Recruiting

Observational Study

Sponsor:

University of Massachusetts, Worcester

Code:

NCT06855329

Conditions

Progressive Pulmonary Fibrosis

Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a prospective, observational cohort study. Participants with non-idiopatic pulmonary fibrosis, interstitial lung disease (ILD) will be followed for 24 months to systematically collect clinical, imaging, and biospecimen data. The primary objective is to optimize progressive pulmonary fibrosis (PPF) classification and establish PPF incidence for key ILD subtypes. Additional exploratory objectives are to 1) Prospectively validate a novel PPF classifier and assess performance durability over time, and 2) Determine whether multi-dimensional PPF prediction outperforms component approaches.

Conditions

Progressive Pulmonary Fibrosis

Interstitial Lung Disease

Study ID

NCT06855329

Start date

May 1, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Transplant-free survival (TFS) [ Time Frame: 12-months to 24-months (following an observation period from 0 months to 12 months) ]

Central Contacts and Locations

Central contacts

Fernando J Martinez, MD, MS

508-334-8685fernando.martinez1@umassmed.edu

Elizabeth Peters, BSN

774-455-4432elizabeth.peters2@umassmed.edu

Locations

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Roberto Caricchio, MD

lupus.caricchio@umassmed.edu

Betsy Peters, BSN

774-455-4432elizabeth.peters2@umassmed.edu

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Janelle Pugashetti, MD

vupugash@med.umich.edu

Nisha Mohan

vupugash@med.umich.edu

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Chad Newton, MD

214-645-6493Chad.Newton@UTSouthwestern.edu

Nighat Sultana, MBBS

214-645-6605nighat.sultana@utsouthwestern.edu

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Tessy Paul, MD

434-243-2398TKP4N@hscmail.mcc.virginia.edu

Yousef Althulth

kpq5sk@uvahealth.org

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Ganesh Raghu, MD

(206) 598-4967graghu@uw.edu

Katherine Palaeologus

(206)843-0228kpal444@uw.edu

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Chris Ryerson, MD

1(604)258-8682Chris.Ryerson@hli.ubc.ca

Miriam Margari

1(236)808-0804miriam.margari@hli.ubc.ca

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Progressive pulmonary fibrosis
  • Interstitial lung disease
  • PRIME
  • PRIME-PPF
  • PPF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-08-18.