An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps

Condition(s) studied

Investigational drug(s) / intervention(s)

Itepekimab (SAR440340): Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

Placebo: Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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 — Baseline to EOS (Week 72)
  All AEs (serious or nonserious) will be collected from the signing of the ICF until end of study (EOS) visit

Trial sites (46)

+ 6 more sites — see the full list on the official registry below.

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