ALaDIN - Use of low doses of interleukin-2 in autism spectrum disorders

Condition studied

Autism Spectrum disorder ASD

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change in Tregs (in % of CD4+ cells and absolute value) between baseline and D8, compared with ILT-101 and placebo.

Endpoint detail

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, Th17 and CD25 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]