Status:
RECRUITING
Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
InSilico Medicine Hong Kong Limited
Conditions:
Idiopathic Pulmonary Fibrosis (IPF)
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The purpose of this revised Phase IIa study is to demonstrate safety of INS018\_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).
Detailed Description
Idiopathic pulmonary fibrosis is a fatal lung disease characterized by reduced quality of life (QoL) and a median survival of 3 to 4 years. While current standard of care (SoC) treatments including pi...
Eligibility Criteria
Inclusion
- Male or female patients aged ≥40 years based on the date of the written informed consent form
- Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
- 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
- Meeting all of the following criteria during the screening period:
- FVC ≥40% predicted normal
- DLCO corrected for Hgb ≥25% and \<80% predicted normal
- Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio \>0.7 based on pre-bronchodilator value
Exclusion
- Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by the investigator
- Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
- Female patients who are pregnant or nursing
- Abnormal ECG findings
Key Trial Info
Start Date :
February 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05975983
Start Date
February 8 2024
End Date
February 28 2026
Last Update
November 12 2025
Active Locations (12)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
3
Keck School of Medicine of USC
Los Angeles, California, United States, 90033
4
Florida Lung Asthma and Sleep Specialist
Celebration, Florida, United States, 34747-1818