Study to Characterise Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Anifrolumab Administered Subcutaneously (SC) or Intravenously (IV)

Официальное название

A Multicentre, Randomised, Open-label, Phase I Study to Characterise the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Administered Subcutaneously or Intravenously in Participants With Systemic Lupus Erythematosus

Обзор

The purpose of this study is to assess the PK, PD, and safety of anifrolumab as SC administration or IV infusion in adult participants with systemic lupus erythematosus (SLE).

Подробное описание

This is a multicentre, randomised, phase I open-label study.

The study will comprise of the following:

* Screening period: Up to 30 days * Two treatment periods * Part A: Randomised SC vs IV Treatment Period: 5 weeks * Part B: Optional Extended Treatment Period: Up to 47 weeks * Safety follow-up period: 12 weeks after the final dose

Part A will include all participants who will be randomised into SC anifrolumab via autoinjector (AI) or IV anifrolumab.

Part B is an optional extended treatment period where participants will receive SC anifrolumab via accessorised prefilled syringe (aPFS).

Вмешательства

• Комбинированный продукт Anifrolumab: SC formulation via AI
  Anifrolumab will be administered subcutaneously via an AI.
• Комбинированный продукт Anifrolumab: IV formulation
  Anifrolumab will be administered intravenously.
• Комбинированный продукт Anifrolumab: SC formulation via aPFS
  Anifrolumab will be administered subcutaneously via an aPFS.

Первичные конечные точки

• Anifrolumab serum concentrations through Week 4 [Срок оценки: Up to Week 4]

Вторичные конечные точки (1)

• Percentage change from baseline in Type I interferon (IFN) 21-gene expression PD marker [Срок оценки: Up to Week 4]

Критерии участия

Критерии включения

• Participants who have a diagnosis of adult SLE according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 criteria for ≥ 24 weeks prior to signing the informed consent form (ICF).
• "Clinical" Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥ 4 points at Screening.
• Antinuclear antibody (ANA)-positive at Screening.
• Must be on stable background standard therapy with oral corticosteroids (OCS), antimalarials, and/or immunosuppressants alone or in combination.

Критерии исключения

• Active severe or unstable neuropsychiatric SLE.
• Active severe SLE-driven renal disease.
• Known history of primary immunodeficiency, splenectomy, or any underlying condition predisposing to infection, or a positive result for Human Immunodeficiency Virus (HIV) infection confirmed by central laboratory at Screening.
• At Screening, confirmed positive test for hepatitis B serology or positive test for hepatitis C antibody.
• Any severe case of herpes zoster infection at any time prior to Week 0 (Day 1).
• Opportunistic infection requiring hospitalisation or IV antimicrobial treatment within 3 years of randomisation
• History of cancer, apart from:

• Squamous or basal cell carcinoma of the skin treated with documented curative success ≥ 3 months prior to Day 1.
• Cervical cancer in situ treated with apparent curative success ≥ 1 year prior to Day 1.

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07688980 · D3466C00003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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