Chronic Sinusitis
EFC18419
Ceren 2
Study 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
Study Duration
- Up to 76 weeks
Number of clinic visits
- Up to 9
Number of phone calls
- Up to 20
Main Entry Criteria
- Over 18 years of age
- History of chronic rhinosinusitis with nasal polyp(s) for at least 1 year
- Prior sinonasal surgery for nasal polyps
- Loss of smell or rhinorrhea (anterior/posterior)
There are additional eligibility requirements to enrol in this study. Our Study Doctor will review the study requirements and discuss your eligibility with you either over the telephone or at your first clinic visit.
Assessments
- ECG
- Blood pressure and pulse
- Blood and urine tests
- Nasal endoscopy
- CT Scan
- Questionnaires
- Spirometry for patients with Asthma
You will receive all study-related procedures, medications, and laboratory services at no cost. In addition, you will be reimbursed per visit for your time and travel.
Study Status
- Recruitment opening soon – Spearwood