Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

Официальное название

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)

Обзор

This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy. The study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells/ microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy. Participants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.

Вмешательства

• Препарат Depemokimab
  Depemokimab will be administered.
• Другое Placebo
  Matching placebo will be administered.

Первичные конечные точки

• Frequency of HES flares [Срок оценки: Up to 52 weeks]

Вторичные конечные точки (3)

• Time to first HES flare [Срок оценки: Up to 52 weeks]
• Number of participants with at least one HES flare during the 52-week study intervention period [Срок оценки: Up to 52 weeks]
• Change from Baseline to Week 52 in weekly average score of Brief Fatigue Inventory (BFI) item 3 (worst fatigue in last 24 hours) [Срок оценки: Baseline and up to Week 52]

Критерии участия

Критерии включения

• Participants who are greater than or equal (>=) 40 kilogram (kg) at Screening Visit 1.
• Participants who have a documented diagnosis of HES prior to Visit 2.
• A history of 2 or more HES flares within the past 12 months prior to Visit 1.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: a) woman of non-childbearing potential (WONCBP) Or b) woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<) 1 percentage (%).
• Capable of giving signed informed consent.

Критерии исключения

• Participants with HES disease manifestations which in the opinion of the investigator may put the participant at unacceptable risk from study participation or confound interpretation of efficacy or safety data.
• Participants with chronic or ongoing active infections requiring systemic treatment or a pre-existing parasitic infestation within 6 months prior to Visit 1.
• Participants with a known immunodeficiency (e.g., Human Immunodeficiency Virus \[HIV\]), other than that explained by the use of OCS or other therapy taken for HES.
• Participants with a history of or current lymphoma.
• Participants with current malignancy or previous history of cancer in remission for less than 5 years prior to Visit 1. Participants that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded.
• Participants with a haematologic malignancy with hypereosinophilia in which HES is not the primary diagnosis, e.g., chronic myeloid leukaemia, myelodysplastic syndrome, chronic eosinophilic leukaemia-not otherwise specified.
• Cirrhosis or current unstable liver or biliary disease per investigator assessment.
• Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment.
• Participants with current diagnosis of vasculitis.
• Hypereosinophila with no clinical symptoms and/or proof of organ dysfunction.
• Clinical diagnosis of Eosinophilic granulomatosis with polyangiitis (EGPA).
• Participants with an allergy/ intolerance to a monoclonal antibody or biologic, or any of the excipients of the investigational product.
• Participants who have a previous documented failure with anti-interleukin (IL)-5/5R therapy.
• Participants who have received monoclonal antibodies (mAb) within 30 days or 5 half-lives, whichever is longer, prior to Visit 1.
• Participants who test positive for the FIP1L1-PDGFRα fusion gene.
• QT interval corrected for heart rate according to Fridericia's formula (QTcF) ≥450 milliseconds (msec) or QTcF ≥480 msec for participants with Bundle Branch Block at Screening Visit 1.
• Participants who are not responsive to OCS based on clinical response or blood eosinophil counts in the opinion of the Investigator.
• Participants who are pregnant or breastfeeding.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 11 центров

• GSK Investigational Site — San Diego
• GSK Investigational Site — Atlanta
• GSK Investigational Site — Boston
• GSK Investigational Site — Southfield
• GSK Investigational Site — Rochester
• GSK Investigational Site — Manhasset
• GSK Investigational Site — Cincinnati
• GSK Investigational Site — Columbus
• … и ещё 3 центра

Япония · 11 центров

• GSK Investigational Site — Aomori
• GSK Investigational Site — Aomori
• GSK Investigational Site — Chiba
• GSK Investigational Site — Gifu
• GSK Investigational Site — Hyōgo
• GSK Investigational Site — Kanagawa
• GSK Investigational Site — Miyagi
• GSK Investigational Site — Tokyo
• … и ещё 3 центра

South Korea · 10 центров

• GSK Investigational Site — Gwangju
• GSK Investigational Site — Jeonju
• GSK Investigational Site — Kangwondo
• GSK Investigational Site — Seoul
• GSK Investigational Site — Seoul
• GSK Investigational Site — Seoul
• GSK Investigational Site — Seoul
• … и ещё 3 центра

Китай · 9 центров

• GSK Investigational Site — Пекин
• GSK Investigational Site — Чанша
• GSK Investigational Site — Гуанчжоу
• GSK Investigational Site — Гуанчжоу
• GSK Investigational Site — Харбин
• GSK Investigational Site — Nanchang
• GSK Investigational Site — Шанхай
• GSK Investigational Site — Сучжоу
• … и ещё 1 центр

Италия · 9 центров

• GSK Investigational Site — Bologna
• GSK Investigational Site — Catania
• GSK Investigational Site — Milan
• GSK Investigational Site — Naples
• GSK Investigational Site — Novara
• GSK Investigational Site — Pavia
• GSK Investigational Site — Roma
• GSK Investigational Site — Treviso
• … и ещё 1 центр

Испания · 8 центров

Список центров уточняется — проверьте первичный протокол.

Аргентина · 5 центров

• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Florida
• GSK Investigational Site — La Plata
• GSK Investigational Site — Mar del Plata
• GSK Investigational Site — Quilmes

Бразилия · 4 центра

• GSK Investigational Site — Porto Alegre
• GSK Investigational Site — Blumenau
• GSK Investigational Site — Rio de Janeiro
• GSK Investigational Site — Sorocaba

Чехия · 4 центра

• GSK Investigational Site — Brno-Bohunice
• GSK Investigational Site — Hradec Králové
• GSK Investigational Site — Prague
• GSK Investigational Site — Ústí nad Labem

Мексика · 3 центра

• GSK Investigational Site — Guadalajara
• GSK Investigational Site — Monterrey
• GSK Investigational Site — Veracruz

Румыния · 3 центра

• GSK Investigational Site — Bucharest
• GSK Investigational Site — Bucharest
• GSK Investigational Site — Cluj-Napoca

Канада · 2 центра

• GSK Investigational Site — Ottawa
• GSK Investigational Site — Toronto

Германия · 2 центра

• GSK Investigational Site — Bad Bramstedt
• GSK Investigational Site — Mannheim

Греция · 2 центра

• GSK Investigational Site — Athens
• GSK Investigational Site — Rio Patras

Израиль · 2 центра

• GSK Investigational Site — Ramat Gan
• GSK Investigational Site — Tel Aviv

Польша · 2 центра

• GSK Investigational Site — Chęciny
• GSK Investigational Site — Lodz

Австралия · 1 центр

• GSK Investigational Site — Garran

Бельгия · 1 центр

• GSK Investigational Site — Brussels

Дания · 1 центр

• GSK Investigational Site — Odense C

Гонконг · 1 центр

• GSK Investigational Site — Pokfulam

Великобритания · 1 центр

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Идентификаторы

NCT: NCT05334368 · 217013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