71 Participants Needed

INS018_055 for Idiopathic Pulmonary Fibrosis

Recruiting at 37 trial locations
YL
FE
YT
LY
CC
BZ
WC
Overseen ByWeisheng Chen
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: InSilico Medicine Hong Kong Limited
Must be taking: Antifibrotics
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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.
See 2 more

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
See 1 more

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

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
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: INS018_055Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

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

🇺🇸
Approved in United States as INS018_055 for:
🇨🇳
Approved in China as INS018_055 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

InSilico Medicine Hong Kong Limited

Lead Sponsor

Trials
9
Recruited
1,100+
Unbiased ResultsWe believe in providing patients with all the options.
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