This is a double-blind, parallel-group, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both new or continued treatment with itepekimab 300 mg SC high dose or itepekimab 300 mg SC low dose in participants with CRSwNP having completed the intervention period of the clinical studies EFC18418 or EFC18419. A secondary purpose of this study is to provide efficacy outcomes beyond the intervention period of the parent trials EFC18418 and EFC18419. Study details include: * The study duration will be up to 72 weeks. * The intervention duration will be 52 weeks. * A follow-up period of 20 weeks will be conducted. * The number of visits will be 8 and the number of phone contacts will be 4.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
380
Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
Velocity Clinical Research - San Diego- Site Number : 8402041
La Mesa, California, United States
Allergy, Asthma and Clinical Research- Site Number : 8402002
Oklahoma City, Oklahoma, United States
Investigational Site Number : 0362001
Spearwood, Western Australia, Australia
Investigational Site Number : 1241001
Québec, Quebec, Canada
Investigational Site Number : 1521003
Talca, Maule Region, Chile
Investigational Site Number : 1522003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1521002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1562001
Beijing, China
Investigational Site Number : 1562004
Chengdu, China
Investigational Site Number : 1562008
Jingzhou, China
...and 5 more locations
Incidence of treatment-emergent adverse events (AEs), adverse events of special interest (AESIs), serious adverse events (SAEs), AEs leading to death, and AEs leading to permanent treatment discontinuation
All AEs (serious or nonserious) will be collected from the signing of the ICF until end of study (EOS) visit
Time frame: Baseline to EOS (Week 72)
Change from baseline of the parent studies (EFC18418, EFC18419) in endoscopic NPS
The Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Nasal polyp is graded based on polyp size from 0 to 4 with higher scores indicating larger polyps. The sum of right and left nostril scores ranges from 0 (no polyps) to 8 (large polyps).
Time frame: Baseline to Week 52
Change from baseline of the parent studies (EFC18418, EFC18419) in NCS
The Nasal Congestion Score (NCS) is scored using a 0 to 3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms.
Time frame: Baseline to EOS (Week 72)
Functional itepekimab concentration in serum
Time frame: Baseline to EOS (Week 72)
Incidence of treatment-emergent anti-drug antibody (ADA) responses
Time frame: Baseline to EOS (Week 72)
Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for chronic rhinosinusitis (CRS)
Time frame: Baseline up to Week 52
Annualized rate of SCS course or surgery for CRS
Time frame: Baseline up to Week 52
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