Use of Low Doses of Interleukin-2 in Autism Spectrum Disorders

"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)."