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AI-Designed drug targets scarred lungs in major trial

NCT ID NCT07687459

Disease control Sponsor: InSilico Medicine Hong Kong Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

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.

Expected to start

Aug 2026

An estimate. Start dates often move.

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

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.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    47 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    Hangzhou, Zhejiang, China

  • 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

  • Fuzhou University Affiliated Provincial Hospital

    Fuzhou, Fujian, China

  • Hainan General Hospital

    Haikou, Hainan, China

  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei, China

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, China

  • Introduction of the First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong, China

  • Jiangxi Provincial People' Hospital

    Nanchang, Jiangxi, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, China

  • Nanyang First People's Hospital

    Nanyang, Henan, China

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, China

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, China

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, China

  • Shanghai Pulmonary Hospital Affiliated to Tongji University

    Shanghai, Shanghai Municipality, China

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, China

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan, China

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital of Xi'an Medical College

    Xi'an, Shaanxi, China

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, China

  • The First People Hospital of Yunnan Province

    Kunming, Yunnan, China

  • The People's Hospital of Anyang City

    Anyang, Henan, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, China

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, China

  • The Second Hospital of Jilin University

    Changchun, Jilin, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • The Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, China

  • Yichang Central People's Hospital

    Yichang, Hubei, China

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, China

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