Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Last updated: November 10, 2025
Sponsor: InSilico Medicine Hong Kong Limited
Overall Status: Active - Recruiting

Phase

2

Condition

Lung Disease

Cystic Fibrosis

Lung Injury

Treatment

Placebo

INS018_055

Clinical Study ID

NCT05975983
INS018-055-004
  • Ages > 40
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female patients aged ≥40 years based on the date of the written informedconsent form

  2. Diagnosis of IPF as defined by American Thoracic Society/European RespiratorySociety/Japanese Respiratory Society/Latin American Thoracic Association guidelines

  3. In a stable condition and suitable for study participation based on the results ofmedical history, physical examination, vital signs, 12-lead ECG, and laboratoryevaluation

  4. Meeting all of the following criteria during the screening period:

  5. FVC ≥40% predicted normal

  6. DLCO corrected for Hgb ≥25% and <80% predicted normal

  7. Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio >0.7 based onpre-bronchodilator value

Exclusion

Exclusion Criteria:

  1. Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determinedby the investigator

  2. Patients who are unwilling to refrain from smoking within 3 months prior toscreening and until the end of the study

  3. Female patients who are pregnant or nursing

  4. Abnormal ECG findings

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 08, 2024
Estimated Completion Date:
February 28, 2026

Study 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).

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35294
    United States

    Active - Recruiting

  • HonorHealth Research Institute

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • HonorHealth Research Institute

    Scottsdale 5313457, Arizona 5551752 85258
    United States

    Active - Recruiting

  • Keck School of Medicine of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • Keck School of Medicine of USC

    Los Angeles 5368361, California 5332921 90033
    United States

    Active - Recruiting

  • Florida Lung Asthma and Sleep Specialist

    Celebration, Florida 34747-1818
    United States

    Site Not Available

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

    Orlando, Florida 32803-5727
    United States

    Site Not Available

  • Florida Lung Asthma and Sleep Specialist

    Celebration 4150394, Florida 4155751 34747-1818
    United States

    Active - Recruiting

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

    Orlando 4167147, Florida 4155751 32803-5727
    United States

    Active - Recruiting

  • Southeastern Research Center

    Winston-Salem, North Carolina 27103-4007
    United States

    Site Not Available

  • Southeastern Research Center

    Winston-Salem 4499612, North Carolina 4482348 27103-4007
    United States

    Active - Recruiting

  • University of Oklahoma Health Sciences Center (OUHSC)

    Oklahoma City, Oklahoma 73104-5417
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center (OUHSC)

    Oklahoma City 4544349, Oklahoma 4544379 73104-5417
    United States

    Active - Recruiting

  • Temple University Hospital-Temple Lung Center

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Temple University Hospital-Temple Lung Center

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Active - Recruiting

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina 29201-2953
    United States

    Site Not Available

  • Bogan Sleep Consultants, LLC

    Columbia 4575352, South Carolina 4597040 29201-2953
    United States

    Active - Recruiting

  • Univerity of Texas Southwestern Medical Center

    Dallas, Texas 75235-6243
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75235-6243
    United States

    Site Not Available

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas 75069-1898
    United States

    Site Not Available

  • Research Centers of America

    McKinney, Texas 75071
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75235-6243
    United States

    Active - Recruiting

  • Metroplex Pulmonary and Sleep Center

    McKinney 4710178, Texas 4736286 75069-1898
    United States

    Active - Recruiting

  • Research Centers of America

    McKinney 4710178, Texas 4736286 75071
    United States

    Active - Recruiting

  • University of Utah, University Hospital

    Salt Lake City, Utah 84132
    United States

    Site Not Available

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