NCT05049122: SINUS-M52: dupilumab for chronic rhinosinusitis in Japan

NCT05049122 is SINUS-M52, an open-label, single-arm study of dupilumab monotherapy in 25 Japanese patients with chronic rhinosinusitis with nasal polyps. It evaluated treatment without concomitant intranasal corticosteroids over 52 weeks. 1 2

At week 24, 23 of 25 patients—92%, 95% CI 72.5%–98.6%—had at least a one-point improvement in nasal-polyp score. Mean changes included approximately −2.4 points in polyp score, −1.58 in nasal congestion and −5.6 in Lund–Mackay CT score. These are within-group changes, not effects relative to an untreated comparison. 2

Treatment-emergent adverse events occurred in 11/25 patients (44%). The report describes one serious adverse event judged unrelated to treatment, no deaths and no permanent treatment discontinuation due to adverse events. The absence of a control group and small sample limit causal and comparative conclusions; the study does not establish superiority over surgery, another biologic or combination treatment. 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT05049122. Original registration; establishes the exact study identity and registered methods.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT05049122. Original registration; establishes the exact study identity and registered methods.

2. Fujieda et al. (2025), The Laryngoscope. Original SINUS-M52 report; DOI 10.1002/lary.70037. Supports efficacy measurements, denominators and reported safety outcomes — Fujieda et al. (2025), The Laryngoscope. Original SINUS-M52 report; DOI 10.1002/lary.70037. Supports efficacy measurements, denominators and reported safety outcomes.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.