Sanofi's (SNY.US) subcutaneous anti-IL-33 antibody has begun a phase III clinical trial in China for chronic sinusitis.

On February 18, the official website of the Drug Clinical Trial Registration and Information Disclosure Platform revealed that Sanofi (SNY.US) had registered a phase III study (CTR20250539) for itepekimab (IL-33 antibody) in the treatment of chronic sinusitis with nasal polyps that is not well controlled. Itepekimab is the first subcutaneous injection IL-33 antibody to enter phase III globally, having previously initiated a phase III clinical trial for chronic obstructive pulmonary disease (COPD). This is the first phase III clinical trial of itepekimab for the chronic sinusitis indication and the first IL-33 antibody to enter phase III in this indication. This is a randomized, double-blind, placebo-controlled, parallel group, 52-week phase III trial designed to evaluate the efficacy, safety, and tolerability of itepekimab in participants with chronic sinusitis with nasal polyps that is not well controlled. The primary endpoint is the change in endoscopic NPS and NCS at 24 weeks compared with baseline. A total of 102 institutions are involved in the trial, with 33 planned to be enrolled in China and 210 in the international group. Interleukin-33 (IL-33) is believed to play a key role in type 1 and type 2 inflammation. Itepekimab is a subcutaneous injection IL-33 antibody developed by Sanofi in collaboration with Regeneron, a fully human monoclonal antibody produced using Regeneron's proprietary VelocImmune technology.