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Itepekimab in Chronic Rhinosinusitis With Nasal Polyps
NCT06834347Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Feb 2025
- Primary completion
- Sep 2026
- Countries
- 21
- Sponsor
- Sanofi
- Modality
- Monoclonal Antibodies
- Drugs
- itepekimab
- Conditions
- chronic rhinosinusitis with nasal polyps (CRSwNP)
01
Overview
Phase 3, randomised, double-blind trial of itepekimab in chronic rhinosinusitis with nasal polyps (CRSwNP) (3 arms), sponsored by Sanofi. Primary endpoints: Nasal Polyp Score at 24 weeks and Nasal Congestion Score at 24 weeks. Started Feb 2025; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Itepekimab high dose
Subcutaneous administration of Itepekimab high dose for 52 weeks + Mometasone furoate nasal spray
Itepekimab low dose
Subcutaneous administration of Itepekimab low dose for 52 weeks + Placebo + Mometasone furoate nasal spray
Placebo
Subcutaneous administration of matching placebo for 52 weeks + Mometasone furoate nasal spray
03
Who it enrols
Adults with inadequately controlled CRSwNP for at least 1 year, with prior sinonasal surgery or recent systemic corticosteroid use, and a minimum Nasal Polyp Score of 5.
04
Endpoints
Primary
Nasal Polyp Score
Nasal Congestion Score
Secondary
Nasal Polyp Score
Nasal Congestion Score
Lund-Mackay score
Total Symptom Score
Loss of smell severity score and UPSIT score
Sino-Nasal Outcome Test-22
PROMIS Sleep Disturbance Short Form 8b
Proportion of participants requiring systemic corticosteroids or surgery
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