INS018_055 for Idiopathic Pulmonary Fibrosis

Recruiting at 13 trial locations

Overseen By Carol Salter, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: InSilico Medicine Hong Kong Limited

Must be taking: Antifibrotics

Disqualifiers: Acute IPF exacerbation, Smoking, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, INS018_055, for individuals with Idiopathic Pulmonary Fibrosis (IPF), a lung disease that makes breathing difficult. Researchers aim to determine the treatment's safety and compare it to a placebo (a pill with no active medicine) over 12 weeks. Participants will receive either a low or high dose of the treatment or a placebo. Suitable candidates for this trial are those diagnosed with IPF and have a stable condition without recent flare-ups. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you can join if you have been on a stable regimen of pirfenidone or nintedanib for at least 8 weeks before the trial starts.

Is there any evidence suggesting that INS018_055 is likely to be safe for humans?

Research shows that INS018_055 has promising safety results. An earlier study found this drug to be safe and well-tolerated by patients over 12 weeks, with no significant side effects. This suggests that INS018_055 might be safe for individuals with idiopathic pulmonary fibrosis (IPF), a serious lung disease. The drug targets a specific protein linked to the thickening and scarring of lung tissue and was developed using advanced technology. While more research is needed, these early findings suggest it could be a safe treatment option for IPF patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for idiopathic pulmonary fibrosis, which typically include nintedanib and pirfenidone, INS018_055 offers a potential new approach by targeting the disease differently. Researchers are excited about INS018_055 because it might work by modulating a unique pathway involved in the disease's progression, which could lead to better outcomes. Additionally, the treatment is being explored in different dosing regimens, potentially offering more flexibility and improved patient adherence. This fresh perspective on treatment could bring new hope to patients who have limited options.

What evidence suggests that INS018_055 might be an effective treatment for Idiopathic Pulmonary Fibrosis?

Research has shown that INS018_055, a new drug, may help treat Idiopathic Pulmonary Fibrosis (IPF), a lung disease. In earlier studies, this drug improved lung function in patients and proved safe in animal tests. It targets fibrosis, the thickening and scarring of lung tissue, a major issue in IPF. Early results are promising, suggesting that INS018_055 could slow the progression of this lung disease. Although more research is needed, these findings offer hope for people with IPF. Participants in this trial will receive either INS018_055 or a placebo to further evaluate its effectiveness and safety. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults over 40 with Idiopathic Pulmonary Fibrosis (IPF) can join this trial. They must have a certain level of lung function and be in stable condition, as confirmed by medical tests. If they're taking specific IPF medications, these should be unchanged for at least 8 weeks before the study starts. Pregnant or nursing women, smokers who haven't quit for 6 months, and those with recent severe IPF flare-ups or abnormal heart readings cannot participate.

Inclusion Criteria

My health is stable enough for me to join a study, based on recent medical checks.

Your lung function test shows a specific ratio of airflow that is above a certain number.

Meeting all of the following criteria during the screening period:

Exclusion Criteria

I have had a sudden worsening of my lung condition within the last 4 months.

Your heart's electrical activity on an ECG is not normal.

I am not pregnant or nursing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INS018_055 or placebo orally for up to 12 weeks to evaluate safety and tolerability

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INS018_055
• Placebo

Trial Overview The trial is testing INS018_055 taken orally against a placebo to see if it's safe and tolerable when given for up to 12 weeks to adults with IPF. The main goal is to compare side effects between the new drug and the placebo.

How Is the Trial Designed?

Group I: INS018_055 Experimental Treatment 1 Intervention

INS018\_055 is administered once daily up to 12 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo is administered once daily up to 12 weeks

INS018_055 is already approved in United States, China for the following indications:

Approved in United States as INS018_055 for:

• Idiopathic Pulmonary Fibrosis (IPF)

Approved in China as INS018_055 for:

• Idiopathic Pulmonary Fibrosis (IPF)

Who Is Running the Clinical Trial?

InSilico Medicine Hong Kong Limited

Lead Sponsor

Trials

9

Recruited

1,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05938920

NCT05938920 | Study Evaluating INS018_055 ... 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 ...

2. insilico.com insilico.com/blog/first_phase2

First Generative AI Drug Begins Phase II Trials with Patients They chose the 55th molecule which showed promise in improving fibrosis and good safety profile in mouse models. Bringing efficiency to drug ...

3. pulmonaryfibrosis.org pulmonaryfibrosis.org/patients-caregivers/medical-and-support-resources/clinical-trials-education-center/pipeline/drug/idiopathic-pulmonary-fibrosis/ism001-055-(ins018_055)

INS018_055 Insilico Medicine Announces Positive Topline Results of ISM001-055 for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) Developed Using Generative AI. Learn ...

4. atsjournals.org atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A2904

INS018-055, A Novel Traf2- and NCK-interacting Kinase ... INS018-055, A Novel Traf2- and NCK-interacting Kinase (TNIK) Inhibitor, Improves Lung Function in Patients With Idiopathic Pulmonary Fibrosis: Results From a ...

5. nature.com nature.com/articles/s41587-024-02143-0

A small-molecule TNIK inhibitor targets fibrosis in ... Idiopathic pulmonary fibrosis (IPF) is an aggressive interstitial lung disease with a high mortality rate. Putative drug targets in IPF have ...