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Use of Low Doses of Interleukin-2 in Autism Spectrum Disorders (ALaDIN)

13 mai 2026 mis à jour par: Assistance Publique - Hôpitaux de Paris
Autism spectrum disorders (ASD) are neurodevelopmental disorders that affect around 1% of the population. Matenral immune activation (MIA) during pregnancy is a risk factor for ASD in children (Han 2021), mediated by maternal secretion of IL-17a, which disrupts neurodevelopment (Choi 2016). MIA causes a long-lasting disruption of the Tregs/Th17 balance in offspring (decrease in anti-inflammatory Tregs/increase in pro-inflammatory Th17s) via epigenetic mechanisms (Lim 2021; Ellul 2021). In a mouse model of MIA, adoptive transfer of Tregs was able to normalise autistic behaviour, highlighting the importance of Tregs in maintaining the autistic phenotype (Xu, 2021). In this same model, we have shown that IL-2fd (i) stimulates Tregs, (ii) corrects meningeal inflammation (iii) normalises synaptic connectivity and (iv) normalises autistic behaviour in the offspring (Ellul 2025). In humans, the use of low doses of interleukin-2 (IL2-fd) (ILT-101) leads to activation and selective expansion of Tregs and a reduction in Th17 (Klatzmann 2015), including in children (Rosenzwajg 2020). We hypothesise that the use of IL2-fd (ILT-101) in ASD patients born to mothers with a history of MIA could correct the Tregs deficiency and improve autistic symptoms.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

"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)."

Type d'étude

Interventionnel

Inscription (Estimé)

22

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • France
      • Paris, France, 75019
        • Robert Debre Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Experimental
Administration of Interlukin-2
Médicament: ILT-101 ld-(IL2)
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).
Comparateur placebo: Control
Administration of Placebo NaCl 0.9%
Médicament: NaCl (0,9%)
Placebo (NaCl 0,9%), subcutaneously. Same administration schedule as for ILT-101.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Tregs (in % of CD4+ cells and absolute value) between baseline and Day 8, compared with ILT-101 and placebo.
Délai: At Day 8
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.
At Day 8

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Score of Vineland II Adaptive Behavior Composite- Total Score
Délai: at Day 0, Day 85, Day 169 and Day 275
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.
at Day 0, Day 85, Day 169 and Day 275
Score of Brief Observation of Social
Délai: 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;
at Day 0, Day 85, Day 169 and Day 275
Score of Social Responsiveness Scale - total score
Délai: 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;
at Day 0, Day 85, Day 169 and Day 275
Score of Autism Diagnostic observation schedule-2
Délai: 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;
at Day 0, Day 85, Day 169 and Day 275
Score of Repetitive behaviour and stereotypies: Aberrant Behavior Checklist
Délai: 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;
at Day 0, Day 85, Day 169 and Day 275
Score of Global functional impact: Clinical Global Improvement
Délai: 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;
at Day 0, Day 85, Day 169 and Day 275
Score of Global functional impact: Caregiver Strain Index
Délai: 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;
at Day 0, Day 85, Day 169 and Day 275
Treg Th17 assays (in % of CD4+ and absolute value) and CD25
Délai: at Day 0, Day 8, Day 29, Day 85, Day 169 and Day 275
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
at Day 0, Day 8, Day 29, Day 85, Day 169 and Day 275
Score of Pediatric adverse event rating scale
Délai: at Day 0, Day 8, Day 29, Day 85, Day169 and Day 275
Tolerance
at Day 0, Day 8, Day 29, Day 85, Day169 and Day 275

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Assistance Publique - Hôpitaux de Paris

Collaborateurs

Iltoo Pharma

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

30 novembre 2028

Achèvement de l'étude (Estimé)

1 août 2029

Dates d'inscription aux études

Première soumission

7 mai 2026

Première soumission répondant aux critères de contrôle qualité

13 mai 2026

Première publication (Réel)

15 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • APHP230867
  • 2025-522841-23-00 (Ctis)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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