2025-522841-23-00尚未招募2 期
ALaDIN - Use of low doses of interleukin-2 in autism spectrum disorders
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Tregs (in % of CD4+ cells and absolute value) between baseline and D8, compared with ILT-101 and placebo.
研究概览
简要总结
To evaluate the stimulation of the Tregs of 4- to 6-year-old children with ASD whose mothers had ASI during pregnancy, by low doses of interleukin-2 (ILT-101) on day 8 versus placebo.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 4 to 6 years
- •Over 31 months: Severity of ASD considered moderate or severe
- •Meeting DSM-5 criteria for autism spectrum disorder
- •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
排除标准
- •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
- •Participants who are related to a person involved in the study at the investigating centre, the clinical research organisation (CRO) or the sponsor.
- •Participant with uncontrolled epilepsy.
结局指标
主要结局
Change in Tregs (in % of CD4+ cells and absolute value) between baseline and D8, compared with ILT-101 and placebo.
Change in Tregs (in % of CD4+ cells and absolute value) between baseline and D8, compared with ILT-101 and placebo.
次要结局
- Clinical:
- Socio-adaptive symptoms : Vineland II Adaptive Behavior Composite- Total Score [at D0, D85, D169 and D275].
- Social Cognition: Vineland II Adaptive Behavior Composite- Score Socialization Domain [at D0, D85, D169 and D275].
- Communication: Vineland II Adaptive Behavior Composite - Communication Domain Score [at D0, D85, D169 and D275].
- Global functional impact: Vineland Adaptive Behavior Composite - Daily Life Domain Score [at D0, D85, D169 and D275].
- Social Communication: Brief Observation of Social - Communication Change (BOSCC) [at D0, D85, D169 and D275] Social Cognition
- Social cognition: Social Responsiveness Scale - total score [at D0, D85, D169 and D275].
- Social cognition: Autism Diagnostic observation schedule-2 [at D0, 169 and D275].
- Repetitive behaviour and stereotypies: Aberrant Behavior Checklist [at D0, D85, D169 and D275].
- Hyperactivity: ADHD Rating Scale parent report- total score [at D0, 85, 169 and D275].
- Global functional impact: Clinical Global Improvement - [at D0, D85, D169 and D275].
- Global functional impact: Caregiver Strain Index - [at D0, D85, D169 and D275]
- Biological:
- Treg and Th17 assays (in % of CD4+ and absolute value) [at D0, D8, D29, D85, 169 and D275], and AUC (D0-D29 / D29-169)
- Tolerance:
- Pediatric adverse event rating scale [at D0, D8, D85, D169]
研究者
Dr. Pierre ELLUL
Scientific
Assistance Publique Hopitaux De Paris
研究点 (1)
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