Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study

Официальное название

A Single-arm Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study

Обзор

This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207). The study duration will be up to approximately 148 weeks per participant, including 144 weeks of treatment period and 4 weeks of follow-up.

Вмешательства

• Препарат Lunsekimig
  * Pharmaceutical form: solution for injection * Route of administration: subcutaneous
• Препарат Mometasone furoate nasal spray (MFNS)
  * Pharmaceutical form: Solution for administration via spray pump * Route of administration: intranasal spray

Первичные конечные точки

• Incidence of participants with treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESI), and serious adverse events (SAEs) [Срок оценки: From baseline to Week 148]

Вторичные конечные точки (5)

• Change in Sino-nasal Outcome Test 22 (SNOT-22) total score [Срок оценки: From the parent study baseline to Weeks 52, 96 and 144]
• Change in Rhinosinusitis visual analog scale (VAS) [Срок оценки: From the parent study baseline to Weeks 52, 96 and 144]
• Change in The University of Pennsylvania Smell Identification Test (UPSIT) score [Срок оценки: From the parent study baseline to Weeks 52, 96 and 144]
• Serum lunsekimig concentrations [Срок оценки: From baseline to Week 144]
• Anti-drug antibodies (ADA) against lunsekimig [Срок оценки: From baseline to Week 144]

Критерии участия

Критерии включения

• Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol
• Participants receiving therapy with intranasal mometasone furoate nasal spray (MFNS)
• Participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures

Критерии исключения

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

• Prior hypersensitivity reaction to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
• Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant

The above information is not intended to contain all considerations relevant to a patient'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

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 9 центров

• Modena Allergy + Asthma- Site Number : 8400005 — La Jolla
• Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003 — Roseville
• Treasure Valley Medical Research- Site Number : 8400002 — Boise
• Essential Medical Research- Site Number : 8400020 — Tulsa
• McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400 — Bellaire
• Pharmaceutical Research & Consulting- Site Number : 8400004 — Dallas
• ENT Associates of Texas - McKinne- Site Number : 8400014 — McKinney
• Alamo ENT Associates- Site Number : 8400001 — San Antonio
• … и ещё 1 центр

Польша · 6 центров

• Investigational Site Number : 6160004 — Poznan
• Investigational Site Number : 6160002 — Krakow
• Investigational Site Number : 6160007 — Wroclaw
• Investigational Site Number : 6160001 — Warsaw
• Investigational Site Number : 6160005 — Warsaw
• Investigational Site Number : 6160003 — Katowice

Аргентина · 3 центра

• Investigational Site Number : 0320002 — Rosario
• Investigational Site Number : 0320001 — Buenos Aires
• Investigational Site Number : 0320003 — Mendoza

Великобритания · 3 центра

• Investigational Site Number : 8260004 — Gloucester
• Investigational Site Number : 8260003 — Manchester
• Investigational Site Number : 8260001 — Newcastle upon Tyne

Бельгия · 2 центра

• Investigational Site Number : 0560002 — Ghent
• Investigational Site Number : 0560001 — Leuven

Болгария · 1 центр

• Investigational Site Number : 1000001 — Sofia

Идентификаторы

NCT: NCT06914908 · LTS18300 · 2024-515912-27 · U1111-1308-9807

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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