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

2026年5月13日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

"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)."

研究の種類

介入

入学 (推定)

22

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • フランス
      • Paris、フランス、75019
        • Robert Debre Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：Experimental
Administration of Interlukin-2
薬：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).
プラセボコンパレーター：Control
Administration of Placebo NaCl 0.9%
薬：NaCl (0,9%)
Placebo (NaCl 0,9%), subcutaneously. Same administration schedule as for ILT-101.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Tregs (in % of CD4+ cells and absolute value) between baseline and Day 8, compared with ILT-101 and placebo.
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Score of Vineland II Adaptive Behavior Composite- Total Score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Assistance Publique - Hôpitaux de Paris

協力者

Iltoo Pharma

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2028年11月30日

研究の完了 (推定)

2029年8月1日

試験登録日

最初に提出

2026年5月7日

QC基準を満たした最初の提出物

2026年5月13日

最初の投稿 (実際)

2026年5月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月15日

QC基準を満たした最後の更新が送信されました

2026年5月13日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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