ASCEND is a multinational, randomized, double-blind, placebo controlled Phase 3 trial designed to evaluate the safety and efficacy of Esbriet® (pirfenidone) in IPF patients with mild to moderate impairment in lung function. The primary endpoint is lung function, as measured by change in forced vital capacity (FVC) from baseline to Week 52. The trial will enroll a total of approximately 500 patients
who are randomly assigned 1:1 to receive oral pirfenidone (2403 mg/day) or placebo.
The primary endpoint in the ASCEND study is change in percent predicted FVC, with the primary outcome analysis a Rank ANCOVA at Week 52. The magnitude of effect will be presented on a categorical basis as the proportion of patients with decrements of less than 0% or greater than 10% at pre-specified study time points.
Patient eligibility criteria for ASCEND include the following:
- Centrally confirmed diagnosis by High Resolution Computed Tomography (HRCT) (+/- surgical lung biopsy)
- %FVC 50% - 90%
- %DLco 30% - 90%
- FEV1/FVC ratio greater than 0.80
- Time since IPF diagnosis greater than six months and less than four years
Key secondary endpoints include change in six-minute walk test (6MWT) distance and progression-free survival, which will be based on the earliest of time to death, FVC decrement of 10% or greater, or decrement in 6MWT distance of 50 meters or more.
Other secondary endpoints include all-cause mortality, evaluated both independently as well as pooled with the previous CAPACITY data, and on-treatment IPF-related deaths, which also will be evaluated independently and pooled with the CAPACITY data, and dyspnea.
About Esbriet® (pirfenidone)
Esbriet is an orally active drug that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.