Celea Therapeutics Doses First Patient in Global Phase 3 SURPASS-IPF Trial for Idiopathic Pulmonary Fibrosis
Monday, July 13, 2026
Celea Therapeutics has dosed the first patient in the global Phase 3 SURPASS-IPF trial evaluating deupirfenidone as a treatment for idiopathic pulmonary fibrosis (IPF). The study will compare deupirfenidone 825 mg taken three times daily with pirfenidone 801 mg taken three times daily to assess whether the investigational treatment offers improved efficacy.
The Phase 3 trial follows the company's recent $180 million financing, which is supporting the continued development of deupirfenidone as a potential treatment option for people with IPF.
SURPASS-IPF is a global, randomised, double-blind, head-to-head study involving approximately 1,100 adults with IPF who are not receiving background antifibrotic therapy. The trial will run for 52 weeks across more than 30 countries. Its primary endpoint is the change from baseline in absolute forced vital capacity (FVC), while secondary assessments will further evaluate the safety and tolerability of deupirfenidone.
The trial is designed without a placebo group. Instead, all participants will receive active treatment, with deupirfenidone compared directly against the approved antifibrotic therapy pirfenidone. This approach aims to provide meaningful clinical data while ensuring every participant receives an established or investigational treatment.
SURPASS-IPF builds on results from the Phase 2b ELEVATE-IPF trial and its open-label extension, which indicated that deupirfenidone could slow lung function decline while maintaining a favourable safety and tolerability profile. The Phase 3 study uses the same dosing regimen and active comparator as the earlier trial to provide continuity across the clinical development programme.
Topline results from the SURPASS-IPF trial are expected in the second half of 2029. Based on feedback from the US Food and Drug Administration (FDA), findings from this single Phase 3 study, together with data from the broader deupirfenidone development programme, could support a future regulatory submission in the United States.
SURPASS-IPF (NCT07284602) is evaluating the superiority of deupirfenidone 825 mg taken three times daily over pirfenidone 801 mg taken three times daily in adults with idiopathic pulmonary fibrosis who are not receiving background antifibrotic therapy. The study plans to enrol around 1,100 participants worldwide.
Source: businesswire.com
