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INS018_055 for Idiopathic Pulmonary Fibrosis

Phase 2

Recruiting

Research Sponsored by InSilico Medicine Hong Kong Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up following the first dose on day 1 (visit 2) and the last dose during week 12 (visit 6, end of treatment (eot))

Awards & highlights

Study Summary

This trial aims to learn if a new drug is safe & effective for people with IPF. Researchers will measure safety & tolerance of the drug over 12 weeks vs. a placebo.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the side effects of INS018_055 aren't listed here, common ones in trials might include gastrointestinal issues, skin reactions, fatigue, and potential liver enzyme changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ following the first dose on day 1 (visit 2) and the last dose during week 12 (visit 6, end of treatment (eot))

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~following the first dose on day 1 (visit 2) and the last dose during week 12 (visit 6, end of treatment (eot))

This trial's timeline: 3 weeks for screening, Varies for treatment, and following the first dose on day 1 (visit 2) and the last dose during week 12 (visit 6, end of treatment (eot)) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Absolute and relative change in FVC % predicted

Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and metabolites (INS018_063 and INS018_095)

Apparent clearance (CL/F) of INS018_055 and metabolites (INS018_063 and INS018_095)

+16 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: INS018_055Experimental Treatment1 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: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INS018_055

2022

Completed Phase 1

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

InSilico Medicine Hong Kong LimitedLead Sponsor

4 Previous Clinical Trials

280 Total Patients Enrolled

2 Trials studying Idiopathic Pulmonary Fibrosis

138 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Media Library

INS018_055 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05938920 — Phase 2

Idiopathic Pulmonary Fibrosis Research Study Groups: Placebo, INS018_055

Idiopathic Pulmonary Fibrosis Clinical Trial 2023: INS018_055 Highlights & Side Effects. Trial Name: NCT05938920 — Phase 2

INS018_055 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05938920 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the status of enrollment for this clinical experiment?

"Yes, as per the information on clinicaltrials.gov, this investigation is currently looking for individuals to join in June 19th 2023 and last updated July 6th 2023. Sixty participants must be recruited from 10 different medical sites."

Answered by AI

Has the FDA sanctioned INS018_055 for public use?

"The safety of INS018_055 was evaluated as a 2 on our internal scale since there is some evidence confirming its security, yet no clinical data to back up its effectiveness."

Answered by AI

What is the headcount of participants involved in this trial?

"To complete this trial, 60 participants meeting the predetermined selection criteria must be enrolled. These clinical trials are located at Florida Lung Asthma and Sleep Specialist - Celeration in Celebration, Florida and Southeastern Research Center in Winston-Salem, North carolina."

Answered by AI

Are there numerous medical facilities in the US engaging with this clinical trial?

"Patients have the option of enrolling in this trial at Florida Lung Asthma and Sleep Specialist - Celeration, Southeastern Research Center, or OU Health Sciences Centre - OU Health Physicians-Cardiology Clinic. In addition to these three sites, there are seven other medical centres participating in recruitment for this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

2023. "Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05938920.

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