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NCT05975983RecruitingPhase 2

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

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)

Source: ClinicalTrials.gov · Last updated 12 Nov 2025

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
27 Jul 2023
Start date
8 Feb 2024
Primary completion date
28 Feb 2026
Lead sponsor
InSilico Medicine Hong Kong Limited
NCT number
NCT05975983

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 40
  • From 8 Feb 2024 to the primary completion date, 28 Feb 2026
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 3 months prior to screening and until the end of the study

Other

  • Female patients who are pregnant or nursing
  • Abnormal ECG findings

Who the study is looking for

  • 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
  • Meeting all of the following criteria during the screening period:
    • FVC ≥40% predicted normal
    • DLCO corrected for Hgb ≥25% and \<80% predicted normal
    • Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio \>0.7 based on pre-bronchodilator value

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
Florida Lung Asthma and Sleep Specialist
Coordinator of this site? Confirm its status
CelebrationUnited StatesRecruiting
Bogan Sleep Consultants, LLC
Coordinator of this site? Confirm its status
ColumbiaUnited StatesRecruiting
University of Texas Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Keck School of Medicine of USC
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Research Centers of America
Coordinator of this site? Confirm its status
McKinneyUnited StatesRecruiting
Metroplex Pulmonary and Sleep Center
Coordinator of this site? Confirm its status
McKinneyUnited StatesRecruiting
University of Oklahoma Health Sciences Center (OUHSC)
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesRecruiting
Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
Temple University Hospital-Temple Lung Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
HonorHealth Research Institute
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesRecruiting
Southeastern Research Center
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.