Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis

• Status: Completed
• Trial end date: 2020-06-15
• Target enrollment: 0
• Participant gender: All

Summary

Interleukin-2 (IL-2) was initially discovered and used as a stimulator of effector T lymphocytes (Teffs), but is now viewed as a very promising immunoregulatory drug having the capacity to stimulate regulatory T cells (Tregs). At low dose, Il-2 tips the Treg/Teff balance towards Tregs. Recently, it has been shown that Tregs of MS patients have reduced proliferative potential. MS-IL2 will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a Relapsing-Remitting Multiple Sclerosis (RRMS), with the aim to stimulate Treg and define potential clinical benefits

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Fondation ARSEP/AFM
• Treatments: Interleukin-2

Criteria

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