Idiopathic Pulmonary Fibrosis (IPF)Phase 2NCT05938920
Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing INS018_055 in people with Idiopathic Pulmonary Fibrosis (IPF), run by InSilico Medicine Hong Kong Limited at 22 sites in China.
Trial summary
The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic Pulmonary Fibrosis (IPF). The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- INS018_055
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 22 sitesChina
- Study dates
- 19 Jun 2023to 8 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female patients aged ≥40 years based on the date of the written informed consent form
- Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
- In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
- Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for > 8 weeks prior to Visit 1
- Meeting all of the following criteria during the screening period:
- FVC ≥40% predicted of normal
- DLCO corrected for Hgb ≥25% and <80% predicted of normal.
- forced expiratory volume in the first second/FVC (FEV1/FVC) ratio >0.7 based on pre-bronchodilator value
Who cannot join
- Acute IPF exacerbation within 4 months prior to Visit 1 and/or during the screening period, as determined by the investigator
- Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
- Female patients who are pregnant or nursing
- Abnormal ECG findings
- Other protocol inclusion and exclusion criteria may apply.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100041
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
The West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Hainan General Hospital
Haikou, Hainan, 570311
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Anhui Chest Hospital
Hefei, Anhui, 230031
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Qilu Hospital of Shandong University
Jinan, Shandong, 250013
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Zhongshan hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 201800
The Shengjing Hospital of China medical university
Shenyang, Liaoning, 110004
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300052
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)
The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic Pulmonary Fibrosis (IPF).
The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- INS018_055, Placebo
- Keywords
- Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Fibrosis, Pathologic Processes, Lung Diseases, Interstitial, Lung Diseases, Respiratory Tract Diseases
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis, Pathologic Processes, Lung Diseases, Interstitial, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INS018_055Drug
Pharmaceutical formulation: Capsules
Mode of Administration: Oral
PlaceboDrug
Pharmaceutical formulation: Capsules
Mode of Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| INS018_055 30 mg QD | Experimental | Group 1: INS018_055 once daily up to 12 weeks, low dose Receives: Drug: INS018_055 |
| INS018_055 30 mg BID | Experimental | Group 2: INS018_055 twice daily up to 12 weeks, low dose Receives: Drug: INS018_055 |
| INS018_055 60 mg QD | Experimental | Group 3: INS018_055 once daily up to 12 weeks, high dose Receives: Drug: INS018_055 |
| Placebo | Placebo comparator | Group 4: Placebo once or twice daily up to 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)
TEAEs were either events with start date on or after the start of the Treatment Period and up to 17 days after EOT (end of treatment), or events with start date prior to the start of the Treatment Period whose severity worsened on or after the start of the Treatment Period and up to 17 days after EOT.
CTCAE=Common Terminology Criteria for Adverse Events
Measured: From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)
Secondary outcomes (4)
Relative Change From Baseline in Forced Vital Capacity (FVC)
Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.
Measured: Week 0/Visit 2 up to Week 12
Absolute Change From Baseline in FVC in L
Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.
Measured: Week 0/Visit 2 up to Week 12
Absolute Change in FVC % Predicted
Absolute change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment
Measured: Week 0/Visit 2 up to Week 12
Relative Change in FVC % Predicted
Relative change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment
Measured: Week 0/Visit 2 up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start19 Jun 2023
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSilico Medicine Hong Kong Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938920
- Sponsor's protocol ID
- INS018-055-003
- Status last verified
- Dec 2025
- First submitted
- 28 Jun 2023
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu Z, Ren F, Wang P, Cao J, Tan C, Ma D, Zhao L, Dai J, Ding Y, Fang H, Li H, Liu H, Luo F, Meng Y, Pan P, Xiang P, Xiao Z, Rao S, Satler C, Liu S, Lv Y, Zhao H, Chen S, Cui H, Korzinkin M, Gennert D, Zhavoronkov A. A generative AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis: a randomized phase 2a trial. Nat Med. 2025 Aug;31(8):2602-2610. doi: 10.1038/s41591-025-03743-2. Epub 2025 Jun 3.
PubMed 40461817
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT05938920
- Acronym / sponsor ID
- INS018-055-003
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Fibrosis, Pathologic Processes, Lung Diseases, Interstitial, Lung Diseases, Respiratory Tract Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- InSilico Medicine Hong Kong LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic Pulmonary Fibrosis (IPF).
The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| INS018_055 30 mg QD | Experimental | Drug: INS018_055Group 1: INS018_055 once daily up to 12 weeks, low dose |
| INS018_055 30 mg BID | Experimental | Drug: INS018_055Group 2: INS018_055 twice daily up to 12 weeks, low dose |
| INS018_055 60 mg QD | Experimental | Drug: INS018_055Group 3: INS018_055 once daily up to 12 weeks, high dose |
| Placebo | Placebo comparator | Drug: PlaceboGroup 4: Placebo once or twice daily up to 12 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients aged ≥40 years based on the date of the written informed consent form
- Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
- In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
- Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for > 8 weeks prior to Visit 1
- Meeting all of the following criteria during the screening period:
Key exclusion criteria (5 listed)
- Acute IPF exacerbation within 4 months prior to Visit 1 and/or during the screening period, as determined by the investigator
- Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
- Female patients who are pregnant or nursing
- Abnormal ECG findings
- Other protocol inclusion and exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INS018_055Pharmaceutical formulation: Capsules Mode of Administration: Oral | Drug | INS018_055 30 mg BID, INS018_055 30 mg QD, INS018_055 60 mg QD |
| PlaceboPharmaceutical formulation: Capsules Mode of Administration: Oral | Drug | Placebo |
Primary outcome
Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)
Time frame: From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)
TEAEs were either events with start date on or after the start of the Treatment Period and up to 17 days after EOT (end of treatment), or events with start date prior to the start of the Treatment Period whose severity worsened on or after the start of the Treatment Period and up to 17 days after EOT. CTCAE=Common Terminology Criteria for Adverse Events
4 secondary outcomes
Relative Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Week 0/Visit 2 up to Week 12
Absolute Change From Baseline in FVC in L
Time frame: Week 0/Visit 2 up to Week 12
Absolute Change in FVC % Predicted
Time frame: Week 0/Visit 2 up to Week 12
Relative Change in FVC % Predicted
Time frame: Week 0/Visit 2 up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40461817Xu Z, Ren F, Wang P, Cao J, Tan C, Ma D, Zhao L, Dai J, Ding Y, Fang H, Li H, Liu H, Luo F, Meng Y, Pan P, Xiang P, Xiao Z, Rao S, Satler C, Liu S, Lv Y, Zhao H, Chen S, Cui H, Korzinkin M, Gennert D, Zhavoronkov A. A generative AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis: a randomized phase 2a trial. Nat Med. 2025 Aug;31(8):2602-2610. doi: 10.1038/s41591-025-03743-2. Epub 2025 Jun 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INS018_055 in people with Idiopathic Pulmonary Fibrosis (IPF), run by InSilico Medicine Hong Kong Limited at 22 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE) (time frame: From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)). 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 NCT05938920, which also lists 1 linked publication.
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 11 Dec 2025.