Идёт набор NCT06455449

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

Фаза III С лечением Polymyositis, Dermatomyositis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Anifrolumab (blinded), Placebo, Anifrolumab (unblinded, open label).
Кому может быть актуально: Состояния в реестре: Polymyositis, Dermatomyositis. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Австрия, Бельгия +24
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

Обзор

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.

Вмешательства

Комбинированный продукт Anifrolumab (blinded)
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Другое Placebo
Matched placebo delivered subcutaneously, once weekly for 52 weeks
Комбинированный продукт Anifrolumab (unblinded, open label)
At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks

Первичные конечные точки

Total Improvement Score (TIS) ≥ 40 response [Срок оценки: 52 week]

Вторичные конечные точки (12)

Manual Muscle Testing 8 (MMT-8) (CSM) [Срок оценки: 52 week]
Oral corticosteroid dose ≤ 7.5 mg/day [Срок оценки: 52 week]
Moderate improvement in disease activity in participants with polymyositis (PM) [Срок оценки: 52 week]
Moderate improvement in disease activity in dermatomyositis (DM) participants. [Срок оценки: 52 week]
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) [Срок оценки: 8 week]
Manual Muscle Testing 8 (MMT-8) in PM participants [Срок оценки: 52 Week]
Manual Muscle Testing 8 (MMT-8) in DM participants [Срок оценки: 52 Week]
Core Set Measures (CSMs) [Срок оценки: 52 week]
Oral corticosteroid dose ≤ 7.5 mg/day in PM participants [Срок оценки: 52 week]
Oral corticosteroid dose ≤ 7.5 mg/day in DM participants [Срок оценки: 52 week]
Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA) [Срок оценки: 8, 24, & 52 week]
5-D itch [Срок оценки: 8, 24, & 52 week]

Критерии участия

Capable of giving informed consent.

Критерии включения

18 - 75 years old
Body weight ≥40 kg
Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
Moderate or severe disease activity per core set measurements.
Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
No history of active tuberculosis or severe COVID-19.
Male and female participants must follow contraception guidelines.

Критерии исключения

Participants with documented inclusion body myositis (IBM), immune mediation necrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years prior to signing the ICF), drug-induced myositis, cancer associated myositis, amyopathic DM, and non inflammatory myopathies (eg, muscular dystrophies).
PM and DM patients at a high risk of malignancy.
Participants with rapidly progressive interstitial lung disease.
Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per the investigator's opinion.
Any history of severe case of herpes zoster infection
History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV .
Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.
Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.
Recent or concurrent enrollment in another clinical study with an investigational product.
Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin 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