- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07583641
A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults (Polaris)
A Global, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult and Adolescent Participants With Autoimmune Encephalitis
The POLARIS study is designed to evaluate how well efgartigimod PH20 SC may work (called "efficacy") and how safe it is for people diagnosed with Autoimmune Encephalitis (AIE). The study consists of 4 parts: in part A participants will receive efgartigimod SC; in part B, participants will be randomized to receive either efgartigimod SC or placebo; in part C, participants who completed part B will receive efgartigimod SC; in part D, participants who completed part C will be observed after their last dose of efgartigimod SC. If AIE symptoms return, efgartigimod SC treatment may be restarted during this time.
The maximum overall study duration for participants is up to 3 years. More information can be found in clinicaltrials.argenx.com/polaris
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Контакты и местонахождение
Контакты исследования
- Имя: Sabine Coppieters, MD
- Номер телефона: 857-350-4834
- Электронная почта: clinicaltrials@argenx.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Is at least 12 years of age.
- Meeting at least the criteria for possible AIE according to the Graus criteria.
- Part A:
Must not have received prior treatment for AIE with PLEX or Ig (participants may have received glucocorticoids); and must not have received PLEX or Ig for any other medical condition in the last 3 months
- Part B: Either completing Part A, or If directly entering Part B, must have received first-line treatment for AIE (i.e. corticosteroids, PLEX, and/or Ig) and have a CASE score of 3 or higher, or a score of 2 or higher in a single sub-item
Exclusion Criteria:
- Known anti-myelin oligodendrocyte glycoprotein (anti-MOG) antibody positivity.
- Any medical condition that would interfere with an accurate assessment of clinical symptoms of AIE.
- Recent major surgery (within 3 months of screening) or intention to have major surgery during the study, except for surgeries for AIE-related teratomas and thymomas.
- History (within 12 months before screening) of current alcohol, drug (including recreational or prescribed cannabinoids), or medication abuse.
- Psychiatric or cognitive impairment unrelated to AIE.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Part A (Open-Label Lead-in Period): Efgartigimod PH20 SC
All participants will receive efgartigimod PH20 SC open label for 8 weeks
|
subcutaneous administrations of efgartigimod PH20 SC given by prefilled syringe (PFS).
For participants aged 12 to <18 years with body weight ≤50 kg, the study drug will be administered by vial and syringe.
|
|
Экспериментальный: Part B (Double-blinded treatment period): Efgartigimod PH20 SC
Participants will receive efgartigimod PH20 SC for 24 weeks
|
subcutaneous administrations of efgartigimod PH20 SC given by prefilled syringe (PFS).
For participants aged 12 to <18 years with body weight ≤50 kg, the study drug will be administered by vial and syringe.
|
|
Плацебо Компаратор: Part B (Maintenance double-blinded treatment period): Placebo PH20 SC
Participants will receive placebo for 24 weeks
|
subcutaneous administrations of placebo PH20 SC given by prefilled syringe (PFS). For participants aged 12 to <18 years with body weight ≤50 kg, the study drug will be administered by vial and syringe |
|
Экспериментальный: Part C (Open-Label Extension Period): Efgartigimod PH20 SC
Participants who complete Part B will receive efgartigimod PH20 SC for 24 weeks
|
subcutaneous administrations of efgartigimod PH20 SC given by prefilled syringe (PFS).
For participants aged 12 to <18 years with body weight ≤50 kg, the study drug will be administered by vial and syringe.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in CASE score in the NMDAR population
Временное ограничение: up to week 24
|
CASE= Clinical Assessment Scale in Autoimmune Encephalitis; NMDAR=N-methyl-D-aspartate receptor; Neuropsychological Status.
The CASE (Clinical Assessment Scale in AIE) includes an assessment of 9 items: seizure, memory dysfunction, psychiatric symptoms, consciousness, language problems, dyskinesia/dystonia, gait instability and ataxia, brainstem dysfunction, weakness.
