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Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Primary Purpose

Idiopathic Pulmonary Fibrosis (IPF)

Status

Not yet recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

INS018_055

Placebo

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis (IPF) focused on measuring Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Fibrosis, Pathologic Processes, Lung Diseases, Interstitial, Lung Diseases, Respiratory Tract Diseases

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 6 months prior to screening and until the end of the study Female patients who are pregnant or nursing Abnormal ECG findings

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

INS018_055

Placebo

Arm Description

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

Group 4: Placebo once or twice daily up to 12 weeks

Outcomes

Primary Outcome Measures

Percentage of patients who have at least 1 treatment-emergent adverse event (TEAE)

Secondary Outcome Measures

Maximum plasma concentration (Cmax) of INS018_055 and metabolites (INS018_063 and INS018_095)

Time at which the maximum plasma concentration occurred (tmax) of INS018_055 and metabolites (INS018_063 and INS018_095)

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)

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)

Area under the plasma concentration-time curve from time zero to infinity (∞) (AUC0-∞) of INS018_055 and metabolites (INS018_063 and INS018_095)

Terminal elimination half-life (t1/2) of INS018_055 and metabolites (INS018_063 and INS018_095)

Terminal elimination rate constant (λz) of INS018_055 and metabolites (INS018_063 and INS018_095)

Apparent clearance (CL/F) of INS018_055 and metabolites (INS018_063 and INS018_095)

Apparent volume of distribution (Vz/F) of INS018_055 and metabolites (INS018_063 and INS018_095)

Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and metabolites (INS018_063 and INS018_095)

Trough plasma concentration (Ctrough) of INS018_055 and metabolites (INS018_063 and INS018_095)

Relative change in Forced Vital Capacity (FVC) in mL

Percentage change in FVC in mL

Absolute and relative change in FVC % predicted

Change in Diffusion Capacity of the lung for Carbon Monoxide (DLCO) % predicted

Change in Leicester Cough Questionnaire (LCQ)

Change in 6-Minute Walk Distance (6MWD) in meters

Number of acute IPF exacerbations

Number of days hospitalized for acute IPF exacerbations

Full Information

NCT ID

NCT05975983

First Posted

July 27, 2023

Last Updated

August 21, 2023

Sponsor

InSilico Medicine Hong Kong Limited

1. Study Identification

Unique Protocol Identification Number

NCT05975983

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2023 (Anticipated)

Primary Completion Date

February 28, 2026 (Anticipated)

Study Completion Date

February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InSilico Medicine Hong Kong Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Pulmonary Fibrosis (IPF)

Keywords

Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Fibrosis, Pathologic Processes, Lung Diseases, Interstitial, Lung Diseases, Respiratory Tract Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

INS018_055

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Group 4: Placebo once or twice daily up to 12 weeks

Intervention Type

Drug

Intervention Name(s)

INS018_055

Intervention Description

Pharmaceutical formulation: Capsules Mode of Administration: Oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pharmaceutical formulation: Capsules Mode of Administration: Oral

Primary Outcome Measure Information:

Title

Percentage of patients who have at least 1 treatment-emergent adverse event (TEAE)

Time Frame

Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))

Secondary Outcome Measure Information:

Title

Maximum plasma concentration (Cmax) of INS018_055 and metabolites (INS018_063 and INS018_095)

Time Frame