drugset / Trial / NCT05281523

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)

NCT05281523 ↗

Phase 3 Completed 264 enrolled GlaxoSmithKline
RandomizedParallel-groupTriple-blindTreatment

Summary

This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).

Timeline

Start
2022-04-18
Primary completion
2024-07-12
Completion
2024-08-06

Outcome

Met primary endpoint

registry analysis (other test); Depemokimab vs Placebo; p = 0.004; Difference in Least Square Means -0.6 (95% CI -1.0 to -0.2); Mixed Models Analysis NCT05281523 ↗

registry analysis (other test); Depemokimab vs Placebo; p = 0.025; Difference in Least Square Means -0.25 (95% CI -0.46 to -0.03); Mixed Models Analysis NCT05281523 ↗

release “ANCHOR-1 (N=271) and ANCHOR-2 (N=257) met their co-primary endpoints, with twice-yearly administration of depemokimab showing clinically meaningful and statistically significant improvements in nasal polyp size and nasal obstruction, two key clinical measures of disease severity, versus placebo.” gsk.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Depemokimab Protein / enzyme biologic 100 mg Subcutaneous

Indications