This overall CASE total score ranges from 0 to 27, with a higher score indicating a greater degree of disability.
|
up to week 24
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in mRS
Временное ограничение: up to week 8
|
The mRS (modified Rankin Scale) is commonly used to measure the degree of disability or dependence in the daily activities of people with neurological disabilities.
Scores range from 0 (no symptoms) to 6(dead).
|
up to week 8
|
|
Change in CASE score
Временное ограничение: up to week 8
|
The CASE (Clinical Assessment Scale in AIE) includes an assessment of 9 items: seizure, memory dysfunction, psychiatric symptoms, consciousness, language problems, dyskinesia/dystonia, gait instability and ataxia, brainstem dysfunction, weakness.
This overall CASE total score ranges from 0 to 27, with a higher score indicating a greater degree of disability.
|
up to week 8
|
|
Change in MoCA total score
Временное ограничение: up to week 8
|
MoCA= Montreal Cognitive Assessment
|
up to week 8
|
|
Change in NPI-C total score
Временное ограничение: up to week 8
|
The NPI-C (Neuropsychiatric Inventory--Clinician) total score will be used as a global measure of neuropsychiatric symptoms.Total score is calculated by summing the scores of all the individual domains.Each domain score is determined by summing the item scores within that domain.
The NPI-C uses a clinician rating method, where ratings for frequency, severity, and caregiver distress are provided for each item.These item scores are then summed to create a total domain score.
|
up to week 8
|
|
Change from baseline in CGI-S
Временное ограничение: up to week 8
|
Expression of Change. CGI is a clinician-rated scale that measures illness severity (CGI-S) and global improvement or change (CGI-C).It is rated on a 7-point scale, from 1 (normal) to 7 (amongst the most severely ill patients) for CGI-S and from 1 (very much improved) to 7 (very much worse) for CGI-C. PGI-S and PGI-C are the patient-reported counterparts to CGI-S and CGI-C, respectively. |
up to week 8
|
|
Change from baseline in PGI-S
Временное ограничение: up to week 8
|
A Impression of Severity; PGI-S= Patient Global Impression Scale.
PGI-S and PGI-C are the patient-reported counterparts to CGI-S and CGI-C, respectively.
|
up to week 8
|
|
Change from baseline in CGI-C
Временное ограничение: up to week 8
|
CGI-C= Clinical Global Expression of Change . CGI is a clinician-rated scale that measures illness severity (CGI-S) and global improvement or change (CGI-C).It is rated on a 7-point scale, from 1 (normal) to 7 (amongst the most severely ill patients) for CGI-S and from 1 (very much improved) to 7 (very much worse) for CGI-C. PGI-S and PGI-C are the patient-reported counterparts to CGI-S and CGI-C, respectively. |
up to week 8
|
|
Change from baseline in PGI-C
Временное ограничение: up to week 8
|
A Impression of Severity; PGI-C= Patient Global Expression of Change .
PGI-S and PGI-C are the patient-reported counterparts to CGI-S and CGI-C, respectively.
|
up to week 8
|
|
Incidence and severity of AEs
Временное ограничение: up to week 8
|
AEs= Adverse Effects
|
up to week 8
|
|
Incidence and severity of SAEs
Временное ограничение: up to week 8
|
SAEs = Serious Adverse Effects
|
up to week 8
|
|
Trough efgartigimod serum concentrations over time
Временное ограничение: up to week 8
|
up to week 8
|
|
|
Percent change from baseline in total IgG levels in serum over time
Временное ограничение: up to week 8
|
IgG= Immunoglobulin G
|
up to week 8
|
|
Incidence and prevalence of ADA against efgartigimod in serum over time
Временное ограничение: up to week 8
|
ADA = antidrug antibody(ies)
|
up to week 8
|
|
Incidence and prevalence of antibodies against rHuPH20 in plasma over time
Временное ограничение: up to week 8
|
rHuPH20 = Recombinant Human Hyaluronidase PH20
|
up to week 8
|
|
Change in mRS in the NMDAR population
Временное ограничение: up to week 24
|
The mRS (modified Rankin Scale) is commonly used to measure the degree of disability or dependence in the daily activities of people with neurological disabilities.
