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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT07589842

Run by

Assistance Publique - Hôpitaux de Paris

People needed

22

Starts

2026-10-01

Expected to finish

2029-08-01

Last updated by the study team

2026-05-15

Who can join

Age: 6 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Robert Debré Hospital — Paris, France

Full record on ClinicalTrials.gov

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