Deupirfenidone for Pulmonary Fibrosis

(SURPASS-IPF Trial)

This trial examines a new treatment called deupirfenidone for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that causes breathing difficulties. The researchers aim to determine if deupirfenidone can improve lung function and ensure safety compared to the existing drug, pirfenidone. Participants will be randomly assigned to receive either deupirfenidone or pirfenidone without knowing which one they are taking. This trial may suit those diagnosed with IPF within the last 7 years who have not previously taken pirfenidone. Participants will undergo regular check-ups and lung tests throughout the study, which lasts up to 3 years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

The trial requires that you stop taking any antifibrotic medications before participating. If you are on prednisone, you must be on a stable dose of 10 mg/day or less for at least 30 days before starting the trial.

Earlier studies have shown that deupirfenidone is generally safe and well tolerated for people with idiopathic pulmonary fibrosis (IPF). Research indicates that deupirfenidone has a good safety record and works well across different age groups. No major safety issues emerged, supporting its continued use for treating IPF.

Pirfenidone, the other treatment in this study, already has approval for IPF. It has proven safe and generally well tolerated over long-term use, with some patients taking it for up to 7.7 years. Common side effects, such as rash and stomach upset, are mild and rarely lead to discontinuation.

Deupirfenidone is unique because it offers a potentially improved approach for treating pulmonary fibrosis compared to existing therapies like pirfenidone. Unlike the standard treatment, which primarily focuses on slowing disease progression, deupirfenidone may offer enhanced efficacy due to its slightly different molecular structure. This small change could lead to better absorption and effectiveness, making it a promising option for patients who need more effective management of their condition. Researchers are excited about deupirfenidone because it represents a next-generation advancement in treatment that could improve quality of life for those affected by this challenging disease.

This trial will compare deupirfenidone and pirfenidone for treating idiopathic pulmonary fibrosis (IPF). Research has shown that deupirfenidone may slow the progression of lung disease over 26 weeks and help maintain lung function over 52 weeks. Specifically, it reduced the decline in lung function, with a 91 mL decrease in Forced Vital Capacity (FVC, a measure of lung health), and is well-tolerated across different age groups.