Scores range from 0 (no symptoms) to 6(dead)
|
up to week 24
|
|
Change in NPI-C total score in the NMDAR population
Временное ограничение: up to week 24
|
NPI-C=Neuropsychiatric Inventory-Clinician; NMDAR=N-methyl-D-aspartate receptor.
The NPI-C (Neuropsychiatric Inventory--Clinician) total score will be used as a global measure of neuropsychiatric symptoms.
Total score is calculated by summing the scores of all the individual domains.
Each domain score is determined by summing the item scores within that domain.
The NPI-C uses a clinician rating method, where ratings for frequency, severity, and caregiver distress are provided for each item.These item scores are then summed to create a total domain score.
|
up to week 24
|
|
Change in RBANS in the NMDAR population
Временное ограничение: up to week 24
|
RBANS=Repeatable Battery for the Assessment of Neuropsychological Status; NMDAR=N-methyl-D-aspartate receptor.
The RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) is a performance outcome measure developed to identify and characterize cognitive impairment by assessing an individual's current level of cognitive performance.
|
up to week 24
|
|
Percentage of CASE responders in the NMDAR population.
Временное ограничение: at week 24
|
CASE = Clinical Assessment Scale in AIE ; NMDAR=N-methyl-D-aspartate receptor
|
at week 24
|
|
Change in CASE score in the non-NMDAR population
Временное ограничение: up to week 24
|
CASE = Clinical Assessment Scale in AIE; NMDAR=N-methyl.
The CASE (Clinical Assessment Scale in AIE) includes an assessment of 9 items: seizure,memory dysfunction, psychiatric symptoms, consciousness, language problems, dyskinesia/dystonia, gait instability and ataxia, brainstem dysfunction, weakness.
This overall CASE total score ranges from 0 to 27, with a higher score indicating a greater degree of disability.
|
up to week 24
|
|
Change in RBANS in the non-NMDAR population
Временное ограничение: up to week 24
|
RBANS= Repeatable Battery for the Assessment of Neuropsychological Status; NMDAR=N-methyl-D-aspartate receptor.
The RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) is a performance outcome measure developed to identify and characterize cognitive impairment by assessing an individual's current level of cognitive performance.
|
up to week 24
|
|
Change in NPI-C total score in the non-NMDAR population
Временное ограничение: up to week 24
|
NPI-C= Neuropsychiatric Inventory-Clinician; NMDAR=N-methyl-D-aspartate receptor.
The NPI-C Neuropsychiatric Inventory--Clinician) total score will be used as a global measure of neuropsychiatric symptoms.
Total score is calculated by summing the scores of all the individual domains.
Each domain score is determined by summing the item scores within that domain.
The NPI-C uses a clinician rating method, where ratings for frequency, severity, and caregiver distress are provided for each item.
|
up to week 24
|
|
Change in mRS in the non-NMDAR population
Временное ограничение: up to week 24
|
mRS= modified Rankin Scale; NMDAR=N-methyl-D-aspartate receptor.
The mRS (modified Rankin Scale) is commonly used to measure the degree of disability or dependence in the daily activities of people with neurological disabilities.Scores range from 0 (no symptoms) to 6 (dead).
|
up to week 24
|
|
Percentage of CASE responders in the non-NMDAR population.
Временное ограничение: at week 24
|
CASE = Clinical Assessment Scale in AIE ; NMDAR=N-methyl-D-aspartate receptor.
The CASE (Clinical Assessment Scale in AIE) includes an assessment of 9 items: seizure, memory dysfunction, psychiatric symptoms, consciousness, language problems, dyskinesia/dystonia, gait instability and ataxia, brainstem dysfunction, weakness.
