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Amyotrophic Lateral SclerosisPhase 2MIROCALSNCT03039673

MIROCALS: Modifying Immune Response and OutComes in ALS

A Phase 2 study testing Riluzole, IL-2 and 5% glucose water solution in people with Amyotrophic Lateral Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

MIROCALS is a phase II study of ld-IL-2 as a therapeutic agent for ALS. A randomized (1:1), placebo-controlled, double-blind, parallel group trial will be carried out to assess ld-IL-2 safety and clinical efficacy on survival and functional decline in newly diagnosed ALS patients treated for 18 months. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Amyotrophic Lateral Sclerosis
What is being tested?
Riluzole, IL-2 and 5% glucose water solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
304 participants
Where
17 sitesin 2 countries
Study dates
19 Jun 2017to 22 Jul 2021
Phase
Phase 2
Are there results?
None posted in the registry

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

France10 sites

  • CHRU de Lille - Hôpital Roger Salengro

    Lille, 59037

  • CHU de Limoges - Hôpital Dupuytren

    Limoges, 87042

  • HCL - Hôpital Neurologique P. Wertheimer

    Lyon, 69677

  • APHM - Hôpital de la Timone

    Marseille, 13385

  • CHRU de Montpellier - Hôpital Gui de Chauliac

    Montpellier, 34295

  • CHU de Nice - Hôpital Pasteur

    Nice, 06002

  • APHP - Groupe Hospitalier Pitié-Salpetrière

    Paris, 75651

  • CENTRE HOSPITALIER DE SAINT BRIEUC - Hôpital Yves Le Foll

    Saint-Brieuc, 22027

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098

  • CHRU de Tours - Hôpital Bretonneau

    Tours, 37044

Other trials in France

United Kingdom7 sites

  • Trafford Centre for Biomedical Research

    Brighton, BN1 9RY

  • Institute of Neurological Sciences, Queen Elizabeth University Hospital

    Glasgow, G514TF

  • North-East London and Essex MND Regional Care Centre

    London, E1 4NS

  • King's MND Care and Research Centre

    London, SE5 8AF

  • Centre for Neuromuscular Diseases - National Hospital of Neurology

    London, WC1N 3BG

  • Salford Royal NHS Foundation Trust, Neurology Dept

    Manchester, M6 8HD

  • Sheffield Care and Research Centre

    Sheffield, S10 2JF

Other trials in United Kingdom

About this study

Official title: Efficacy and Safety of Low-dose IL-2 (Ld-IL-2) as a Treg Enhancer for Controlling Neuro-inflammation in Newly Diagnosed Amyotrophic Lateral Sclerosis (ALS) Patients: A Randomized, Double-blind, Placebo- Controlled, Phase-II Proof of Concept/ Proof of Mechanism Clinical Trial

MIROCALS is a phase II study of ld-IL-2 as a therapeutic agent for ALS. A randomized (1:1), placebo-controlled, double-blind, parallel group trial will be carried out to assess ld-IL-2 safety and clinical efficacy on survival and functional decline in newly diagnosed ALS patients treated for 18 months. Randomization will be stratified according to (i) country (n = 2 levels: UK, France) and (ii) site of onset (n= 2 levels: bulbar vs limb onset).

The primary objective to evaluate the clinical efficacy and safety of the experimental drug (ld IL-2) over an 18 months period in order to establish the proof of concept (PoC) that modifying immune responses through the enhancement of regulatory T cells modifies the rate of ALS disease progression.

Read the detailed description

The secondary objectives of MIROCALS are:

To validate a new phase-II study design to improve the efficiency of drug development in ALS with early determination of drug response using established biomarkers (BMs).

The aims of this new trial design are:

(i) To shorten future trials duration in ALS using an early drug responding surrogate marker of disease activity; (ii) To establish the proof of mechanism (PoM) of the tested drugs; (iii) To identify drug responder status.

