INS018_055: Pharmaceutical formulation: Tablet
Mode of Administration: Oral
Placebo: Pharmaceutical formulation: Tablet
Mode of Administration: Oral
Study 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).
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE) — Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))
Trial sites (12)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
Recruiting
HonorHealth Research Institute
Scottsdale
Arizona
Recruiting
Keck School of Medicine of USC
Los Angeles
California
Recruiting
Florida Lung Asthma and Sleep Specialist
Celebration
Florida
Recruiting
Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
Orlando
Florida
Recruiting
Southeastern Research Center
Winston-Salem
North Carolina
Recruiting
University of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City
Oklahoma
Recruiting
Temple University Hospital-Temple Lung Center
Philadelphia
Pennsylvania
Recruiting
Bogan Sleep Consultants, LLC
Columbia
South Carolina
Recruiting
University of Texas Southwestern Medical Center
Dallas
Texas
Recruiting
Metroplex Pulmonary and Sleep Center
McKinney
Texas
Recruiting
Research Centers of America
McKinney
Texas
Recruiting
More InSilico Medicine Hong Kong Limited trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.