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Idiopathic Pulmonary FibrosisPhase 3NCT07687459

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

A Phase 3 study testing INS018_055 tablets in people with Idiopathic Pulmonary Fibrosis, run by InSilico Medicine Hong Kong Limited at 47 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
INS018_055 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
47 sitesChina
Study dates
9 Sep 2026to 30 Oct 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • FEV1/FVC ≥0.7
  • DLCO (corrected for hemoglobin) ≥25% and <80% predicted of normal.
  • Background antifibrotic therapies are allowed, patients may be either:
  • on monotherapy with nintedanib or pirfenidone must have been on a stable therapy for at least 12 weeks prior to 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.
  • 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.

Who cannot join

  • 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.
  • 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.
Show all 28Show fewer
  • Patients with underlying chronic liver disease (Child Pugh A, B, or C hepatic impairment), and patients with non-alcoholic steatohepatitis.
  • Patients with hyperbilirubinemia or Gilbert's syndrome.
  • 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 ≥1.0 × 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.
  • Patients (female) who used hormone replacement therapy in the 4 weeks prior to randomization. No hormone replacement therapy use is allowed during the study (for female)
  • Patients with known hypersensitivity or contraindications to serine/threonine kinase inhibitors.
  • Any condition that would interfere with the interpretation of study assessments or impair study participation.
  • 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.

Trial locations and contacts

47 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qinhan Chen contact

+86 021-50831718

Insilico-Clinicaltrial@insilico.ai

47 sites in 1 country

China47 sites, 47 recruiting

  • The People's Hospital of Anyang City

    Anyang, Henan

    Recruiting

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Not yet recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

    Recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin

    Not yet recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Not yet recruiting

  • The Xiangya Hospital of Central South University

    Changsha, Hunan

    Not yet recruiting

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

    Chengdu, Sichuan

    Not yet recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

    Not yet recruiting

  • Fuzhou University Affiliated Provincial Hospital

    Fuzhou, Fujian

    Not yet recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

    Not yet recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Recruiting

  • Hainan General Hospital

    Haikou, Hainan

    Recruiting

  • Affiliated Hangzhou First People's Hospital,School of Medicine, Westlake University

    Hangzhou, Zhejiang

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Not yet recruiting

  • Anhui Chest Hospital

    Hefei, Anhui

    Not yet recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui

    Not yet recruiting

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

    Not yet recruiting

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang

    Not yet recruiting

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

    Jinan, Shandong

    Not yet recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    Not yet recruiting

  • The First People Hospital of Yunnan Province

    Kunming, Yunnan

    Not yet recruiting

  • Jiangxi Provincial People' Hospital

    Nanchang, Jiangxi

    Not yet recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Not yet recruiting

  • Nanyang First People's Hospital

    Nanyang, Henan

    Recruiting

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang

    Not yet recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang

    Not yet recruiting

  • Shanghai Pulmonary Hospital Affiliated to Tongji University

    Shanghai, Shanghai Municipality

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

    Not yet recruiting

  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei

    Not yet recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Not yet recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

    Not yet recruiting

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality

    Not yet recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

    Not yet recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

    Not yet recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Not yet recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

    Not yet recruiting

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

    Wuhan, Hubei

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Medical College

    Xi'an, Shaanxi

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

    Recruiting

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Not yet recruiting

  • Yichang Central People's Hospital

    Yichang, Hubei

    Not yet recruiting

  • Yuncheng Central Hospital

    Yuncheng, Shanxi

    Not yet recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Not yet recruiting

Other trials in China

About this study

Official title: 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)

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.

Being tested
INS018_055 tablets, Placebo
Keywords
Idiopathic Pulmonary Fibrosis (IPF), serine/threonine kinase TNIK
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INS018_055 tabletsDrug

    Dosage form: Tablets； Frequency of administration: Orally QD. Other Names: Rentosertib

  • PlaceboDrug

    Dosage Form: Tablet; Frequency of administration: Orally QD.

Study groups in NCT07687459
Study groupRoleWhat they receive
ActiveExperimentalPatients assigned will receive ISN018_055 tablets orally QD for 52 weeks
Receives: Drug: INS018_055 tablets
PlaceboPlacebo comparatorPatients assigned will receive matching placebo orally QD for 52 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the annual rate of forced vital capacity (FVC; mL) decline over 52 weeks.

    Measured: Weeks 0,4,12,26,39,52

Secondary outcomes (5)

  1. 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

    Measured: up to 52 weeks

  2. change from baseline to Week 52 in quantitative computed tomography-derived lung fibrosis burden on high-resolution computed tomography(HRCT)

    Measured: week 52

  3. 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)

    Measured: Weeks 0,4,12,26,39,52

  4. change from baseline in QoL as measured by the patient-reported outcomes questionnaires using Living with Pulmonary Fibrosis(L-PF)

    Measured: Weeks 0,4,12,26,39,52

  5. change from baseline in hemoglobin-corrected diffusing capacity of the lung for carbon monoxide (DLCO) over 52 weeks

    Measured: Weeks 0, 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start9 Sep 2026
  3. Primary completion30 Oct 2029 (estimated)
  4. Study completion30 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07687459
Sponsor's protocol ID
INS018-055-301
Status last verified
Jun 2026
First submitted
22 Jun 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing INS018_055 tablets in people with Idiopathic Pulmonary Fibrosis, run by InSilico Medicine Hong Kong Limited at 47 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qinhan Chen (+86 021-50831718, Insilico-Clinicaltrial@insilico.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the annual rate of forced vital capacity (FVC; mL) decline over 52 weeks. (time frame: Weeks 0,4,12,26,39,52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07687459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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