This overall CASE total score ranges from 0 to 27, with a higher score indicating a greater degree of disability.
|
at week 24
|
|
Incidence and severity of AEs
Временное ограничение: week 24 onwards
|
AEs = Adverse Effects
|
week 24 onwards
|
|
Incidence and severity of SAEs
Временное ограничение: week 24 onwards
|
SAEs = Serious Adverse Effects
|
week 24 onwards
|
|
Proportion of participants with presence of neuropsychiatric symptoms, defined by NPI-C total score of at least 1 point
Временное ограничение: at week 24
|
NPI-C= Neuropsychiatric Inventory-Clinician.
The NPI-C (Neuropsychiatric Inventory--Clinician) total score will be used as a global measure of neuropsychiatric symptoms.
Total score is calculated by summing the scores of all the individual domains.
Each domain score is determined by summing the item scores within that domain.
The NPI-C uses a clinician rating method, where ratings for frequency, severity, and caregiver distress are provided for each item.
|
at week 24
|
|
Change in MoCA total score
Временное ограничение: up to week 24
|
MoCA= Montreal Cognitive Assessment
|
up to week 24
|
|
Proportion of participants with a favorable outcome in mRS where favorable outcome is defined as no worsening for participants with a baseline mRS score of ≤2 or improvement of ≥1 point for participants with a baseline mRS score of >2
Временное ограничение: up to week 24
|
mRS=modified Rankin Scale.
The mRS (modified Rankin Scale) is commonly used to measure the degree of disability or dependence in the daily activities of people with neurological disabilities.
Scores range from 0 (no symptoms) to 6 (dead).
|
up to week 24
|
|
Change in CGI-S
Временное ограничение: up to week 24
|
CGI-S= Clinical Global Impression of Severity.
CGI is a clinician-rated scale that measures illness severity (CGI-S) and global improvement or change (CGI-C).It is rated on a 7-point scale, from 1 (normal) to 7 (amongst the most severely ill patients) for CGI-S and from 1 (very much improved) to 7 (very much worse) for CGI-C.
|
up to week 24
|
|
Change in CGI-C
Временное ограничение: up to week 24
|
CGI-C= Clinical Global Impression of Change.
CGI is a clinician-rated scale that measures illness severity (CGI-S) and global improvement or change (CGI-C).It is rated on a 7-point scale, from 1 (normal) to 7 (amongst the most severely ill patients) for CGI-S and from 1 (very much improved) to 7 (very much worse) for CGI-C.
|
up to week 24
|
|
Change in PGI-C
Временное ограничение: week 0 to week 24
|
PGI-C =Patient Global Expression of Change.
PGI-S and PGI-C are the patient-reported counterparts to CGI-S and CGI-C, respectively.
|
week 0 to week 24
|
|
Change in PGI-S
Временное ограничение: week 0 to week 24
|
PGI-S= Patient Global Expression of Severity.
PGI-S and PGI-C are the patient-reported counterparts to CGI-S and CGI-C, respectively.
|
week 0 to week 24
|
|
Time to resolution of status epilepticus
Временное ограничение: up to 24 weeks
|
up to 24 weeks
|
|
|
Time to first occurrence of seizure freedom.
Временное ограничение: up to 24 weeks
|
Seizure freedom is defined as no seizures for at least 28 consecutive days
|
up to 24 weeks
|
|
Proportion of participants with seizure freedom for at least the 28 consecutive days
Временное ограничение: up to 24 weeks
|
up to 24 weeks
|
|
|
Time to use of rescue therapy after randomization
Временное ограничение: up to 24 weeks
|
up to 24 weeks
|
|
|
Trough efgartigimod serum concentrations over time
Временное ограничение: up to 24 weeks
|
up to 24 weeks
|
|
|
Percent change in total IgG levels in serum
Временное ограничение: up to 24 weeks
|
IgG = Immunoglobulin G
|
up to 24 weeks
|
|
Incidence and prevalence of ADA against efgartigimod in serum over time
Временное ограничение: up to 24 weeks
|
ADA = anti drug antibodies
|
up to 24 weeks
|
|
Incidence and prevalence of antibodies against rHuPH20 in plasma over time
Временное ограничение: up to 24 weeks
|
rHuPH20 = Recombinant Human Hyaluronidase PH20
|
up to 24 weeks
|
|
Change in CASE score in the NMDAR population compared with the non-NMDAR population
Временное ограничение: up to 24 weeks
|
CASE = Clinical Assessment Scale in AIE ; NMDAR=N-methyl-D-aspartate receptor. .
