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Use of low doses of interleukin-2 in autism spectrum disorders
EU CTIS ID: 2025-522841-23-00
What this study is testing
To evaluate the stimulation of the Tregs of 6 to 8 -year-old children with ASD whose mothers had ASI during pregnancy, by low doses of interleukin-2 (ILT-101) on day 8 versus placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 6 to 8 years
- Severity of ASD considered moderate or severe on the ADOS
- Meeting DSM-5 criteria for autism spectrum disorder
- 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 likely can't join 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
See the full eligibility criteria
- Age 6 to 8 years
- Severity of ASD considered moderate or severe on the ADOS
- Meeting DSM-5 criteria for autism spectrum disorder
- 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
- 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
- Participants who are related to a person involved in the study at the investigating centre, the clinical research organisation (CRO) or the sponsor.
- Participant with uncontrolled epilepsy.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.