Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Launched by INSILICO MEDICINE HONG KONG LIMITED · Jul 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called INS018_055 for adults with a condition known as Idiopathic Pulmonary Fibrosis (IPF), which affects the lungs and makes it hard to breathe. The main goal is to see how safe this treatment is and how well people can tolerate it when taken by mouth for up to 12 weeks. Some participants will receive the actual medication, while others will receive a placebo, which is like a sugar pill with no active ingredients.

To be eligible for this study, participants need to be at least 40 years old and have a confirmed diagnosis of IPF. They should also be in stable health, meaning their condition hasn't worsened recently. People who are currently taking certain medications for IPF may also be included if their treatment has been stable for at least 8 weeks. During the trial, participants will undergo regular check-ups to monitor their health and response to the treatment. It's important to note that individuals with recent flare-ups of IPF, those who smoke, or women who are pregnant or nursing cannot participate in this study. If you're interested, this trial is currently recruiting participants.

Gender

ALL

Eligibility 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. Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for ≥ 8 weeks prior to Visit 1
• Meeting all of the following criteria during the screening period:
• • 1. FVC ≥40% predicted of normal
• • 2. DLCO corrected for Hgb ≥25% and \<80% predicted of 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