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Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

NCT ID: NCT05975983

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-08

Study Completion Date

2026-02-28

Brief Summary

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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

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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).

Conditions

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Idiopathic Pulmonary Fibrosis (IPF)

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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INS018_055

INS018\_055 is administered once daily up to 12 weeks

Group Type EXPERIMENTAL

INS018_055

Intervention Type DRUG

Pharmaceutical formulation: Tablet

Mode of Administration: Oral

Placebo

Placebo is administered once daily up to 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pharmaceutical formulation: Tablet

Mode of Administration: Oral

Interventions

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INS018_055

Pharmaceutical formulation: Tablet

Mode of Administration: Oral

Intervention Type DRUG

Placebo

Pharmaceutical formulation: Tablet

Mode of Administration: Oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InSilico Medicine Hong Kong Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

HonorHealth Research Institute

Scottsdale, Arizona, United States

Site Status RECRUITING

Keck School of Medicine of USC

Los Angeles, California, United States

Site Status RECRUITING

Florida Lung Asthma and Sleep Specialist

Celebration, Florida, United States

Site Status RECRUITING

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

Orlando, Florida, United States

Site Status RECRUITING

Southeastern Research Center

Winston-Salem, North Carolina, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center (OUHSC)

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Temple University Hospital-Temple Lung Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Bogan Sleep Consultants, LLC

Columbia, South Carolina, United States

Site Status RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Metroplex Pulmonary and Sleep Center

McKinney, Texas, United States

Site Status RECRUITING

Research Centers of America

McKinney, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Monique Duncan

Role: CONTACT

Phone: +86 18817554306

Email: [email protected]

Carol Salter, MD, PhD

Role: CONTACT

Email: [email protected]

Other Identifiers

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INS018-055-004

Identifier Type: -

Identifier Source: org_study_id