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

Официальное название

A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Participated in Either EFC18418 or EFC18419 Clinical Studies

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 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 [Срок оценки: Baseline to EOS (Week 72)]

Вторичные конечные точки (6)

• Change from baseline of the parent studies (EFC18418, EFC18419) in endoscopic NPS [Срок оценки: Baseline to Week 52]
• Change from baseline of the parent studies (EFC18418, EFC18419) in NCS [Срок оценки: Baseline to EOS (Week 72)]
• Functional itepekimab concentration in serum [Срок оценки: Baseline to EOS (Week 72)]
• Incidence of treatment-emergent anti-drug antibody (ADA) responses [Срок оценки: Baseline to EOS (Week 72)]
• Proportion of participants with CRSwNP requiring systemic corticosteroid(s) (SCS) or surgery for chronic rhinosinusitis (CRS) [Срок оценки: Baseline up to Week 52]
• Annualized rate of SCS course or surgery for CRS [Срок оценки: Baseline up to Week 52]

Критерии участия

Критерии включения

• 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 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.

Критерии исключения

Participants are excluded from the study if any of the following criteria apply:

• 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 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• Investigational Site Number : 1562012 — Baotou
• Investigational Site Number : 1562001 — Пекин
• Investigational Site Number : 1562004 — Чэнду
• Investigational Site Number : 1562008 — Jingzhou
• Investigational Site Number : 1562006 — Шэньян
• Investigational Site Number : 1562010 — Taiyuan

Чили · 5 центров

• Investigational Site Number : 1522001 — Concepción
• Investigational Site Number : 1521003 — Talca
• Investigational Site Number : 1522003 — Santiago
• Investigational Site Number : 1521002 — Santiago
• Investigational Site Number : 1521001 — Santiago

Канада · 3 центра

• Investigational Site Number : 1241001 — Québec
• Investigational Site Number : 1242003 — Québec
• Investigational Site Number : 1242012 — Québec

США · 2 центра

• Velocity Clinical Research - San Diego- Site Number : 8402041 — La Mesa
• Allergy, Asthma and Clinical Research- Site Number : 8402002 — Oklahoma City

South Korea · 2 центра

• Investigational Site Number : 4101003 — Seoul
• Investigational Site Number : 4101001 — Seoul

Великобритания · 2 центра

• Investigational Site Number : 8262002 — Wigan
• Investigational Site Number : 8261004 — Bradford

Австралия · 1 центр

• Investigational Site Number : 0362001 — Spearwood

Чехия · 1 центр

• Investigational Site Number : 2032001 — Prague

Венгрия · 1 центр

• Investigational Site Number : 3481002 — Budapest

Идентификаторы

NCT: NCT07424144 · LTS18420 · 2025-522983-33 · U1111-1320-4430

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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