Clinical Trails Post

February 2025 clinical trial highlights

by Pulmonary Fibrosis Foundation
February 24, 2025

In the February 2025 clinical trial highlights, we'll showcase just a few of the many trials that are open for enrollment and seeking volunteers. To view more available trials for various forms of interstitial lung disease (ILD), please visit the 🔍 PFF Clinical Trial Finder.



Seeking participants with progressive pulmonary fibrosis

TETON-PPF

  • Study ID: NCT05943535
  • Trial Phase: Phase 3
  • Intervention: Inhaled drug
  • Sponsor: United Therapeutics
  • Study Contact: 919.485.8350, clinicaltrials@unither.com

Learn more about this study

Learn more about this drug

 


Seeking participants with pulmonary hypertension associated with interstitial lung disease

DeciPHer-ILD

  • Study ID: NCT06388421
  • Intervention: Observational
  • Sponsor: United Therapeutics
  • Study Contact: 919.485.8350, clinicaltrials@unither.com

Learn more about this study

 


Seeking participants with idiopathic pulmonary fibrosis

ASPIRE

  • Study ID: NCT06588686
  • Trial Phase: Phase 2
  • Intervention: Oral drug
  • Sponsor: Vicore Pharma AB
  • Study Contact: Thomas Eskildsen (+ 46 317880560, info@aspire-ipf.com); Cecilia Ganslandt (+ 46 317880560, info@aspire-ipf.com)

Learn more about this study

Learn more about this drug


Research spotlight

2024 PFF Education Symposium available on YouTube

To learn more about the three clinical trials featured in this newsletter, watch the Clinical Trial Innovation Series session hosted on Friday, November 8, 2024, during the 2024 PFF Education Symposium. You will hear directly from the industry representatives running these research studies.

The purpose of the Clinical Trial Innovation Series is to provide up-to-date information about the development of innovative therapies and advancements in research to improve the lives of those living with pulmonary fibrosis (PF) and ILD.

Collaboration is key, the PFF attends the Lung Transplant Patient Advocacy Roundtable

Recently, the PFF was honored to meet with other patient advocacy groups at the Lung Transplant Patient Advocacy Roundtable, where we discussed how we can work together to build greater access to organ transplants for those with ILD. Among the agenda items were the latest information about the Ex Vivo Lung Perfusion and other advancements in lung transplant. 

A big thank you to Jennifer Mefford (VP of Corporate Partnerships) and Dr. Wayne Pan (Chair, Board of Directors) who attended to represent the PF community, as well as to United Therapeutics for hosting everyone.

The FDA grants buloxibutid Fast Track designation for idiopathic pulmonary fibrosis

In January 2025, Vicore Pharma announced the United States Food and Drug Administration (FDA) has granted Fast Track designation to buloxibutid. This designation is designed to advance the development and review of drugs which treat serious conditions to fill unmet medical needs. The purpose is to get important new drugs to patients earlier.

Vicore Pharma is assessing the orally administered drug, buloxibutid, to determine its efficacy, safety, and pharmacokinetics — the study of how the body interacts with the treatment for the entire duration of exposure — in participants with IPF. You can learn more about this designation and Vicore’s clinical trial here.

Phase 3 progressive pulmonary fibrosis study meets its primary endpoint

ILDs are a large category of diseases that have either fibrosis, inflammation, or both, in the walls of the air sacs in the lungs. There are over 200 specific diagnoses that are categorized as ILDs. Fibrosis, or tissue scarring, can be present in many types of ILDs, and when the fibrosis worsens over time, this is referred to as “progressive pulmonary fibrosis” (PPF) and may also be termed “progressive fibrotic ILD” (PF-ILD).

In February 2025, Boehringer Ingelheim announced that the phase 3 clinical trial, FIBRONEER™-ILD, met its primary endpoint.

A primary endpoint is the measurement that researchers use to determine if a medication or other intervention works as intended. In this study, forced vital capacity (FVC) was the primary endpoint. FVC is the measurement obtained when a patient completes a spirometry test (e.g., pulmonary function test).

The FIBRONEER™-ILD trial is part of the FIBRONEER™ global program, which also includes the Phase 3 IPF study, FIBRONEER™-IPF. In September 2024, Boehringer Ingelheim announced that FIBRONEER™-IPF met its primary endpoint. These trials achieving their endpoint mark a significant development in advancing care for patients living with ILD and demonstrates the importance of research studies which support the development of improved therapies.

To learn more about clinical trials, review the PFF’s clinical trial guide and the PFF’s pulmonary function tests guide. To learn more about PPF and PF-ILD, review the progressive pulmonary fibrosis and progressive fibrotic interstitial lung disease fact sheet.