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

Iltoo Pharma100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Systemic Lupus Erythematosus

Interventions

ILT-101DRUG

Induction phase followed by weekly administrations of ILT-101 on top of SLE background therapy. SLE background therapy includes ...

PlaceboDRUG

Induction phase followed by weekly administrations of placebo on top of SLE background therapy. SLE background therapy includes ...

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (25)

AKH Wien

Vienna, Austria

Outcomes

Primary Outcomes

SRI-4 (SLE responder index)

Number of participants with SRI-4

Time frame: at week 12

Secondary Outcomes

Incidence of adverse events

Time frame: From baseline up to week 24 or 36

Number of participants able to reduce oral steroid dose of 25 and 50%

Time frame: From baseline to week 12 or 24

Anti ds-DNA by immunology-based assay

Change in anti-dsDNA as compared to baseline

Time frame: From baseline to week 12 or 24

%Tregs

% change in Tregs as compared to baseline

Time frame: From baseline to week 12 or 24

Data from ClinicalTrials.gov

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