Clinical Trials in the USA / NCT05975983
Recruiting
Phase 2
Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
NCT05975983 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Idiopathic Pulmonary Fibrosis (IPF)
Investigational drug(s) / intervention(s)
INS018_055 →Placebo
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
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 |
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Official registry record
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.
View NCT05975983 on ClinicalTrials.gov ↗ ← All trials in the USA