Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis (IPF) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05975983
• Other study ID #: INS018-055-004
• Status: Recruiting
• Phase: Phase 2
• Start date: February 8, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2024
• Source: InSilico Medicine Hong Kong Limited
• Contact: Yichen Liu
• Phone: +86 18817554306
• Email: Insilico-Clinicaltrial[@]insilico.ai
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

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. 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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Idiopathic Pulmonary Fibrosis (IPF)
• Pulmonary Fibrosis

Intervention

Drug:
• INS018_055
Pharmaceutical formulation: Capsules Mode of Administration: Oral
• Placebo
Pharmaceutical formulation: Capsules Mode of Administration: Oral

Locations

Country	Name	City	State
United States	Florida Lung Asthma and Sleep Specialist	Celebration	Florida
United States	Bogan Sleep Consultants, LLC	Columbia	South Carolina
United States	Univerity of Texas Southwestern Medical Center	Dallas	Texas
United States	Keck School of Medicine of USC	Los Angeles	California
United States	Metroplex Pulmonary and Sleep Center	McKinney	Texas
United States	Research Centers of America	McKinney	Texas
United States	University of Oklahoma Health Sciences Center (OUHSC)	Oklahoma City	Oklahoma
United States	Southeastern Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
InSilico Medicine Hong Kong Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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))
Secondary	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))
Secondary	Area under the plasma concentration-time curve from time zero to dosing interval 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))
Secondary	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))
Secondary	Area under the plasma concentration-time curve from time zero to infinity (8) (AUC0-8) 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))
Secondary	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))
Secondary	Terminal elimination rate constant (?z) 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))
Secondary	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))
Secondary	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))
Secondary	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))
Secondary	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))
Secondary	Relative change in Forced Vital Capacity (FVC) in mL		Week 0/Visit 2 up to Week 12
Secondary	Percentage change in FVC in mL		Week 0/Visit 2 up to Week 12
Secondary	Absolute and relative change in FVC % predicted		Week 0/Visit 2 up to Week 12
Secondary	Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted		Week 0/Visit 2 to Week 12
Secondary	Change in Leicester Cough Questionnaire (LCQ)		Week 0 to Week 4, 8 and 12
Secondary	Change in 6-Minute Walk Distance (6MWD) in meters		Week 0 to Week 12
Secondary	Number of acute IPF exacerbations		Week 0 up to Week 12
Secondary	Number of days hospitalized for acute IPF exacerbations		Week 0 to up Week 12