INS018_055 for Idiopathic Pulmonary Fibrosis

Recruiting at 37 trial locations

Overseen By Weisheng Chen

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

71 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it allows participants who are already on stable doses of pirfenidone or nintedanib for more than 8 weeks to join. It seems you can continue these medications if they are stable.

Eligibility Criteria

Adults over 40 with Idiopathic Pulmonary Fibrosis (IPF) who meet specific lung function criteria can join this trial. They must have a stable condition and not have had an acute IPF exacerbation in the last 4 months. Smokers or those unwilling to quit, pregnant or nursing women are excluded.

Inclusion Criteria

I have been on a stable dose of pirfenidone or nintedanib for over 8 weeks.

I am 40 years old or older.

I have been diagnosed with IPF according to expert guidelines.

Exclusion Criteria

Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study

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

Abnormal ECG findings

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

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• INS018_055

Trial Overview The study is testing INS018_055, taken orally for up to 12 weeks, against a placebo to see if it's safe and tolerable for adults with IPF. Some participants may also be on stable antifibrotic therapy like pirfenidone or nintedanib.

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 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+