The primary objective is to evaluate the regulatory T cell response in Amyotrophic Lateral Sclerosis (ALS) patients to three low-dose interleukin-2 (ld-IL-2) posologies (0.5, 1 and 2 MIU per day for 5 consecutive days and the beginning of three consecutive months).
The secondary objective of this study is to evaluate the acute and short-term safety and tolerability of this therapy. Co-occuring functional changes will also be described, as well as effects on T-cells and pNFH serum levels for exploratory purposes. This is a phase II study on ld-IL-2 as a therapeutic agent for ALS which aims at defining the activity and safety of a range a doses for subsequent use of the best dose in a phase II/III trial. For ethical reasons, ld-IL-2 must be tested as an add-on therapy to riluzole hence all patients will need to be treated with riluzole for at least three months prior to entry. A randomized (1:1:1:1), placebo-controlled, double-blind, parallel group trial will be carried out to assess ld-IL-2 activity on regulatory T cells and immuno-inflammatory markers in ALS patients treated for 3 months (5 days per month). Follow-up will last for 6 months. Blood will be drawn for laboratory analyses regularly throughout the trial. Safety will be assessed via the recording of all adverse events . Certain adverse events commonly found in the scientific literature will be queried directly by participating investigators at follow-up visits. Patients will also be asked to maintain an adverse event journal throughout the study. "Day 1" refers to the day of the first injection.
Between 18 and 75 years of age, both genders with probable or definite ALS diagnosis