Depemokimab Phase 3 Trial for Severe Eosinophilic Asthma Completes Primary Study

The Phase 3 clinical trial for Depemokimab (also known as GSK3511294 or Exdensur) in participants with severe asthma with an eosinophilic phenotype completed its primary study on 2025-09-14. This study, which enrolled 1719 participants, aims to evaluate the non-inferiority of switching to Depemokimab compared to maintaining existing biologic treatments.

Background

Depemokimab is being investigated as a potential treatment for severe asthma with an eosinophilic phenotype. This condition is characterized by elevated levels of eosinophils, a type of white blood cell, which contribute to airway inflammation and asthma exacerbations. Current treatments often include biologics targeting specific inflammatory pathways.

Trial design

The study, identified as NCT04718389, is a Phase 3, randomized trial that enrolled 1719 participants diagnosed with severe asthma with an eosinophilic phenotype. The trial's primary objective is to assess whether switching participants who have already benefited from mepolizumab or benralizumab to Depemokimab is non-inferior to continuing their current biologic treatment. The primary endpoint focuses on the annualized rate of clinically significant asthma exacerbations. Throughout the study, all participants continue their non-biologic baseline standard of care (SoC) asthma treatment. Interventions included GSK3511294 (Depemokimab), mepolizumab, benralizumab, and placebo, alongside standard of care (SoC).

What this means

The primary completion of this Phase 3 trial for Depemokimab signifies that the main data collection period for the study's primary endpoint has concluded. Researchers will now proceed with the analysis of the collected data to determine if Depemokimab is non-inferior to established biologic treatments for severe eosinophilic asthma. The results of this study are anticipated to provide crucial insights into the potential role of Depemokimab as an alternative or switch-therapy option for patients whose severe asthma is managed with existing biologics.

Source

The information regarding the primary completion of this clinical trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The study record for NCT04718389, titled "A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype," was updated on 2025-09-14 on clinicaltrials.gov.