Stapokibart for Severe Uncontrolled Chronic Rhinosinusitis With Nasal Polyps: The CROWNS-2 Randomized Clinical Trial.

ABSTRACT:

Importance

Chronic rhinosinusitis with nasal polyps causes severe symptoms and impaired quality of life. Stapokibart is a novel monoclonal antibody that targets interleukin 4Rα.

Objective

To assess the efficacy and safety of stapokibart as an add-on treatment to intranasal corticosteroids in patients with severe uncontrolled chronic rhinosinusitis with nasal polyps.

Design, setting, and participants

From August 9, 2022, to April 28, 2023, this randomized, double-blind, phase 3 clinical trial, conducted at 51 hospitals in China, enrolled adult patients with chronic rhinosinusitis with nasal polyps who had a history of systemic corticosteroid use or sinonasal surgery and a bilateral nasal polyp score of 5 or greater (on a scale of 0-8) and a weekly mean nasal congestion

SUBMITTER: Shen S 

PROVIDER: S-EPMC12362275 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature