Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Phase 2

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Interventions: Drug: Placebo; Drug: INS018_055

• 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

Study Timeline

• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-07-27
• Study First Posted: 2023-08-04
• Study Start: 2024-02-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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. 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

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

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