Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
- Conditions
- Interventions
- Registration Number
- NCT05975983
- Lead Sponsor
- InSilico Medicine Hong Kong Limited
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Group 4: Placebo once or twice daily up to 12 weeks INS018_055 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
- Primary Outcome Measures
Name Time Method Percentage of patients who have at least 1 treatment-emergent adverse event (TEAE) Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and metabolites (INS018_063 and INS018_095) Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT)) Number of acute IPF exacerbations Week 0 up to Week 12 Terminal elimination half-life (t1/2) of INS018_055 and metabolites (INS018_063 and INS018_095) Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT)) Maximum plasma concentration (Cmax) of INS018_055 and metabolites (INS018_063 and INS018_095) Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT)) Time at which the maximum plasma concentration occurred (tmax) of INS018_055 and metabolites (INS018_063 and INS018_095) Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT)) Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of INS018_055 and metabolites (INS018_063 and INS018_095) Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT)) Apparent clearance (CL/F) of INS018_055 and metabolites (INS018_063 and INS018_095) Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT)) Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and metabolites (INS018_063 and INS018_095) Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT)) Trough plasma concentration (Ctrough) of INS018_055 and metabolites (INS018_063 and INS018_095) Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT)) Percentage change in FVC in mL Week 0/Visit 2 up to Week 12 Area under the plasma concentration-time curve from time zero to dosing interval τ (AUC0-τ) of INS018_055 and metabolites (INS018_063 and INS018_095) Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT)) Terminal elimination rate constant (λz) of INS018_055 and metabolites (INS018_063 and INS018_095) Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT)) Relative change in Forced Vital Capacity (FVC) in mL Week 0/Visit 2 up to Week 12 Change in 6-Minute Walk Distance (6MWD) in meters Week 0 to Week 12 Apparent volume of distribution (Vz/F) of INS018_055 and metabolites (INS018_063 and INS018_095) Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT)) Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted Week 0/Visit 2 to Week 12 Change in Leicester Cough Questionnaire (LCQ) Week 0 to Week 4, 8 and 12 Number of days hospitalized for acute IPF exacerbations Week 0 to up Week 12 Absolute and relative change in FVC % predicted Week 0/Visit 2 up to Week 12
Trial Locations
- Locations (9)
Bogan Sleep Consultants, LLC
🇺🇸Columbia, South Carolina, United States
Keck School of Medicine of USC
🇺🇸Los Angeles, California, United States
University of Oklahoma Health Sciences Center (OUHSC)
🇺🇸Oklahoma City, Oklahoma, United States
Florida Lung Asthma and Sleep Specialist
🇺🇸Celebration, Florida, United States
Southeastern Research Center
🇺🇸Winston-Salem, North Carolina, United States
Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
🇺🇸Orlando, Florida, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Research Centers of America
🇺🇸McKinney, Texas, United States
Metroplex Pulmonary and Sleep Center
🇺🇸McKinney, Texas, United States