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Набира участници NCT07294170

ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis

Заболявания: Myasthenia Gravis MG gMG Generalized Myasthenia Gravis Generalized Myasthenia Gravis (gMG) AChR-Ab Seropositive Generalized Myasthenia Gravis

Спонсор: argenx

Налично на: БГ
Обобщение
ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.
Описание
This is a platform study and is governed by a single master protocol that enables multiple regimens to be evaluated in separate intervention-specific appendixes (ISAs). The key design structure of the platform study comprises: common master protocol screening period, ISA-specific screening period, ISA treatment period of variable duration and design and ISA safety follow-up/follow-up period of variable duration. Details on each study period will be specified in the ISAs. Following ISAs are included in this platform study: * NCT07284420 - ADAPT Forward 1 - a study to evaluate empasiprubart IV as add-on therapy to efgartigimod IV in participants with AChR-Ab seropositive generalized myasthenia gravis with a partial clinical response to efgartigimod (https://www.clinicaltrials.gov/study/NCT07284420)
Кой може да участва
Inclusion Criteria: * Is at least 18 years of age and the local legal age of consent for clinical studies * Has been diagnosed with MG with consistent clinical features per the investigator's clinical judgment * If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening Exclusion Criteria: * Known autoimmune disease or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk * Is MGFA (Myasthenia Gravis Foundation of America) Class V
Интервенции
Efgartigimod IV
BIOLOGICAL
Empasiprubart IV
BIOLOGICAL
Места на провеждане 10
Белгия (1)
UZ Leuven - PPDS
Leuven
Полша (3)
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Centrum Medyczne Neurologia Slaska
Katowice , Silesian Voivodeship
Krakowska Akademia Neurologii Sp. z o.o.
Krakow , Lesser Poland Voivodeship
Испания (1)
Hospital Regional Universitario de Malaga - Hospital General
Málaga , Malaga
Guillermina García Martín, MD
САЩ (5)
Dent Neurologic Institute - Amherst
Amherst , New York
National Neuromuscular Research Institute
Austin , Texas
Profound Research LLC - Carlsbad
Carlsbad , California
Erlanger Health System
Columbia , Maryland
Visionary Investigators Network
Miami , Florida
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
19.12.2025
Крайна дата
07.03.2028
Регистрационен номер
NCT07294170
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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