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Can a Low-Dose immune booster tame ALS inflammation?

NCT ID NCT03039673

Disease control Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested whether low-dose interleukin-2 (IL-2) can help control nerve inflammation in people newly diagnosed with ALS. Over 18 months, 304 participants received either IL-2 or a placebo, alongside standard riluzole treatment. The goal was to see if boosting regulatory T cells could slow the disease and improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
low-dose interleukin-2 (IL-2)
What this could lead to
If it works, this could point toward a treatment that slows ALS progression and extends survival by calming nerve inflammation.
What could go wrong
This is a mid-stage trial with 304 participants, so results may not be conclusive. ALS is complex, and boosting immune cells might not slow the disease in all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

304 people

The number who actually took part.

Started

Jun 2017

Finished

Jul 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion criteria * Patient is 18 years old and less than 76 years old * Possible, Probable, Probable laboratory-supported or Definite ALS as defined by El Escorial Revised ALS diagnostic criteria * Disease duration \<= 24 months * Slow Vital capacity \>= 70% of normal * No prior or present riluzole treatment * Lumbar punctures accepted by patient and done Main Exclusion criteria * Other neurodegenerative disease that could explain signs or symptoms * Contra indication for lumbar puncture (history of allergy to xylocaine, presence of contra-indicated treatment, or coagulation test abnormality, clinically significant coagulopathy or thrombocytopenia) * Non authorized treatment * Other disease or disorders that could preclude functional assessment, or life-threatening disorders * Any documented, active, past or present, auto-immune disorders except asymptomatic Hashimoto thyroiditis * Using assisted ventilation * Feeding through gastrostomy or nasogastric tube * Women of child-bearing potential or sexually active man without contraception * Pregnant or breast feeding woman * Any clinically significant laboratory abnormality (excepting cholesterol, triglyceride, glucose, CK, ferritin) * History of documented symptomatic and treated asthma within the past 5 years

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis

Contacts and locations

Locations

  • APHM - Hôpital de la Timone

    Marseille, 13385, France

  • APHP - Groupe Hospitalier Pitié-Salpetrière

    Paris, 75651, France

  • CENTRE HOSPITALIER DE SAINT BRIEUC - Hôpital Yves Le Foll

    Saint-Brieuc, 22027, France

  • CHRU de Lille - Hôpital Roger Salengro

    Lille, 59037, France

  • CHRU de Montpellier - Hôpital Gui de Chauliac

    Montpellier, 34295, France

  • CHRU de Tours - Hôpital Bretonneau

    Tours, 37044, France

  • CHU de Limoges - Hôpital Dupuytren

    Limoges, 87042, France

  • CHU de Nice - Hôpital Pasteur

    Nice, 06002, France

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098, France

  • Centre for Neuromuscular Diseases - National Hospital of Neurology

    London, WC1N 3BG, United Kingdom

  • HCL - Hôpital Neurologique P. Wertheimer

    Lyon, 69677, France

  • Institute of Neurological Sciences, Queen Elizabeth University Hospital

    Glasgow, G514TF, United Kingdom

  • King's MND Care and Research Centre

    London, SE5 8AF, United Kingdom

  • North-East London and Essex MND Regional Care Centre

    London, E1 4NS, United Kingdom

  • Salford Royal NHS Foundation Trust, Neurology Dept

    Manchester, M6 8HD, United Kingdom

  • Sheffield Care and Research Centre

    Sheffield, S10 2JF, United Kingdom

  • Trafford Centre for Biomedical Research

    Brighton, BN1 9RY, United Kingdom

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