The CASE (Clinical Assessment Scale in AIE) includes an assessment of 9 items: seizure, memory dysfunction, psychiatric symptoms, consciousness, language problems, dyskinesia/dystonia, gait instability and ataxia, brainstem dysfunction, weakness.
This overall CASE total score ranges from 0 to 27, with a higher score indicating a greater degree of disability.
|
up to 24 weeks
|
|
Change in RBANS total score
Временное ограничение: week 24 to week 48
|
The RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) is a performance outcome measure developed to identify and characterize cognitive impairment by assessing an individual's current level of cognitive performance.
|
week 24 to week 48
|
|
Percentage of participants with maintained change in the CASE total score (defined as stable or improving)
Временное ограничение: week 24 to week 48
|
The CASE (Clinical Assessment Scale in AIE) includes an assessment of 9 items: seizure, memory dysfunction, psychiatric symptoms, consciousness, language problems, dyskinesia/dystonia, gait instability and ataxia, brainstem dysfunction, weakness.
This overall CASE total score ranges from 0 to 27, with a higher score indicating a greater degree of disability.
|
week 24 to week 48
|
|
Percentage of participants with maintained mRS score (defined as stable or improving)
Временное ограничение: week 24 to week 48
|
The mRS (modified Rankin Scale) is commonly used to measure the degree of disability or dependence in the daily activities of people with neurological disabilities.
Scores range from 0 (no symptoms) to 6 (dead).
|
week 24 to week 48
|
|
Change in NPI-C total score
Временное ограничение: week 24 to week 48
|
The NPI-C (Neuropsychiatric Inventory--Clinician) total score will be used as a global measure of neuropsychiatric symptoms.Total score is calculated by summing the scores of all the individual domains.
Each domain score is determined by summing the item scores within that domain.
The NPI-C uses a clinician rating method, where ratings for frequency, severity, and caregiver distress are provided for each item.
These item scores are then summed to create a total domain score.
|
week 24 to week 48
|
|
Proportion of participants requiring rescue or second-line AIE therapies
Временное ограничение: week 24 to week 48
|
AIE = Auto-Immune Encephalitis
|
week 24 to week 48
|
|
Time to participants requiring rescue or second-line AIE therapies
Временное ограничение: week 24 to week 48
|
AIE = Auto-Immune Encephalitis
|
week 24 to week 48
|
|
Change in CASE
Временное ограничение: week 24 to week 48
|
The CASE (Clinical Assessment Scale in AIE) includes an assessment of 9 items: seizure, memory dysfunction, psychiatric symptoms, consciousness, language problems, dyskinesia/dystonia, gait instability and ataxia, brainstem dysfunction, weakness.
This overall CASE total score ranges from 0 to 27, with a higher score indicating a greater degree of disability.
|
week 24 to week 48
|
|
Change in mRs
Временное ограничение: week 24 to week 48
|
The mRS (modified Rankin Scale) is commonly used to measure the degree of disability or dependence in the daily activities of people with neurological disabilities.
Scores range from 0 (no symptoms) to 6 (dead).
|
week 24 to week 48
|
|
Change in RBANS
Временное ограничение: week 24 to week 48
|
The RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) is a performance outcome measure developed to identify and characterize cognitive impairment by assessing an individual's current level of cognitive performance.
