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NCT05975983PHASE2Recruiting

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

InSilico Medicine Hong Kong Limited

Start Date

2/8/2024

Completion Date

2/28/2026

Summary

The purpose of this revised Phase IIa study is to demonstrate safety of INS018\_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).

Detailed Description

Idiopathic pulmonary fibrosis is a fatal lung disease characterized by reduced quality of life (QoL) and a median survival of 3 to 4 years. While current standard of care (SoC) treatments including pirfenidone and nintedanib slow disease progression, they are not curative and poorly tolerated due to their toxicity profiles. To address the need for new treatments in IPF, InSilico Medicine is developing INS018\_055, a potent inhibitor of the serine/threonine kinase Traf2- and Nckinteracting kinase (TNIK).

Eligibility Criteria

Age Range: 40 years to No maximum

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. Meeting all of the following criteria during the screening period: 1. FVC ≥40% predicted normal 2. DLCO corrected for Hgb ≥25% and \<80% predicted 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

Interventions

DRUG

INS018_055

DRUG

Placebo

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Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

HonorHealth Research Institute

Scottsdale, Arizona 85258

United States

Keck School of Medicine of USC

Los Angeles, California 90033

United States

Florida Lung Asthma and Sleep Specialist

Celebration, Florida 34747-1818

United States

Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando

Orlando, Florida 32803-5727

United States

Southeastern Research Center

Winston-Salem, North Carolina 27103-4007

United States

University of Oklahoma Health Sciences Center (OUHSC)

Oklahoma City, Oklahoma 73104-5417

United States

Temple University Hospital-Temple Lung Center

Philadelphia, Pennsylvania 19140

United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina 29201-2953

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75235-6243

United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas 75069-1898

United States

Research Centers of America

McKinney, Texas 75071

United States