LTS18420-CEREN-3
Research type
Research Study
Full title
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
IRAS ID
1013174
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2025-522983-33
Research summary
The double-blinded extension study (LTS18420, EU study number: 2025-522983-33) evaluates the long-term safety and tolerability of itepekimab in adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) who completed treatment in parent studies EFC18418 or EFC18419. CRSwNP is a chronic inflammatory condition characterized by soft growths inside the nose affecting nasal passages and sinuses, causing nasal blockage, smell loss, facial pain/pressure, and nasal discharge that significantly impacts quality of life. This extension study assesses itepekimab's long-term safety profile (primary objective) while monitoring effectiveness through changes in nasal polyp size and CRSwNP symptoms, and measuring blood concentrations over time (secondary objectives). The study includes a 5-day transition period, 52-week treatment period with site visits and phone calls, and 20-week follow-up without medication. Two dosing regimens are tested: participants previously receiving itepekimab continue the same regimen, while those who received placebo are randomly assigned to one of two itepekimab dosing regimens. Itepekimab, administered as subcutaneous injection, is an investigational treatment that binds to interleukin-33, a substance important for immune system function. Eligibility is limited to adults with inadequately controlled CRSwNP who completed parent study treatment periods; exclusions include participants who did not complete parent study treatment, experienced certain medical problems during parent studies, or completed parent studies before site approval.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0378
Date of REC Opinion
23 Jan 2026
REC opinion
Further Information Favourable Opinion