Trial results for depemokimab (GSK3511294) in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) were posted on ClinicalTrials.gov on 2025-12-03. The Phase 3 study, NCT05274750, showed that participants treated with depemokimab experienced a -0.7 difference in least squares mean change from baseline in total endoscopic nasal polyps score compared to placebo (95% CI: -1.1 to -0.3, p-value: 0.001).
Background
The study evaluated depemokimab in participants diagnosed with Chronic rhinosinusitis with nasal polyps (CRSwNP). This condition was the focus of the trial to assess the drug's efficacy and safety.
Trial design
The Phase 3 study, NCT05274750, was titled "Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps". It enrolled 276 participants diagnosed with Nasal Polyps. The trial compared treatment with depemokimab against placebo to evaluate efficacy and safety in this population.
Key results
The trial evaluated several outcomes at Week 52. Key findings include:
- For the "Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read)":
- The depemokimab group showed a least squares mean change of -0.6 (Standard Error: 0.14).
- The placebo group showed a least squares mean change of 0.2 (Standard Error: 0.15).
- The difference in least squares means was -0.7 (95.0% CI: -1.1 to -0.3), with a p-value of 0.001 (Mixed Models Analysis).
- For the "Change From Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale From Week 49 Through to Week 52":
- The depemokimab group showed a least squares mean change of -0.76 (Standard Error: 0.079).
- The placebo group showed a least squares mean change of -0.53 (Standard Error: 0.083).
- The difference in least squares means was -0.23 (95.0% CI: -0.46 to 0.0), with a p-value of 0.047 (Mixed Models Analysis).
- For the "Change From Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale From Week 49 Through to Week 52":
- The depemokimab group showed a least squares mean change of -0.71 (Standard Error: 0.084).
- The placebo group showed a least squares mean change of -0.49 (Standard Error: 0.087).
- The difference in least squares means was -0.22 (95.0% CI: -0.46 to 0.02), with a p-value of 0.074 (Mixed Models Analysis).
- For the "Change From Baseline in Mean Symptom Score for Loss of Smell Using Verbal Response Scale From Week 49 Through to Week 52":
- The depemokimab group showed a least squares mean change of -0.48 (Standard Error: 0.069).
- The placebo group showed a least squares mean change of -0.29 (Standard Error: 0.072).
- The difference in least squares means was -0.19 (95.0% CI: -0.39 to 0.0), with a p-value of 0.055 (Mixed Models Analysis).
- For the "Change From Baseline in Lund Mackay Computerized Tomography (CT) Score at Week 52":
- The depemokimab group showed a least squares mean change of -2.8 (Standard Error: 0.45).
- The placebo group showed a least squares mean change of -0.8 (Standard Error: 0.46).
- The difference in least squares means was -2.0 (95.0% CI: -3.3 to -0.8), with a p-value of 0.002 (ANCOVA).
- For the "Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52":
- The depemokimab group showed a least squares mean change of -13.3 (Standard Error: 2.96).
- The placebo group showed a least squares mean change of -6.5 (Standard Error: 3.08).
- The difference in least squares means was -6.8 (95.0% CI: -15.2 to 1.6), with a p-value of 0.113 (Mixed Models Analysis).
What this means
The results indicate that depemokimab demonstrated a statistically significant reduction in total endoscopic nasal polyps score and Lund Mackay CT score compared to placebo in participants with CRSwNP. Improvements in nasal obstruction were also statistically significant. These findings suggest a potential benefit for depemokimab in managing the objective and some subjective symptoms of chronic rhinosinusitis with nasal polyps.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05274750, titled "Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps," were posted on 2025-12-03 on clinicaltrials.gov.