Use of Low Doses of Interleukin-2 in Autism Spectrum Disorders (ALaDIN)
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
"A - Information and Inclusion: Patient identification and the proposal to participate in the research protocol will take place in the various screening units of the Child and Adolescent Psychiatry Department at Robert Debré Hospital, conducted by a child psychiatrist.
Inclusion and consent form signing will take place at the CIC (Clinical Investigation Center of Robert Debré Hospital) during the initial visit.
B - Patient follow-up during the trial:
Initial visit - The initial visit will take place at the CIC of Robert Debré Hospital. Randomization will then be carried out under the responsibility of the Robert Debré URC.
Follow-up visits - Subsequent visits for treatment administration will take place at the CIC. During these visits, patients will be assessed for clinical efficacy (Day 85, Day 169, Day 275) as well as safety/tolerance (Day 0, Day 8, Day 85, Day 169). They will also undergo biological sampling (Treg and Th17) on Day 0, Day 8, Day 29, and Days 85, 169, and 275.
C - End of study at Day 275.
Product presentation and origin:
ILT-101 will be provided free of charge by ILTOO Pharma, and the placebo will be prepared and supplied by AGEPS; both will be packaged in a double-blind manner. The administration schedule will be the same for ILT-101 and the placebo up to Day 169.
On Day 1, Day 29, Day 85, and Day 169, administration of the investigational treatment will take place at the CIC. From Day 2 to Day 5, Day 30 to Day 33, Day 57 to Day 61, Day 84 to Day 89, Day 113 to Day 117, Day 141 to Day 145, and Day 170 to Day 173, injections of ILT-101/placebo will be administered at the patients' homes by nurses from the Hospital-at-Home Department (AP-HP home hospitalization service)."
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Контакты и местонахождение
Контакты исследования
- Имя: Pierre ELLUL, MD
- Номер телефона: 0033140034131
- Электронная почта: pierre.ellul@aphp.fr
Места учебы
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Paris, Франция, 75019
- Robert Debre Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age 6 to 8 years
- Meeting DSM-5 criteria for autism spectrum disorder
- ASD severity classified as moderate or severe on the ADOS
Mother with :
(i) an autoimmune disease (as listed by the American Autoimmune Related Diseases Association: https://www.aarda.org/diseaselist/) that began during the first and second trimesters of pregnancy, or that was present prior to pregnancy and experienced a relapse (defined as a change in disease activity leading to a change/modification of treatment) during pregnancy; (ii) a maternal infection (viral or bacterial) during pregnancy, defined as a fever greater than 38.5°C for at least 48 hours and documented (medical consultation, biological sample, prescription of antipyretic and/or antibiotic). Infections by a pathogen with a well-documented direct cerebral effect (CMV) will be excluded.
- Consent of parental authority and social security affiliation
- One of whose parents lives in the HAD pediatric intervention area.
Exclusion Criteria:
- Recent change in ASD management (behavioral therapy within 6 weeks, introduction of psychotropic molecules within 2 weeks)
- Contraindication to IL2 use (hypersensitivity, cancer history, active infection, obesity, transplant history, vaccination with live attenuated vaccine within 4 weeks)
- Participation in another therapeutic trial within the last 3 months
- BMI >95th percentile or BMI <5th percentile
- Participants who have already received a genetic diagnosis of ASD of the 'syndromic' type by DNA chip chromosome analysis
- Participants with hyperchloremia or hypernatremia
- Participant with uncontrolled epilepsy.
- Participants who are related to a person involved in the study at the investigating centre, the clinical research organisation (CRO) or the sponsor.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Experimental
Administration of Interlukin-2
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ILT-101 (0.8 MUI/m²/day) subcutaneously.
Daily administration for 5 consecutive days (D1 to D5) every 4 weeks for 6 months (i.e. 7 courses of 5 days each).
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Плацебо Компаратор: Control
Administration of Placebo NaCl 0.9%
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Placebo (NaCl 0,9%), subcutaneously.
