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Idiopathic Pulmonary Fibrosis (IPF)Phase 2NCT05975983

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

A Phase 2 study testing INS018_055 in people with Idiopathic Pulmonary Fibrosis (IPF), run by InSilico Medicine Hong Kong Limited at 12 sites in United States.

Recruiting

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

Sites and contacts
Official record
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Trial summary

The purpose of this revised Phase IIa study is to demonstrate safety of INS018_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF). 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
40 participants
Where
12 sitesUnited States
Study dates
8 Feb 2024to 28 Feb 2026
Phase
Phase 2
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

  • 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
  • Meeting all of the following criteria during the screening period:
  • FVC ≥40% predicted normal
  • DLCO corrected for Hgb ≥25% and <80% predicted 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 Day 1, 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

Trial locations and contacts

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

Monique Duncan contact

+86 18817554306

Insilico-Clinicaltrial@insilico.ai

Carol Salter, MD, PhD contact

Insilico-Clinicaltrial@insilico.ai

12 sites in 1 country

United States12 sites, 12 recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Recruiting

  • Florida Lung Asthma and Sleep Specialist

    Celebration, Florida, 34747-1818

    Recruiting

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina, 29201-2953

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235-6243

    Recruiting

  • Keck School of Medicine of USC

    Los Angeles, California, 90033

    Recruiting

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas, 75069-1898

    Recruiting

  • Research Centers of America

    McKinney, Texas, 75071

    Recruiting

  • University of Oklahoma Health Sciences Center (OUHSC)

    Oklahoma City, Oklahoma, 73104-5417

    Recruiting

  • Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando

    Orlando, Florida, 32803-5727

    Recruiting

  • Temple University Hospital-Temple Lung Center

    Philadelphia, Pennsylvania, 19140

    Recruiting

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

    Recruiting

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103-4007

    Recruiting

Other trials in United States

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 purpose of this revised Phase IIa study is to demonstrate safety of INS018_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).

Read the detailed description

Idiopathic pulmonary fibrosis is a fatal lung disease characterized by reduced quality of life (QoL) and a median survival of 3 to 4 years. While current standard of care (SoC) treatments including pirfenidone and nintedanib slow disease progression, they are not curative and poorly tolerated due to their toxicity profiles. To address the need for new treatments in IPF, InSilico Medicine is developing INS018_055, a potent inhibitor of the serine/threonine kinase Traf2- and Nckinteracting kinase (TNIK).

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: Tablet

    Mode of Administration: Oral

  • PlaceboDrug

    Pharmaceutical formulation: Tablet

    Mode of Administration: Oral

Study groups in NCT05975983
Study groupRoleWhat they receive
INS018_055ExperimentalINS018_055 is administered once daily up to 12 weeks
Receives: Drug: INS018_055
PlaceboPlacebo comparatorPlacebo is administered once 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.

  1. Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE)

    Measured: Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))

Secondary outcomes (19)

  1. Maximum plasma concentration (Cmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

    Measured: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

  2. Time to reach maximum plasma concentration (Tmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

    Measured: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

  3. Area under the plasma concentration-time curve from time zero to dosing interval τ (AUC0-τ) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

    Measured: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

  4. Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

    Measured: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

  5. Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

    Measured: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

  6. Terminal elimination half-life (t1/2) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

    Measured: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

  7. Terminal elimination rate constant (λz) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

    Measured: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

  8. Apparent clearance (CL/F) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

    Measured: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

  9. Apparent volume of distribution (Vz/F) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

    Measured: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

  10. Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and its major metabolites (INS018_063 and INS018_095)

    Measured: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

  11. Trough plasma concentration (Ctrough) of INS018_055 and its major metabolites (INS018_063 and INS018_095)

    Measured: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 8, End of Treatment (EOT))

  12. Relative change in Forced Vital Capacity (FVC) in mL

    Measured: Week 0/Visit 2 up to Week 12

  13. Percentage change in FVC in mL

    Measured: Week 0/Visit 2 up to Week 12

  14. Absolute and relative change in FVC % predicted

    Measured: Week 0/Visit 2 up to Week 12

  15. Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted

    Measured: Week 0/Visit 2 to Week 12

  16. Change in Leicester Cough Questionnaire (LCQ)

    Measured: Week 0 to Week 4, 8 and 12

  17. Change in 6-Minute Walk Distance (6MWD) in meters

    Measured: Week 0 to Week 12

  18. Number of acute IPF exacerbations

    Measured: Week 0 up to Week 12

  19. Number of days hospitalized for acute IPF exacerbations

    Measured: Week 0 to up Week 12

Timeline

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

  1. First posted4 Aug 2023
  2. Study start8 Feb 2024
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion28 Feb 2026 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05975983
Sponsor's protocol ID
INS018-055-004
Status last verified
Nov 2025
First submitted
27 Jul 2023
Last updated
12 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 12 sites in United States.

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 7 inclusion and 4 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 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. 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?

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 Monique Duncan (+86 18817554306, Insilico-Clinicaltrial@insilico.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE) (time frame: Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))). 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 NCT05975983.

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 12 Nov 2025.

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