This is a randomized, multicenter, double-blind, Phase 3 study with 2 parallel groups. The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different dosing regimens of itepekimab monotherapy in Japanese participants aged 18 years or older with chronic rhinosinusitis with nasal polyp(s) (CRSwNP) who are not adequately controlled despite previous surgery and/or treatment with systemic corticosteroid(s) (SCS). The total study duration par participant is approximately 76 week, including: * A screening period for up to 4 weeks. * A randomized study intervention period for up to 52 weeks * A post-intervention safety follow-up for up to 20 weeks * The number of visits will be 9 site visits and 20 phone/home visits
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
Change from baseline in the 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 24
Change from baseline in the NCS
The Nasal Congestion Score (NCS) is scored using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. Outcome value is defined as the preceding 28-day average of morning scores recorded in eDiary.
Time frame: Baseline to Week 24
Proportion of NPS responders (defined as participants with improvement by at least 1 points in NPS)
Time frame: Week 24 and Week 52
Change from baseline in endoscopic NPS
The 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 in NCS
The NCS is scored using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. Outcome value is defined as the preceding 28-day average of morning scores recorded in eDiary.
Time frame: Baseline to Week 52
Change from baseline in the TSS (nasal congestion/obstruction, anterior/posterior rhinorrhea, and loss of sense of smell)
The CRSwNP Total Symptom Score (TSS) is a composite score derived from nasal congestion (NC)/obstruction, anterior/posterior rhinorrhea,and loss of smell. The total score ranges from 0 to 9 with higher scores on TSS indicating greater overall symptom severity.
Time frame: Baseline to Weeks 24 and 52
Change from baseline in loss of smell severity score using the daily CRSwNP sinonasal symptom eDiary
The CRSwNP sinonasal symptom diary is designed to assess the severity of chronic rhinosinusitis (CRS) sinonasal symptoms on daily basis. These symptoms include NC/obstruction, anterior rhinorrhea and posterior rhinorrhea, facial pain/pressure, loss of smell, and headache. Each of the individual items of the diary are scored from 0 ("No symptoms") to 3 ("Severe symptoms - symptoms that are hard to tolerate, cause interference with activities or daily living"). Higher scores on the items of the individual symptoms denote greater symptom severity.
Time frame: Baseline to Weeks 24 and 52
Incidence of TEAEs, TESAEs, TEAESIs and TEAEs leading to treatment discontinuation
Treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events of special interest (TEAESIs)
Time frame: Baseline to End of Study (EOS) (Week 72)
Itepekimab concentration in serum
Time frame: Baseline to EOS (Week 72)
Incidence of treatment-emergent antidrug antibody (ADA) responses
Time frame: Baseline to EOS (Week 72)
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