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An extension study to investigate the long-term safety and tolerability of itepekimab in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Chronic rhinosinusitis with nasal polyps
Date of first enrollment	14/08/2026
Target sample size	380
Countries of recruitment	Australia,Japan,Chile,Japan,China,Japan,South Korea,Japan,United Kingdom,Japan,United States,Japan
Study type	Interventional
Intervention(s)	Drug: Itepekimab (SAR440340, REGN3500) Pharmaceutical form: Solution for injection in prefilled syringe, Route of administration: Subcutaneous (SC) Drug: Placebo Pharmaceutical form: Solution for injection in prefilled syringe, Route of administration: SC Study Arms: Experimental: Itepekimab high dose - SC administration of Itepekimab high dose for 52 weeks. - - Interventions: Itepekimab Experimental: Itepekimab low dose - SC administration of Itepekimab low dose for 52 weeks. - - Interventions: Itepekimab, Placebo

Outcome(s)

Primary Outcome

1. 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 [Time Frame: Baseline to end of study (EOS) (Week 72)] All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until EOS visit.

Secondary Outcome

1. Change from baseline of the parent studies (EFC18418, EFC18419) in endoscopic Nasal Polyp Score (NPS) [Time Frame: Baseline to Week 52] 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). 2. Change from baseline of the parent studies (EFC18418, EFC18419) in Nasal Congestion Score (NCS) [Time Frame: Baseline to EOS (Week 72)] The NCS is scored using a 0 to 3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. 3. Functional itepekimab concentration in serum [Time Frame: Baseline to EOS (Week 72)] 4. Incidence of treatment-emergent anti-drug antibody (ADA) responses [Time Frame: Baseline to EOS (Week 72)] 5. Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for chronic rhinosinusitis (CRS) [Time Frame: Baseline up to Week 52] 6. Annualized rate of SCS course or surgery for CRS [Time Frame: Baseline up to Week 52]

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Participants with CRSwNP who completed the 52-weeks intervention period in a previous itepekimab CRSwNP Phase 3 clinical study (ie, EFC18418 or EFC18419) and for which an end of treatment (EOT) visit occurred no later than 5 days before the enrollment visit of this study. - A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - - Is not a women of childbearing potential (WOCBP), OR - - Is a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention.
Exclude criteria	- Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin. - Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status. - Anaphylactic reactions or systemic allergic reactions that are related to investigational medicinal product (IMP) and require treatment during the parent study. - Any other situation that led to a permanent premature IMP discontinuation in parent trials. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.