INS018_055 for Idiopathic Pulmonary Fibrosis

Recruiting at10 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: InSilico Medicine Hong Kong Limited

Must be taking: Antifibrotics

Disqualifiers: Acute IPF exacerbation, Smoking, Pregnancy, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new oral medication, INS018_055, in adults with Idiopathic Pulmonary Fibrosis (IPF). It aims to see if the medication is safe and well-tolerated over a few months.

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.

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• INS018_055 (Other)
• Placebo (Other)

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.

Participant Groups

Group I: INS018_055 Experimental Treatment 1 Intervention

Group 1: INS018_055 once daily up to 12 weeks, low dose Group 2: INS018_055 twice daily up to 12 weeks, low dose Group 3: INS018_055 once daily up to 12 weeks, high dose

Group II: Placebo Placebo Group 1 Intervention

Group 4: Placebo once or twice daily up to 12 weeks

INS018_055 is already approved in China for the following indications:

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+