Evaluating INS018_055 for Idiopathic Pulmonary Fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and tolerability of INS018_055, an oral medication, in adults diagnosed with Idiopathic Pulmonary Fibrosis (IPF). Participants will receive either the investigational drug or a placebo for a duration of up to 12 weeks. The study will include adults aged 40 and older who meet specific pulmonary function criteria and are in a stable condition. The trial will help determine if INS018_055 can provide a new treatment option for patients with IPF.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patients aged ≥40 years based on the date of the written informed consent form
2. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
3. In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
4. Meeting all of the following criteria during the screening period:

   1. FVC ≥40% predicted normal
   2. DLCO corrected for Hgb ≥25% and \<80% predicted normal
   3. Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio \>0.7 based on pre-bronchodilator value

Exclusion Criteria:

1. Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by the investigator
2. Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
3. Female patients who are pregnant or nursing
4. Abnormal ECG findings

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• HonorHealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• Keck School of Medicine of USC
  Los Angeles, California, United States Recruiting
• Florida Lung Asthma and Sleep Specialist
  Celebration, Florida, United States Recruiting
• Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
  Orlando, Florida, United States Recruiting
• Southeastern Research Center
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Monique Duncan
• Email: Insilico-Clinicaltrial@insilico.ai
• Phone: +86 18817554306

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nerandomilast in IPF and Progressive Fibrosis: Real-World Data

  This study tests whether nerandomilast helps slow lung function decline in adults with IPF or progressive fibrotic lung disease in routine clinical care.

  Recruiting at 4 sites Tel Aviv Medical Center · Ashkelon and 3 other locations · NCT07919015

• Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs

  This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.

  Recruiting Istituto Clinico Humanitas · Rozzano, Italy · NCT07790614

• Finger vs. Earlobe Pulse Oximetry During a 6-Minute Walk Test in ILD

  This study tests whether finger or earlobe pulse oximetry gives the same oxygen saturation readings during a 6-minute walk in people with interstitial lung disease.

  Recruiting Hospital de Granollers · Granollers, Spain · NCT07723872

• Biomarker clues for COPD, IPF, and lung cancer

  This study tests whether inflammation, immune, genetic, and epigenetic markers at enrollment can explain how COPD, IPF, or lung cancer present and behave, in order to see if these markers can predict outcomes over a year.

  Recruiting Fondazione Don Carlo Gnocchi ETS · Milan, Milan · NCT07707245

• Inhaled nintedanib powder for IPF in adults

  This study tests whether an inhaled form of nintedanib can safely help adults with idiopathic pulmonary fibrosis.

  Recruiting Phase 2 Mannkind Corporation · Windsor, Ontario · NCT07679893

• AZD8965 in IPF: see if three doses help IPF patients

  This Phase IIb study tests three doses of AZD8965 against placebo in people with idiopathic pulmonary fibrosis, including those who are and aren’t on antifibrotic therapy.

  Recruiting at 103 sites Phase 2 AstraZeneca · Birmingham, Alabama and 197 other locations · NCT07652658

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.