CEREN-2
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, parallel-group, 52-week Phase 3 trial to investigate the efficacy, safety, and tolerability of itepekimab in adult participants with inadequately-controlled chronic rhinosinusitis with nasal polyps
IRAS ID
1011079
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2024-516815-26
Research summary
This Phase 3 study investigates the efficacy, safety, and tolerability of itepekimab, an anti-IL-33 monoclonal antibody, in adult participants ((≥18 years of age) with chronic rhinosinusitis with nasal polyps (CRSwNP). CRSwNP is characterized by persistent inflammation in the nasal mucosa, and current treatments often provide incomplete relief. The study aims to assess whether blocking IL-33, a cytokine involved in inflammatory responses, can improve nasal polyp size, nasal congestion, sinus opacification, and overall quality of life.
This study consists of three periods with a study duration of approximately 76 weeks for all participants:
• Screening run in on MFNS for 4 weeks.
• Randomized itepekimab/placebo intervention period (52 weeks).
• Post IMP treatment safety follow-up (20 weeks).Key details of the study include:
Design: A double-blind, placebo-controlled trial with 3 parallel groups.
Primary objectives: To measure changes in nasal polyp size and nasal congestion after 24 and 52 weeks of treatment.
Secondary objectives: To evaluate changes in sinus opacification, symptoms, sense of smell, quality of life, and the effect on co-morbid conditions like asthma and aspirin-exacerbated respiratory disease (AERD). Long-term efficacy will be assessed up to 52 weeks.
Study interventions: Participants will receive subcutaneous (SC) injections of itepekimab (300 mg every 2 weeks) or placebo. Concurrent treatments include mometasone furoate nasal spray (MFNS).
Endpoints: Include both efficacy (e.g., changes in nasal polyps and congestion) and safety (e.g., incidence of treatment-emergent adverse events).
The study explores the potential of itepekimab as a novel treatment option for CRSwNP by targeting both type 2 and non-type 2 inflammatory pathways, filling a therapeutic gap where other biologics have shown incomplete responses.REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0756
Date of REC Opinion
5 Dec 2024
REC opinion
Further Information Favourable Opinion