Идёт набор NCT05895786

A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]

Фаза III С лечением Myositis

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: PF-06823859, Placebo.
Кому может быть актуально: Состояния в реестре: Myositis. Базовые параметры: от 18 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, Болгария, Китай, Франция +15
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 PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS)

Обзор

The purpose of the study is to understand how the study medicine PF-06823859 (dazukibart) works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM. This study is seeking participants who: * Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater * Have active DM or active PM. * Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant. * Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body. Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position. Some of the participants will receive the study medicine (dazukibart) and some will receive placebo (which is similar to study medicine but contains no medicine in it). The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about 1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both dazukibart and placebo and will be given at the study site. The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if dazukibart is safe and effective. Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site.

Вмешательства

Препарат PF-06823859
anti-interferon beta therapy
Препарат Placebo
Placebo for PF-06823859

Первичные конечные точки

Moderate change in Total Improvement Score (TIS) [Срок оценки: 24 weeks outside of the United States (US) and 52 weeks in the US]

Вторичные конечные точки (9)

Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8) [Срок оценки: 24 weeks outside of the US and 52 weeks in the US]
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in participants with dermatomyositis (DM) [Срок оценки: Week 24 outside the US]
Change from baseline in Investigator Global Assessment severity scale (IGA) in participants with dermatomyositis [Срок оценки: 24 and 52 weeks in the US only]
Corticosteroid (CS) dose assessment [Срок оценки: 52 weeks]
Moderate change in Total Improvement Score [Срок оценки: 24 weeks in the US and 52 weeks outside of the US]
Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF) [Срок оценки: 24 weeks outside of the US and 52 weeks in the US]
Change from baseline in 5-D Itch Scale Score [Срок оценки: 24 weeks outside of the US and 52 weeks in the US]
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [Срок оценки: 24 weeks outside of the US and 52 weeks in the US]
Response in corticosteroid tapering [Срок оценки: 52 weeks US only]

Критерии участия

Критерии включения

Male or female adults (≥18 years old or minimum legal adult age as defined per local regulation, whichever is greater)
Active dermatomyositis (DM) or polymyositis (PM) with age of onset

18 years old.
Must be receiving a stable dose of standard of care (SOC) background medications at the time of enrollment.

Критерии исключения

Myositis due to non-Idiopathic inflammatory myopathies (non-IIM)
Existing diagnosis of inclusion body myositis (IBM)
Presence of immune-mediated necrotizing myositis (IMNM)
Myositis with end-stage organ involvement
Active bacterial, viral or fungal infections or hospitalizations for serious infections within 60 days prior to enrollment
History of recurrent bacterial, viral, fungal, mycobacterial or other infections
Clinically significant finding on a chest x-ray
Have cancer or a history of cancer within 5 years of screening
Significant current or prior disease conditions that may interfere with the response to or safety of the study medicine, including but not limited to:
history of major organ transplant
acute coronary syndrome or any history of significant cerebrovascular disease within 24 weeks of screening
preexisting demyelinating disorder such as multiple sclerosis, or other severe neurological disorder
major surgery within 4 weeks of screening, or scheduled to occur during the study, excluding diagnostic surgery
previous treatment with total lymphoid irradiation
history of any lymphoproliferative disorder such as Epstein Barr Virus, history of lymphoma, leukemia, or symptoms of current lymphatic or lymphoid disease
Clinically significant depression, suicidal ideation, or previous history of suicidal behaviors
Other medical or laboratory abnormality that may increase the risk of study participation
Previous administration with an investigational product (drug or vaccine) within 30 days or of the first dose of study medicine
Current use or incomplete appropriate washout period of any prohibited medication(s) or known exposure to anti-interferon beta (PF-06823859) or any type of anti-interferon beta therapy
Prior SOC medication that does not fulfill the criteria
Certain laboratory results from screening assessments that may interfere with study participation.
Investigator site staff directly involved in the conduct of the study and their family members, site staff and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members

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 · 47 центров

Arizona Arthritis & Rheumatology Research, PLLC — Glendale
Neuromuscular Research Center — Phoenix
Mayo Clinic Hospital — Phoenix
Mayo Clinic in Arizona - Scottsdale — Scottsdale
200 UCLA Medical Plaza — Los Angeles
UCLA Clinical & Translational Research Center (CTRC) — Los Angeles
UCLA — Los Angeles
Center for Clinical Research - Chapman Pavilion — Orange
… и ещё 39 центров

Китай · 21 центр

Anhui Provincial Hospital — Хэфэй
China-Japan Friendship Hospital — Пекин
Peking Union Medical College Hospital — Пекин
Dongguan People's Hospital — Дунгуань
Guangdong Provincial People's Hospital — Гуанчжоу
Cangzhou People's Hospital — Cangzhou
Xiangya Hospital Central South University — Чанша
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School — Нанкин
… и ещё 13 центров

Япония · 12 центров