JAMA

Investigational biologic stapokibart reduces nasal polyp burden in phase 3 trial

August 21, 2025

Study details: CROWNS-2 (NCT05436275) was a multicenter, randomized, double-blind, phase 3 trial conducted at 51 hospitals in China, enrolling 180 adults with severe, uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) despite daily intranasal corticosteroids. Key inclusion criteria were prior systemic corticosteroid use or sinonasal surgery, bilateral nasal polyp score ≥5 (scale 0–8), and mean nasal congestion score ≥2 (scale 0–3). After a 4-week run-in with mometasone furoate nasal spray, patients were randomized to stapokibart 300 mg SC or placebo every 2 weeks for 24 weeks, followed by open-label stapokibart for 28 weeks.

Results: At 24 weeks, stapokibart led to significant reduction in nasal polyp score (LS mean difference vs. placebo, −2.3; 95% confidence interval [CI], −2.6 to −1.9; P < 0.001) and nasal congestion score (LS mean difference, −0.7; 95% CI, −0.9 to −0.5; P < 0.001) in the overall population. Efficacy was even greater in patients with eosinophilic CRSwNP. Serious adverse events were rare, but stapokibart was associated with higher rates of arthralgia and hyperuricemia compared with placebo.

Clinical impact: Stapokibart, as an add-on to intranasal corticosteroids, yields a clinically meaningful reduction in polyp size and nasal symptoms for patients with severe, refractory CRSwNP, including those with eosinophilic disease. These results support stapokibart as a promising biologic option in a population with high disease burden and limited alternatives after standard medical and surgical therapy.

Source:

Shen S; CROWNS-2 Study Investigators, et al. (2025, August 18). JAMA. Stapokibart for Severe Uncontrolled Chronic Rhinosinusitis With Nasal Polyps: The CROWNS-2 Randomized Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/40824573/