MIROCALS: Modifying Immune Response and OutComes in ALS
Status:
Active, not recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
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. 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.