Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis (IPF)

In brief

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).

Key facts

Study ID

NCT05975983

Run by

InSilico Medicine Hong Kong Limited

People needed

40

Starts

2024-02-08

Expected to finish

2026-02-28

Last updated by the study team

2025-11-12

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• HonorHealth Research Institute — Scottsdale, Arizona, United States (enrolling)
• Keck School of Medicine of USC — Los Angeles, California, United States (enrolling)
• Florida Lung Asthma and Sleep Specialist — Celebration, Florida, United States (enrolling)
• Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando — Orlando, Florida, United States (enrolling)
• Southeastern Research Center — Winston-Salem, North Carolina, United States (enrolling)
• University of Oklahoma Health Sciences Center (OUHSC) — Oklahoma City, Oklahoma, United States (enrolling)
• Temple University Hospital-Temple Lung Center — Philadelphia, Pennsylvania, United States (enrolling)
• Bogan Sleep Consultants, LLC — Columbia, South Carolina, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Metroplex Pulmonary and Sleep Center — McKinney, Texas, United States (enrolling)
• Research Centers of America — McKinney, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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