Clinical trial NCT05975983: Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Keywords: Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lead sponsor: InSilico Medicine Hong Kong Limited
Sponsor class: INDUSTRY
First posted: 2023-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients who have at least 1 treatment-emergent adverse event (TEAE)
timeFrame: Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) of INS018_055 and metabolites (INS018_063 and INS018_095)
timeFrame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
measure: Time at which the maximum plasma concentration occurred (tmax) of INS018_055 and metabolites (INS018_063 and INS018_095)
timeFrame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
measure: 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)
timeFrame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
measure: 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)
timeFrame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
measure: Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and metabolites (INS018_063 and INS018_095)
timeFrame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
measure: Terminal elimination half-life (t1/2) of INS018_055 and metabolites (INS018_063 and INS018_095)
timeFrame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
measure: Terminal elimination rate constant (λz) of INS018_055 and metabolites (INS018_063 and INS018_095)
timeFrame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
measure: Apparent clearance (CL/F) of INS018_055 and metabolites (INS018_063 and INS018_095)
timeFrame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
measure: Apparent volume of distribution (Vz/F) of INS018_055 and metabolites (INS018_063 and INS018_095)
timeFrame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
measure: Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and metabolites (INS018_063 and INS018_095)
timeFrame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
measure: Trough plasma concentration (Ctrough) of INS018_055 and metabolites (INS018_063 and INS018_095)
timeFrame: Following the first dose on Day 1 (Visit 2) and the last dose during Week 12 (Visit 6, End of Treatment (EOT))
measure: Relative change in Forced Vital Capacity (FVC) in mL
timeFrame: Week 0/Visit 2 up to Week 12
measure: Percentage change in FVC in mL
timeFrame: Week 0/Visit 2 up to Week 12
measure: Absolute and relative change in FVC % predicted
timeFrame: Week 0/Visit 2 up to Week 12
measure: Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted
timeFrame: Week 0/Visit 2 to Week 12
measure: Change in Leicester Cough Questionnaire (LCQ)
timeFrame: Week 0 to Week 4, 8 and 12
measure: Change in 6-Minute Walk Distance (6MWD) in meters
timeFrame: Week 0 to Week 12
measure: Number of acute IPF exacerbations
timeFrame: Week 0 up to Week 12
measure: Number of days hospitalized for acute IPF exacerbations
timeFrame: Week 0 to up Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
city: Celebration
country: United States
facility: Florida Lung Asthma and Sleep Specialist
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
state: Florida
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center (OUHSC)
state: Oklahoma
city: Columbia
country: United States
facility: Bogan Sleep Consultants, LLC
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center
state: Texas
city: McKinney
country: United States
facility: Research Centers of America
state: Texas
Study officials:
References: