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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: ILT-101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ILT-101<br>Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12 | Drug: ILT-101<br>* Induction phase followed by weekly administrations of ILT-101 on top of SLE background therapy. SLE background therapy includes ...<br>* Other names: Low dose IL-2;|
| Placebo Comparator: Placebo<br>Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12 | Drug: Placebo<br>* Induction phase followed by weekly administrations of placebo on top of SLE background therapy. SLE background therapy includes ...<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SRI-4 (SLE responder index) | Number of participants with SRI-4 | at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | From baseline up to week 24 or 36 | 
| Number of participants able to reduce oral steroid dose of 25 and 50% |  | From baseline to week 12 or 24 | 
| Anti ds-DNA by immunology-based assay | Change in anti-dsDNA as compared to baseline | From baseline to week 12 or 24 | 
| %Tregs | % change in Tregs as compared to baseline | From baseline to week 12 or 24 |