yichang Central People's Hospital
NOT_YET_RECRUITINGYichang, Hubei, China
-
Yuncheng Central Hospital
NOT_YET_RECRUITINGYuncheng, Shanxi, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Patients and families build a living database of pulmonary fibrosis
- Can pulmonary fibrosis patients pull hard enough for their inhalers?
- Can a thousand patient records unlock better care for a rare lung disease?
- Sharper CT scans may solve a lung disease diagnostic puzzle
- Can we untangle the overlap of lung diseases? a new study aims to find out
- A blood test that could predict who survives a lung disease crisis?