MIROCALS: Modifying Immune Response and OutComes in ALS
NCT ID: NCT03039673
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
304 participants
INTERVENTIONAL
2017-06-19
2021-07-22
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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low dose interleukin-2
Patients randomized to this arm will receive subcutaneous injections of low-dose interleukin-2 in addition to oral Riluzole treatment.
Intervention: Riluzole Intervention: IL-2
Riluzole
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-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.
Placebo
Patients 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
Riluzole
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.
5% glucose water solution
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.
Interventions
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Riluzole
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-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 solution
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Nigel Leigh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Brighton and Sussex Medical School
Gilbert Bensimon, MD, PhD
Role: STUDY_DIRECTOR
Centre Hospitalier Universitaire de Nîmes
Locations
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CHRU de Lille - Hôpital Roger Salengro
Lille, , France
CHU de Limoges - Hôpital Dupuytren
Limoges, , France
HCL - Hôpital Neurologique P. Wertheimer
Lyon, , France
APHM - Hôpital de la Timone
Marseille, , France
CHRU de Montpellier - Hôpital Gui de Chauliac
Montpellier, , France
CHU de Nice - Hôpital Pasteur
Nice, , France
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, , France
CENTRE HOSPITALIER DE SAINT BRIEUC - Hôpital Yves Le Foll
Saint-Brieuc, , France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, , France
CHRU de Tours - Hôpital Bretonneau
Tours, , France
Trafford Centre for Biomedical Research
Brighton, , United Kingdom
Institute of Neurological Sciences, Queen Elizabeth University Hospital
Glasgow, , United Kingdom
North-East London and Essex MND Regional Care Centre
London, , United Kingdom
King's MND Care and Research Centre
London, , United Kingdom
Centre for Neuromuscular Diseases - National Hospital of Neurology
London, , United Kingdom
Salford Royal NHS Foundation Trust, Neurology Dept
Manchester, , United Kingdom
Sheffield Care and Research Centre
Sheffield, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2015-005347-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
H2020/PHRC-N/2014/GB-01
Identifier Type: -
Identifier Source: org_study_id
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