Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
Purpose
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.
Condition
- Idiopathic Pulmonary Fibrosis (IPF)
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Florida Lung Asthma and Sleep Specialist
Celebration, Florida 34747-1818
Celebration, Florida 34747-1818
Southeastern Research Center
Winston-Salem, North Carolina 27103-4007
Winston-Salem, North Carolina 27103-4007
Bogan Sleep Consultants, LLC
Columbia, South Carolina 29201-2953
Columbia, South Carolina 29201-2953
Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069-1898
McKinney, Texas 75069-1898
More Details
- NCT ID
- NCT05975983
- Status
- Recruiting
- Sponsor
- InSilico Medicine Hong Kong Limited