|
week 24 to week 48
|
|
Time to resolution of status epilepticus
Временное ограничение: week 24 to week 48
|
week 24 to week 48
|
|
|
Proportion of participants with seizure freedom for at least the 28 consecutive days preceding the participants in final Part of trial
Временное ограничение: week 24 to week 48
|
mRS=modified Rankin Scale
|
week 24 to week 48
|
|
Incidence and prevalence of ADA against efgartigimod in serum
Временное ограничение: week 24 to week 48
|
ADA = antidrug antibody(ies)
|
week 24 to week 48
|
|
Percent change in total IgG levels in serum
Временное ограничение: week 24 to week 48
|
IgG = Immunoglobulin G
|
week 24 to week 48
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ARGX-113-22-AIE-2001
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Аутоиммунный энцефалит (AE)
-
University Hospital, ToulouseРекрутингАутоиммунный энцефалит (AE)Франция
-
Tongji HospitalNanjing Bioheng Biotech Co., Ltd.РекрутингХроническая воспалительная демиелинизирующая полинейропатия (ХВДП) | Рецидивирующий или рефрактерный рассеянный склероз (РС) | Миастения (MG) | Аутоиммунный энцефалит (AE)Китай
-
Tongji HospitalРекрутингРассеянный склероз (РС) | Хроническая воспалительная демиелинизирующая полинейропатия (ХВДП) | Расстройство спектра зрительного нервомиелита (NMOSD) | Миастения (MG) | Аутоиммунный энцефалит (AE) | Анти-миелин-олигодендроцитарный гликопротеин ассоциированное заболевание с иммуноглобулином G... и другие заболеванияКитай
Клинические исследования Efgartigimod PH20 (ARGX-113) SC
-
argenxЗавершенныйПервичная иммунная тромбоцитопенияСоединенные Штаты, Франция, Грузия, Германия, Италия, Япония, Польша, Российская Федерация, Испания, Турция, Соединенное Королевство, Аргентина, Австралия, Болгария, Чили, Китай, Дания, Греция, Ирландия, Израиль, Иордания, Корея, Республика и более
-
argenxАктивный, не рекрутирующийПервичная иммунная тромбоцитопенияГрузия, Япония, Польша, Соединенные Штаты, Аргентина, Австралия, Болгария, Чили, Китай, Ирландия, Италия, Иордания, Португалия, Румыния, Таиланд, Тунис, Греция, Мексика, Новая Зеландия, Норвегия, Южная Африка, Соединенное Королевство, Турция (Туркие) и более
-
argenxЗавершенный
-
argenxЗавершенныйЗдоровые волонтерыНидерланды
-
argenxАктивный, не рекрутирующийХроническая воспалительная демиелинизирующая полинейропатия (ХВДП)Соединенные Штаты, Австрия, Бельгия, Болгария, Китай, Чехия, Дания, Франция, Грузия, Германия, Израиль, Италия, Япония, Нидерланды, Польша, Российская Федерация, Сербия, Испания, Украина, Соединенное Королевство, Латвия, Румыния, Тай... и более
-
argenxЗавершенныйХроническая воспалительная демиелинизирующая полинейропатия (ХВДП)Соединенные Штаты, Австрия, Бельгия, Болгария, Китай, Чехия, Дания, Франция, Грузия, Германия, Венгрия, Израиль, Италия, Япония, Латвия, Нидерланды, Польша, Румыния, Российская Федерация, Сербия, Испания, Тайвань, Турция, Украина, Соединенное...
-
argenxЗавершенныйПервичная иммунная тромбоцитопенияСоединенные Штаты, Австрия, Бельгия, Болгария, Чехия, Франция, Грузия, Германия, Венгрия, Италия, Япония, Нидерланды, Польша, Испания, Соединенное Королевство, Украина, Россия, Турция (Туркие)
-
argenxПрекращеноЩитовидная болезнь глазСоединенные Штаты, Япония, Болгария, Польша, Китай, Франция, Соединенное Королевство, Испания, Грузия, Латвия, Италия, Сербия, Германия, Швейцария, Турция (Туркие), Австрия, Словения, Швеция
-
argenxАктивный, не рекрутирующийМиастения Гравис, глазнаяСоединенные Штаты, Испания, Соединенное Королевство, Бельгия, Дания, Китай, Япония, Германия, Чехия, Нидерланды, Канада, Австралия, Финляндия, Польша, Италия, Сербия, Франция, Швеция, Австрия, Грузия, Греция, Южная Корея, Португалия, Кипр и более
-
argenxЗавершенный