PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

Launched by UNIVERSITY OF MASSACHUSETTS, WORCESTER · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a condition called Progressive Pulmonary Fibrosis (PPF), which is a form of lung disease that causes scarring and breathing difficulties. The goal of the study is to better understand how to classify PPF and to learn how often it occurs in different types of interstitial lung disease (ILD). Over a period of 24 months, researchers will follow participants who have a specific type of fibrotic ILD. They will collect information about the participants’ health, lung images, and biological samples to help improve the understanding and treatment of this condition.

To be eligible for the study, participants must be between 18 and 80 years old and have a diagnosis of non-idiopathic fibrotic ILD, which means their lung disease is due to certain known causes. They should also be willing to follow study procedures and provide consent to participate. Throughout the study, participants will undergo tests and assessments to monitor their condition, but they will not receive any new treatments as part of this observational study. It’s important to note that this trial is not yet recruiting participants, so there may be waiting time before enrollment begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-80 years with a diagnosis of non-IPF fibrosing ILD due to CTD-ILD, fHP, or non-IPF IIP based on central review
• • Diagnosis of Fibrotic ILD as determined by site investigator.
• • Willingness to comply with study procedures and follow-up.
• • Provide written informed consent.
• Exclusion Criteria:
• • Site diagnosis of fibrosing ILD \>5 years prior to Visit 1 (Screening and Baseline Visit).
• • Minimal ILD, defined as reticular opacities and/or ground-glass opacities without architectural distortion (traction bronchiolectasis/bronchiectasis or honeycombing) affecting \< 5% of the lung on centralized evaluation of HRCT at Visit 1 (Screening and Baseline Visit). High quality historical chest HRCT may be used if performed within 90 days prior to Visit 1.
• • Extent of emphysema \>15% of total lung volume or greater than extent of fibrosis based on central, qualitative assessment of HRCT at Visit 1. High quality historical chest HRCT may be used if performed within 90 days prior to Visit 1.
• • Active malignancy within one year prior to Visit 1 (except for non-melanoma skin cancer requiring local treatment).
• • Inability to complete full PFT (spirometry and DLCO) at Visit 1. Historical PFT may be used if performed within 90 days prior to Visit 1.
• • Taking nintedanib or nerandomilast at Visit 1.
• • Pregnancy at screening or plans to become pregnant during follow-up.
• • Participation in an interventional clinical trial for fibrotic ILD at the time of Visit 1, or receipt of an investigational drug within the previous 4 weeks of the enrollment visit (Visit 1) or 5 times the half-life, if longer.