Additional exploratory objectives are:

(i) Deep immune \& inflammatory phenotyping (ii) Brain biomarkers (iii) Genomics and Transcriptomics

Being tested
Riluzole, IL-2, 5% glucose water solution
Keywords
interleukin-2, low-dose interleukin-2
Medical subject headings
Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RiluzoleDrug

    All patients will be treated with Riluzole for a period of three months prior to final inclusion and randomization. Riluzole treatment will continue throughout the 18 months of follow-up planned for in this protocol.

    Riluzole treatment is part of routine care for patients with ALS.

  • IL-2Drug

    Also called low dose interleukin-2, ultra low dose interleukin-2

    The dose of IL-2 to be used in this study will be 2.0 million IU/day.

    Each treatment course will last 5 days (i.e. 1 sub-cutaneous injection per day for 5 consecutive days). The 5-day course will be repeated every 4-weeks over an 18-month treatment period.

    In case of intolerance, a flexible dose-reduction schedule is available.

  • 5% glucose water solutionDrug

    The placebo consists of 5% glucose water solution, which is the matrix with which low-dose IL-2 injections are prepared in the experimental arm. Placebo injections are prepared in exactly the same manner as IL-2 injections, just without the IL-2.

    Each treatment course will last 5 days (i.e. 1 sub-cutaneous injection per day for 5 consecutive days). The 5-day course will be repeated every 4-weeks over an 18-month treatment period.

Study groups in NCT03039673
Study groupRoleWhat they receive
low dose interleukin-2ExperimentalPatients randomized to this arm will receive subcutaneous injections of low-dose interleukin-2 in addition to oral Riluzole treatment. Intervention: Riluzole Intervention: IL-2
Receives: Drug: Riluzole; Drug: IL-2
PlaceboPlacebo comparatorPatients randomized to this arm will receive subcutaneious placebo injections (5% glucose water solution) in addition to oral Riluzole treatment. Intervention: Riluzole Intervention: 5% glucose water solution
Receives: Drug: Riluzole; Drug: 5% glucose water solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to death from date of randomization to date of death

    Time to death from date of randomization to date of death as documented in death certificates, or date of last documented news for patients lost to follow-up, or 640 days for patients who survive more than 640 days (censoring at 640 days). Death certificates are collected by the centre's principal investigator from the City Hall of the patients' home or birth place.

    Measured: Month 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2017 (estimated)
  2. Study start19 Jun 2017
  3. Primary completion22 Jul 2021
  4. Study completion22 Jul 2021

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03039673
Sponsor's protocol ID
H2020/PHRC-N/2014/GB-01
Other IDs
2015-005347-14, 2015
Acronym
MIROCALS
Status last verified
Nov 2025
First submitted
31 Jan 2017
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Bensimon G, Leigh PN, Tree T, Malaspina A, Payan CA, Pham HP, Klaassen P, Shaw PJ, Al Khleifat A, Amador MDM, Attarian S, Bell SM, Beltran S, Bernard E, Camu W, Corcia P, Corvol JC, Couratier P, Danel V, Debs R, Desnuelle C, Dimitriou A, Ealing J, Esselin F, Fleury MC, Gorrie GH, Grapperon AM, Hesters A, Juntas-Morales R, Kolev I, Lautrette G, Le Forestier N, McDermott CJ, Pageot N, Salachas F, Sharma N, Soriani MH, Sreedharan J, Svahn J, Verber N, Verschueren A, Yildiz O, Suehs CM, Saker-Delye S, Muller C, Masseguin C, Hajduchova H, Kirby J, Garlanda C, Locati M, Zetterberg H, Asselain B, Al-Chalabi A; MIROCALS Study Group. Efficacy and safety of low-dose IL-2 as an add-on therapy to riluzole (MIROCALS): a phase 2b, double-blind, randomised, placebo-controlled trial. Lancet. 2025 May 24;405(10492):1837-1850. doi: 10.1016/S0140-6736(25)00262-4. Epub 2025 May 9.

    PubMed 40354799

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Riluzole, IL-2 and 5% glucose water solution in people with Amyotrophic Lateral Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France, United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to death from date of randomization to date of death (time frame: Month 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03039673, which also lists 1 linked publication.

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 4 Dec 2025.

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