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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: ILT101

• Registration Number: NCT03837093
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed 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 Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-11
• Study Start: 2019-06-06
• Primary Completion: 2021-03-03
• Study Completion: 2021-11-06
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Without any chronic diseases diagnosed (including allergies);
• Effective contraception> 2 weeks before the first administration of the experimental drug or its placebo and β-hCG negative at the verification of the selection criteria;
• Affiliated to a social security system;
• Free, informed and written consent, signed by the subject and the investigator, before any action required by the research.
• Not taking any treatment

Exclusion Criteria

• Subject in a period of exclusion of participation in other biomedical research;
• Participation in another research ≤ 1 month and during the study except for research Transimmunom (Non-interventional research involving the human person);
• known antecedents of autoimmune diseases;
• Hypersensitivity to any of the excipients of the investigational drug (mannitol, sodium laurilsulfate, monosodium phosphate dihydrate, disodium phosphate dihydrate);
• Evolutionary infection requiring treatment;
• Viral infection and benign infection less than 2 months old;
• Venous capital not allowing blood samples;
• Pregnant or lactating women;
• Men and women of childbearing potential without effective contraception during the study;
• Live attenuated virus vaccination in the month prior to inclusion or during the study;
• Surgical intervention ≤ 2 months or planned during the study;
• Psychiatric pathology or drug addiction that may impair ability to comply with protocol requirements or give informed consent;
• Presence or history of cancer that has not been cured for less than 5 years, except in situ cervical cancer, or basocellular cancer;
• Subject under a legal protection measure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
dose B	ILT101	ILT-101
dose A	ILT101	ILT-101
dose C	ILT101	ILT-101
dose E	ILT101	ILT-101
dose D	ILT101	ILT-101

Primary Outcome Measures

Name	Time	Method
Variation of Tregs(in (expressed in % of CD4 and total)	from Day 1 to Day 5

Secondary Outcome Measures

Name	Time	Method
levels of serum anti-IL-2 autoantibodies	from baseline to Day 60
AUC corresponding to the évolution of residual values of tregs/CD4+	Day 5 to Day 60
numbers of different circulating immune populations	baseline to Day 60
levels of serum cytokine(pg)	from baseline to Day 60
composition of the intestinal microbiota	from baseline to Day 60
levels of serum chemokine	from baseline to Day 60
adverse events, anti IL-2 autoantibodies	from baseline to Day 60

Trial Locations

Locations (1)

Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris; 🇫🇷 Paris, France