ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE) (LUPIL-2)

Iltoo Pharma

Status and phase

Completed

Phase 2

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: ILT-101

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02955615

2016-002

2016-000488-17 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of ILT-101 (human recombinant interleukin 2 (IL-2)) in patients with moderate to severe systemic lupus erythematosus.

Full description

Interleukin 2 (IL-2) plays an important role on immune homeostasis by acting on T lymphocytes. In systemic lupus erythematosus, there is a so called "insufficiency" in a subpopulation of T lymphocytes, the regulatory T cells (Tregs) leading to altered immune balance between regulatory and effector T cells. These cells seem to play a major role in the physiopathology of the disease. Many researches enlighten the fact that this Tregs/Teffs balance can be restored by administering low dose of IL-2. It is thus assumed that treatment with low dose of IL-2 may impact positively the progression of the disease and thus help patients improving their clinical outcomes.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Confirmed diagnosis of SLE
Active SLE
On stable background therapy for 1 month
Using highly effective contraception

Exclusion criteria

Serious organ failure (renal functional impairment, severe central nervous system manifestations, severe heart failure, liver failure)
Any clinical evidence of active chronic infection HIV, hepatitis B, hepatitis C
Clinical significant pleuritis or pericarditis
Type1 Diabetes and/or CROHN's disease
Use of Benlysta (belimumab) in the past 4 weeks
Use of Rituximab in the past 6 months
Vaccination with live attenuated virus in the last month