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 polyposis
Recipient organisationNIHR University College London Hospitals Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodFeb 2025 — Apr 2028
In plain English
AI plain-English summary
A monthly injection of itepekimab is being tested against placebo in a year-long trial to see if it shrinks nasal polyps and eases congestion in adults whose current treatments are not working. This matters because chronic rhinosinusitis with nasal polyps is a persistent inflammatory condition that often resists standard therapies like steroid sprays, leaving people with blocked noses, lost sense of smell, and poor quality of life. Existing biologic drugs target only one inflammatory pathway, but many patients still have incomplete responses. Itepekimab blocks IL-33, a cytokine involved in both type 2 and non-type 2 inflammation, potentially filling that therapeutic gap. If the trial shows itepekimab safely reduces polyp size and congestion over the treatment period, it could become a new option for patients who have run out of effective treatments. The study also tracks effects on co-morbid conditions such as asthma and aspirin-exacerbated respiratory disease, so success could simplify management of overlapping airway diseases. No cost or patient numbers are specified in the abstract, so the scale of impact remains qualitative.
View original technical description
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 period of 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.
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