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

NCT ID: NCT03837093

Last Updated: 2021-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2021-11-06

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.

Conditions

Healthy Volunteers

Keywords

Low dose of IL-2; Healthy volunteers; Kinetic study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

dose A

ILT-101

Group Type: EXPERIMENTAL

ILT101

Intervention Type: DRUG

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

dose B

ILT-101

Group Type: EXPERIMENTAL

ILT101

Intervention Type: DRUG

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

dose C

ILT-101

Group Type: EXPERIMENTAL

ILT101

Intervention Type: DRUG

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

dose D

ILT-101

Group Type: EXPERIMENTAL

ILT101

Intervention Type: DRUG

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

dose E

ILT-101

Group Type: EXPERIMENTAL

ILT101

Intervention Type: DRUG

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

Placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

Interventions

ILT101

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

low-dose IL-2

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Iltoo Pharma

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Klatzmann, MD

Role: PRINCIPAL_INVESTIGATOR

Investigation Center in Biotherapy et immunology Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris l'hopital 75013 Paris

Roberta Lorenzon, MD

Role: STUDY_DIRECTOR

Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris

Locations

Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris

Paris, , France

Countries

France

Other Identifiers

2018-004123-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MEDAECNAT-2018-11-0048

Identifier Type: OTHER

Identifier Source: secondary_id

2-17-33

Identifier Type: OTHER

Identifier Source: secondary_id

APHP180274

Identifier Type: -

Identifier Source: org_study_id