Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis (MS-IL2)

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Interleukin 2, IL2, Relapsing Remitting Multiple Sclerosis, Autoimmune diseases, Regulatory T cells, Tregs Read More

Inclusion Criteria:

• Age 18-65 years old ;
• Male and Female;
• Presenting relapsing remitting multiple sclerosis as determined by revised McDonald criteria (2010) ;
• On MRI : 1) Presenting 1-2 lesions enhanced by gadolinium (Gd+) (T1) without clinical expression of the disease clinique upon inclusion or 6 months prior to inclusion or 2) presenting one new lesion T2
• Expanded Disability Status Scale (EDSS) score comprised between 0 and 6;
• No flare (with or without any corticosteroid therapy) for the past 2 months
• Under β-Interferon treatment for ≥ 6 months ; or any other first-line treatment of the Relapsing-Remitting Multiple Sclerosis (RRMS): Dimethyl fumarate or teriflunomide treatment for ≥ 6 months or glatiramer acetate for ≥ 9 months
• For women of childbearing age, contraception for more than 2 weeks upon confirmation of inclusion criteria and negative Beta HCG on inclusion visit (D-30 to D-7);
• Patient informed consent should be signed by the patient and investigator before performing any clinical examination required for the study.
• Affiliation to the French Social Security Regimen

Exclusion Criteria:

• Number of lesions enhanced by gadolinium (Gd+) on MRI in T1 > 2 upon inclusion;

• Known intolerance to IL2 (see SPC):

  • Hypersensibility to active substance or one of the excipients ;
  • Signs of evolving infection requiring treatment
  • Other clinically significant chronic disorders (beside RR-MS)
  • History of organ allograft
• Administration of a non-authorized treatment; bolus of corticosteroids in the last 2 months, or treatment with cyclophosphamide, mitoxantrone, or rituximab in the last 6 months;
• Heart failure (≥ grade III NYHA), renal insufficiency, or hepatic insufficiency (transaminase>5N), or lung failure
• White blood cell count <3000 /mm3, lymphocytes< 1000 /mm3, platelets <150 000 /mm3
• Poor venous access not allowing repeated blood tests
• Vaccination with live attenuated virus in the months preceding the inclusion or planned during the study
• Surgery with general anaesthesia during the last 2 months or surgery planned during the study
• Participation in other biomedical research in the last one month or planned during the study
• Concomitant psychiatric disease or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give informed consent
• Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or basocellular carcinoma)
• Pregnant or lactating women;
• Men and women of childbearing potential without effective contraception for the duration of treatment
• Patients under a measure of legal protection