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
- Diseases
- Idiopathic pulmonary fibrosis
- 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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Florida Lung Asthma and Sleep Specialist Coordinator of this site? Confirm its status | Celebration | United States | Recruiting |
| Bogan Sleep Consultants, LLC Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Keck School of Medicine of USC Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Research Centers of America Coordinator of this site? Confirm its status | McKinney | United States | Recruiting |
| Metroplex Pulmonary and Sleep Center Coordinator of this site? Confirm its status | McKinney | United States | Recruiting |
| University of Oklahoma Health Sciences Center (OUHSC) Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Temple University Hospital-Temple Lung Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| HonorHealth Research Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Southeastern Research Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.