Same administration schedule as for ILT-101.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Tregs (in % of CD4+ cells and absolute value) between baseline and Day 8, compared with ILT-101 and placebo.
Временное ограничение: At Day 8
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To evaluate the stimulation of the Tregs of 6 to 8-years-old children with ASD whose mothers had MIA during pregnancy, by low doses of interleukin-2 (ILT-101) on day 8 versus placebo.
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At Day 8
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Score of Vineland II Adaptive Behavior Composite- Total Score
Временное ограничение: at Day 0, Day 85, Day 169 and Day 275
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To assess the effect at Day 85 and Day169 of low doses of interleukin-2 (ILT-101) versus placebo on the Vineland II global score and the persistent effect at Day 275.
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at Day 0, Day 85, Day 169 and Day 275
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Score of Brief Observation of Social
Временное ограничение: at Day 0, Day 85, Day 169 and Day 275
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Effect at Day 85 and Day 169 of ILT-101 versus placebo on the patient's other clinical dimensions (social cognition, repetitive behaviour and stereotypies, hyperactivity) and the residual effect at Day 275;
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at Day 0, Day 85, Day 169 and Day 275
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Score of Social Responsiveness Scale - total score
Временное ограничение: at Day 0, Day 85, Day 169 and Day 275
|
Effect at Day 85 and Day 169 of ILT-101 versus placebo on the patient's other clinical dimensions (social cognition, repetitive behaviour and stereotypies, hyperactivity) and the residual effect at Day 275;
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at Day 0, Day 85, Day 169 and Day 275
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Score of Autism Diagnostic observation schedule-2
Временное ограничение: at Day 0, Day 85, Day 169 and Day 275
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Effect at Day 85 and Day 169 of ILT-101 versus placebo on the patient's other clinical dimensions (social cognition, repetitive behaviour and stereotypies, hyperactivity) and the residual effect at Day 275;
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at Day 0, Day 85, Day 169 and Day 275
|
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Score of Repetitive behaviour and stereotypies: Aberrant Behavior Checklist
Временное ограничение: at Day 0, Day 85, Day 169 and Day 275
|
Effect at Day 85 and Day 169 of ILT-101 versus placebo on the patient's other clinical dimensions (social cognition, repetitive behaviour and stereotypies, hyperactivity) and the residual effect at Day 275;
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at Day 0, Day 85, Day 169 and Day 275
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Score of Global functional impact: Clinical Global Improvement
Временное ограничение: at Day 0, Day 85, Day 169 and Day 275
|
Effect at Day 85 and Day 169 of ILT-101 versus placebo on the patient's other clinical dimensions (social cognition, repetitive behaviour and stereotypies, hyperactivity) and the residual effect at Day 275;
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at Day 0, Day 85, Day 169 and Day 275
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Score of Global functional impact: Caregiver Strain Index
Временное ограничение: at Day 0, Day 85, Day 169 and Day 275
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Effect at Day 85 and Day 169 of ILT-101 versus placebo on the patient's other clinical dimensions (social cognition, repetitive behaviour and stereotypies, hyperactivity) and the residual effect at Day 275;
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at Day 0, Day 85, Day 169 and Day 275
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Treg Th17 assays (in % of CD4+ and absolute value) and CD25
Временное ограничение: at Day 0, Day 8, Day 29, Day 85, Day 169 and Day 275
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Measurement of Tregs, Th17 and CD25 at Day 0, Day 8, Day 29 then at , Day 8 and Day 169 and the residual effect at Day 275; as well as the correlation between the biological response and socio-communicative symptoms at Day 85 and Day 169 and the residual effect at Day 275
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at Day 0, Day 8, Day 29, Day 85, Day 169 and Day 275
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Score of Pediatric adverse event rating scale
Временное ограничение: at Day 0, Day 8, Day 29, Day 85, Day169 and Day 275
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Tolerance
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at Day 0, Day 8, Day 29, Day 85, Day169 and Day 275
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Соавторы и исследователи
Соавторы
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
- APHP230867
- 2025-522841-23-00 (Ктис)
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.
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