ALDESLEUKIN for Autism spectrum disorder

Inclusion criteria

• {"criterion_text":"-Age 6 to 8 years\n-Severity of ASD considered moderate or severe on the ADOS\n-Meeting DSM-5 criteria for autism spectrum disorder\n-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\n-Consent of parental authority and social security affiliation\n-One of whose parents lives in the HAD pediatric intervention area"}

Exclusion criteria

• {"criterion_text":"-Recent change in ASD management (behavioral therapy within 6 weeks, introduction of psychotropic molecules within 2 weeks)\n-Contraindication to IL2 use (hypersensitivity, cancer history, active infection, obesity, transplant history, vaccination with live attenuated vaccine within 4 weeks)\n-Participation in another therapeutic trial within the last 3 months\n-BMI >95th percentile or BMI <5th percentile\n-Participants who have already received a genetic diagnosis of ASD of the ‘syndromic’ type by DNA chip chromosome analysis\n-Participants with hyperchloremia or hypernatremia\n-Participants who are related to a person involved in the study at the investigating centre, the clinical research organisation (CRO) or the sponsor.\n-Participant with uncontrolled epilepsy."}

Primary endpoints

• {"endpoint_text":"-Change in Tregs (in % of CD4+ cells and absolute value) between baseline and D8, compared with ILT-101 and placebo.","definition_or_measurement_approach":"Tregs measured as percentage of CD4+ cells and absolute value between baseline (D0) and Day 8 (D8); comparison between ILT-101 and placebo groups."}

Secondary endpoints

• {"endpoint_text":"-Clinical:\n-Socio-adaptive symptoms : Vineland II Adaptive Behavior Composite- Total Score [at D0, D85, D169 and D275].\n-Social Cognition: Vineland II Adaptive Behavior Composite- Score Socialization Domain [at D0, D85, D169 and D275].\n-Communication: Vineland II Adaptive Behavior Composite - Communication Domain Score [at D0, D85, D169 and D275].\n-Global functional impact: Vineland Adaptive Behavior Composite - Daily Life Domain Score [at D0, D85, D169 and D275].\n-Social Communication: Brief Observation of Social - Communication Change (BOSCC) [at D0, D85, D169 and D275] Social Cognition\n-Social cognition: Social Responsiveness Scale - total score [at D0, D85, D169 and D275].\n-Social cognition: Autism Diagnostic observation schedule-2 [at D0, 169 and D275].\n-Repetitive behaviour and stereotypies: Aberrant Behavior Checklist [at D0, D85, D169 and D275].\n-Hyperactivity: ADHD Rating Scale parent report- total score [at D0, 85, 169 and D275].\n-Global functional impact: Clinical Global Improvement - [at D0, D85, D169 and D275].\n-Global functional impact: Caregiver Strain Index - [at D0, D85, D169 and D275]\n-Biological:\n-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)\n-Tolerance:\n-Pediatric adverse event rating scale [at D0, D8, D85, D169]","definition_or_measurement_approach":"Clinical endpoints measured by standard instruments and at specified timepoints: Vineland II Adaptive Behavior Composite (total and domain scores) at D0, D85, D169, D275; BOSCC at D0, D85, D169, D275; Social Responsiveness Scale at D0, D85, D169, D275; ADOS-2 at D0, D169, D275; Aberrant Behavior Checklist and ADHD Rating Scale at listed timepoints. Biological endpoints: Treg, Th17 and CD25 assays (% of CD4+ and absolute value) at specified days and AUC calculations (D0-D29 / D29-169). Tolerance assessed via Pediatric adverse event rating scale at listed timepoints."}

France

Earliest CTIS Part Ii Submission Date

30-09-2025

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

218

Number Of Sites

3

Number Of Participants

22

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"DGOS - Ministry of Health","duties_or_roles":"Monetary support","organisation_type":""}