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Low-dose IL-2 to the Kinetics of Regulatory T-cell in Healthy Volunteers — HEALTHIL-2  

Healthy Volunteers Clinical Trial

Official title:
A Study of the Dose-response Relationship of Low-dose IL-2 to the Kinetics of Regulatory T-cell Response in Healthy Volunteers

Clinical Trial Summary

The purpose of this study is to evaluate the safety and the dose-response relationship of ILT-101 to blood Tregs.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03837093
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase Phase 1
Start date June 6, 2019
Completion date November 6, 2021
View Details
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