Home › Trials › NCT05975983

Evaluating INS018_055 for Idiopathic Pulmonary Fibrosis

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2 Interventional InSilico Medicine Hong Kong Limited · NCT05975983

This study is testing a new oral medication called INS018_055 to see if it is safe and helps adults with Idiopathic Pulmonary Fibrosis feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment40 (estimated)
Ages40 Years and up
SexAll
SponsorInSilico Medicine Hong Kong Limited Industry-sponsored
Locations12 sites (Birmingham, Alabama and 11 other locations)
Trial IDNCT05975983 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 40 and older with a confirmed diagnosis of Idiopathic Pulmonary Fibrosis who are stable and meet specific pulmonary function criteria.

Not a fit: Patients with acute exacerbations of IPF or those not meeting the pulmonary function criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from Idiopathic Pulmonary Fibrosis.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in the treatment of IPF with other therapies, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic Pulmonary FibrosisPulmonary FibrosisFibrosisPathologic ProcessesLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.