RECRUITING

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Conditions

Idiopathic Pulmonary Fibrosis (IPF)Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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)

Quick Facts

Study Start:2024-02-08

Study Completion:2026-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05975983

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Monique Duncan

CONTACT

+86 18817554306

Insilico-Clinicaltrial@insilico.ai

Carol Salter, MD, PhD

CONTACT

Insilico-Clinicaltrial@insilico.ai

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: InSilico Medicine Hong Kong Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-08

Study Completion Date2026-02-28

Study Record Updates

Study Start Date2024-02-08

Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Idiopathic Pulmonary Fibrosis (IPF)