The purpose of this study is to evaluate the safety and the dose-response relationship of ILT-101 to blood Tregs.
In the healthy physiological state, there is homeostasis between regulatory T cells (Tregs) and effector T cells (Teffs) which is deregulated in autoimmune diseases (AID). The existence of an AID indicates a lack of Tregs. Our team has discovered that low-dose interleukin-2 (ld-IL2) activates and specifically increases Tregs in humans and thus may improve AID. Exploiting this potential requires i) to better target the dose with the best benefit / risk ratio and also ii) to better understand the mechanism of action of this molecule through clinical trials of ld-IL2 in progress, including in type 1 diabetes, multiple sclerosis and systemic lupus erythematosus. During these clinical trials, a very thorough immunological follow-up is carried out in order to discover biomarkers of treatment efficacy. Exploitation of these results will benefit both the cross-analysis of the effects of IL-2 in these 3 diseases with distinct pathophysiologies, but also very importantly a comparison with the effects of ld-IL2 at the healthy volunteer. These analyzes should make it possible to define the most effective dose of IL-2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
40
Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks
Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks
Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris
Paris, France
Variation of Tregs(in (expressed in % of CD4 and total)
Time frame: from Day 1 to Day 5
AUC corresponding to the évolution of residual values of tregs/CD4+
Time frame: Day 5 to Day 60
numbers of different circulating immune populations
Time frame: baseline to Day 60
levels of serum cytokine(pg)
Time frame: from baseline to Day 60
levels of serum chemokine
Time frame: from baseline to Day 60
composition of the intestinal microbiota
Time frame: from baseline to Day 60
adverse events, anti IL-2 autoantibodies
Time frame: from baseline to Day 60
levels of serum anti-IL-2 autoantibodies
Time frame: from baseline to Day 60
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