A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) who participated in either EFC18418 or EFC18419 clinical studies

Condition studied

Chronic rhinosinusitis with nasal polyps

Investigational medicinal product(s)

Every trial of Itepekimab across our registers →

Eligibility

Primary endpoint

Incidence of treatment-emergent adverse events (AEs), adverse events of special interest (AESIs), serious adverse events (SAEs), AEs leading to death, and AEs leading to permanent treatment discontinuation

Endpoint detail

Change from baseline of the parent studies (EFC18418, EFC18419) in endoscopic NPS, Change from baseline of the parent studies (EFC18418, EFC18419) in NCS, Functional itepekimab concentration in serum, Incidence of treatment-emergent anti-drug antibody (ADA) responses, Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for chronic rhinosinusitis (CRS), Annualized rate of SCS course or surgery for CRS