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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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522983-33-00
Enrollment
55
Registered
2026-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic rhinosinusitis with nasal polyps

Brief summary

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

Detailed description

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

Interventions

DRUGMatched placebo for test product
DRUGItepekimab

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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—

Secondary

MeasureTime frame
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—

Outcome results

None listed

Source: EU CTIS · Data processed: May 13, 2026