Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2
The primary objective is to evaluate in ALS patients the regulatory T cell early response to two low-doses of IL-2 at 1 and 2 MIU per day after one course of 5 consecutive days comparatively to placebo.
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), 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 every four weeks repeated three times).
The secondary objectives of this study are:
A. To evaluate maintenance of Tcell response after three repeated 5-day courses at one
course every four weeks for 12 weeks.
B. To evaluate the safety of ld-IL-2 therapy in an ALS population, with an overall follow-up
of 6 months (up to 15 weeks after last administration); C. To evaluate functional changes
throughout the study; D. To evaluate changes in other pre-defined blood cytology parameters,
and a blood biomarker for axonal damage.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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