AuthorisedTherapeutic exploratory (Phase II)Interventional

ALaDIN - Use of low doses of interleukin-2 in autism spectrum disorders

The ALaDIN study is investigating a new treatment, ILT-101, for individuals with autism spectrum disorder (ASD). This Phase II trial is designed to test if small doses of ILT-101 can affect specific immune cells, called Tregs. Researchers will compare the effects of ILT-101 to a placebo (a dummy medicine) by measuring changes in these cells early on. They will also observe if there are any improvements in everyday skills, social interaction, communication, and behaviour over a longer period, such as how someone manages daily tasks or interacts with others. The study will also track any side effects to make sure the treatment is safe.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

17 Nov 2025

Autism Spectrum disorder ASD

What is this study about?

This study, called ALaDIN, is trying to understand if a new medicine, ILT-101, could be helpful for people with autism spectrum disorder (ASD). In ASD, the body's immune system might sometimes work differently, and this study focuses on a specific type of immune cell called Tregs.

The main aim is to see if taking low doses of ILT-101 changes the number of these Tregs in the blood shortly after starting the treatment. They will compare people who receive ILT-101 with those who get a placebo (a substance that looks like the medicine but has no active ingredients). This helps researchers see if any changes are truly due to the medicine. The study is also looking at safety, watching out for any side effects people might have.

Beyond just looking at cells, the study also wants to know if any changes in these Tregs are connected to improvements in daily life for people with ASD. Researchers will collect information over several months about things like social skills, communication, how well someone adapts to different situations, and any repetitive behaviours. This will help them understand if ILT-101 has a positive impact on a person's life and overall well-being.

Key takeaways

This study is testing a new medicine (ILT-101) for autism.
It aims to see how the medicine affects immune cells and daily life skills.
Participants will receive either the medicine or a placebo.
The study involves clinic visits, blood tests, and surveys over about 9 months.
You can stop participating at any time.
It's a Phase II study, meaning it's still in early stages of testing for effectiveness and safety.

Who may be eligible?

This study is open to both adults and children, regardless of their gender, who have been diagnosed with autism spectrum disorder. There are no specific age limits mentioned, meaning a wide range of ages may be considered.

To find out if you or a loved one might be able to join, you would need to speak with the study team. They will have a full list of specific health requirements and other details to check if the study is a good fit.

Usually, studies like this look for participants whose overall health is stable, and who are able to attend regular appointments and follow the study's instructions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a diagnosis of autism spectrum disorder?
Am I able to attend regular clinic appointments for about 9 months?
Am I generally in good health, aside from autism?
Am I comfortable with regular blood tests and questionnaires?
Am I based in the UK and able to travel to a study site?

Answer every question to see your result.

What does participation involve?

If you join this study, it would involve several visits to the clinic over roughly nine months. During these visits, you would receive either the study medicine (ILT-101 liquid) or a placebo, which looks the same but contains no active ingredient. You wouldn't know which one you are taking.

Researchers will regularly collect blood samples to measure the immune cells and check how the treatment might be affecting your body. You'll also complete questionnaires and possibly have observations done at different times throughout the study period. These assessments will look at things like your social skills, communication, and daily living abilities. The total duration of the study, from your first visit to the last follow-up, would be about 275 days, which is just over 9 months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit if ILT-101 helps improve your immune system and leads to better social skills, communication, or daily living, or it might not have any effect. We don't yet know if ILT-101 is effective or what side effects it might have, as this is a new treatment being tested. There's a chance of experiencing side effects from the medication or discomfort from blood tests and other assessments. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is ILT-101?

ILT-101 is a new medicine being tested to see how it affects certain immune cells in people with autism.

What is a placebo?

A placebo looks like the study medicine but doesn't have any active ingredients. It helps researchers see if the real medicine is actually working.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know until the study is over.

How long will I be in the study?

Participation will last for about 9 months, with several visits to the clinic during that time.

What kind of tests will I have?

You will have blood tests and complete questionnaires about your social skills, communication, and daily life.