Systemic Lupus Erythematosus
Conditions
Brief summary
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
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.
Interventions
DRUGILT-101
Induction phase followed by weekly administrations of ILT-101 on top of SLE background therapy. SLE background therapy includes ...
DRUGPlacebo
Induction phase followed by weekly administrations of placebo on top of SLE background therapy. SLE background therapy includes ...
Sponsors
Iltoo Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SRI-4 (SLE responder index) | at week 12 | Number of participants with SRI-4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From baseline to week 12 or 24 | Change in anti-dsDNA as compared to baseline |
| %Tregs | From baseline to week 12 or 24 | % change in Tregs as compared to baseline |
Countries
Austria, Bulgaria, France, Germany, Italy, Mauritius, Mexico, Portugal, Romania, Spain
Outcome results
None listed