Autism Spectrum DisorderPhase 2ALaDINNCT07589842
Use of Low Doses of Interleukin-2 in Autism Spectrum Disorders
A Phase 2 study testing ILT-101 ld-(IL2) and NaCl (0,9%) in people with Autism Spectrum Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- ILT-101 ld-(IL2) and NaCl (0,9%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 1 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 :
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
"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)."
- Conditions
- Autism Spectrum Disorder
- Being tested
- ILT-101 ld-(IL2), NaCl (0,9%)
- Keywords
- Autism Spectrum Disorder, ASI, Pregnancy, Interleukin-2
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILT-101 ld-(IL2)Drug
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).
NaCl (0,9%)Drug
Placebo (NaCl 0,9%), subcutaneously. Same administration schedule as for ILT-101.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Administration of Interlukin-2 Receives: Drug: ILT-101 ld-(IL2) |
| Control | Placebo comparator | Administration of Placebo NaCl 0.9% Receives: Drug: NaCl (0,9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tregs (in % of CD4+ cells and absolute value) between baseline and Day 8, compared with ILT-101 and placebo.
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.
Measured: At Day 8
Secondary outcomes (9)
Score of Vineland II Adaptive Behavior Composite- Total Score
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.
Measured: at Day 0, Day 85, Day 169 and Day 275
Score of Brief Observation of Social
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;
Measured: at Day 0, Day 85, Day 169 and Day 275
Score of Social Responsiveness Scale - total score
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;
Measured: at Day 0, Day 85, Day 169 and Day 275
Score of Autism Diagnostic observation schedule-2
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;
Measured: at Day 0, Day 85, Day 169 and Day 275
Score of Repetitive behaviour and stereotypies: Aberrant Behavior Checklist
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;
Measured: at Day 0, Day 85, Day 169 and Day 275
Score of Global functional impact: Clinical Global Improvement
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;
Measured: at Day 0, Day 85, Day 169 and Day 275
Score of Global functional impact: Caregiver Strain Index
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;
Measured: at Day 0, Day 85, Day 169 and Day 275
Treg Th17 assays (in % of CD4+ and absolute value) and CD25
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
Measured: at Day 0, Day 8, Day 29, Day 85, Day 169 and Day 275
Score of Pediatric adverse event rating scale
Tolerance
Measured: at Day 0, Day 8, Day 29, Day 85, Day169 and Day 275
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Iltoo Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589842
- Sponsor's protocol ID
- APHP230867
- Other IDs
- 2025-522841-23-00, 2025
- Acronym
- ALaDIN
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Low Doses of Interleukin-2 in Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT07589842
- Acronym / sponsor ID
- ALaDIN / APHP230867
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, ASI, Pregnancy, Interleukin-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Iltoo Pharma
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"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)."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: ILT-101 ld-(IL2)Administration of Interlukin-2 |
| Control | Placebo comparator | Drug: NaCl (0,9%)Administration of Placebo NaCl 0.9% |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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 :
- Consent of parental authority and social security affiliation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | Experimental |
| NaCl (0,9%)Placebo (NaCl 0,9%), subcutaneously. Same administration schedule as for ILT-101. | Drug | Control |
Primary outcome
Change in Tregs (in % of CD4+ cells and absolute value) between baseline and Day 8, compared with ILT-101 and placebo.
Time frame: 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.
9 secondary outcomes
Score of Vineland II Adaptive Behavior Composite- Total Score
Time frame: at Day 0, Day 85, Day 169 and Day 275
Score of Brief Observation of Social
Time frame: at Day 0, Day 85, Day 169 and Day 275
Score of Social Responsiveness Scale - total score
Time frame: at Day 0, Day 85, Day 169 and Day 275
Score of Autism Diagnostic observation schedule-2
Time frame: at Day 0, Day 85, Day 169 and Day 275
Score of Repetitive behaviour and stereotypies: Aberrant Behavior Checklist
Time frame: at Day 0, Day 85, Day 169 and Day 275
Score of Global functional impact: Clinical Global Improvement
Time frame: at Day 0, Day 85, Day 169 and Day 275
Score of Global functional impact: Caregiver Strain Index
Time frame: at Day 0, Day 85, Day 169 and Day 275
Treg Th17 assays (in % of CD4+ and absolute value) and CD25
Time frame: at Day 0, Day 8, Day 29, Day 85, Day 169 and Day 275
Score of Pediatric adverse event rating scale
Time frame: at Day 0, Day 8, Day 29, Day 85, Day169 and Day 275
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ILT-101 ld-(IL2) and NaCl (0,9%) in people with Autism Spectrum Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre ELLUL, MD (0033140034131, pierre.ellul@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tregs (in % of CD4+ cells and absolute value) between baseline and Day 8, compared with ILT-101 and placebo. (time frame: At Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.