About this trial
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).
Eligibility criteria
Qualifiers
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
FVC ≥40% predicted normal
Disqualifiers
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
Trial design
Treatments tested in this trial
- INS018_055
- Placebo