Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)

Summary

This was a Phase 4, open-label, single-arm, multicenter study to evaluate the efficacy and safety of dupilumab subcutaneous (SC) injection monotherapy in Japanese participants aged 18 or older with CRSwNP that is not adequately controlled with existing therapies. Duration of study period (per participant): * Screening Period (2 to 4 weeks) * Intervention Period (up to 52 weeks±3 days)

Timeline

Start

2021-10-22

Primary completion

2022-12-21

Completion

2023-07-05

Publications

• Fujieda S, Takabayashi T, Ohta N, Yoshikawa M, Kibe Y, Ishida M, Suzuki K, Takahashi Y, Amin N, Wright L, Robinson L, Yahata K. Effectiveness and Safety of Dupilumab Monotherapy in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyps. Laryngoscope. 2025 Dec;135(12):4625-4632. doi: 10.1002/lary.70037. Epub 2025 Aug 30.

Drugs

Indications