A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The goal of this clinical trial is to learn about INS018\_055 in adults with Idiopathic Pulmonary Fibrosis (IPF). The primary objective is to evaluate the safety and tolerability of INS018\_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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
• 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:
• FVC ≥40% predicted of normal
• DLCO corrected for Hgb ≥25% and \<80% predicted of normal.
• forced expiratory volume in the first second/FVC (FEV1/FVC) ratio \>0.7 based on pre-bronchodilator value
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
HonorHealth Research Institute
RECRUITING
Scottsdale
California
Keck School of Medicine of USC
RECRUITING
Los Angeles
Florida
Florida Lung Asthma and Sleep Specialist
RECRUITING
Celebration
Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
RECRUITING
Orlando
North Carolina
Southeastern Research Center
RECRUITING
Winston-salem
Oklahoma
University of Oklahoma Health Sciences Center (OUHSC)
RECRUITING
Oklahoma City
Pennsylvania
Temple University Hospital-Temple Lung Center
RECRUITING
Philadelphia
South Carolina
Bogan Sleep Consultants, LLC
RECRUITING
Columbia
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Metroplex Pulmonary and Sleep Center
RECRUITING
Mckinney
Research Centers of America
RECRUITING
Mckinney
Contact Information
Primary
Monique Duncan
Insilico-Clinicaltrial@insilico.ai
+86 18817554306
Backup
Carol Salter, MD, PhD
Insilico-Clinicaltrial@insilico.ai
Time Frame
Start Date:2024-02-08
Estimated Completion Date:2026-02-28
Participants
Target number of participants:60
Treatments
Experimental: INS018_055
Group 1: INS018\_055 once daily up to 12 weeks, low dose~Group 2: INS018\_055 twice daily up to 12 weeks, low dose~Group 3: INS018\_055 once daily up to 12 weeks, high dose
Placebo_comparator: Placebo
Group 4: Placebo once or twice daily up to 12 weeks