ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)
- Registration Number
- NCT02955615
- Lead Sponsor
- Iltoo Pharma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Confirmed diagnosis of SLE
- Active SLE
- On stable background therapy for 1 month
- Using highly effective contraception
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ILT-101 ILT-101 Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12 Placebo Placebo Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
- Primary Outcome Measures
Name Time Method SRI-4 (SLE responder index) at week 12 Number of participants with SRI-4
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (25)
Hospital Universitario y Politécnico La Fe
🇪🇸Valencia, Spain
Investigación y Biomedicina
🇲🇽Chihuahua, Mexico
Clitider S.A. de C.V.
🇲🇽Ciudad de Mexico, Mexico
AKH Wien
🇦🇹Wien, Austria
University Multiprofile Hospital for Active Treatment
🇧🇬Plovdiv, Bulgaria
Hopital Claude Huriez
🇫🇷Lille, France
Hopital Européen
🇫🇷Marseille, France
University Multiprofile Hospital
🇧🇬Sofia, Bulgaria
Hôpital Haut Lévèque
🇫🇷Pessac, France
Klinikum der Johann Wolfgang Goethe-Universität
🇩🇪Frankfurt am Main, Germany
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
University Clinic Schleswig-Holstein
🇩🇪Lübeck, Germany
University Clinic Leipzig AöR
🇩🇪Leipzig, Germany
Azienda Osp. Univ. Seconda Università di Napoli
🇮🇹Napoli, Italy
Hospital AmeriMed Cons.
🇲🇽Cancun, Mexico
Cap research
🇲🇺Phoenix, Mauritius
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
🇲🇽Durango, Mexico
Centro Integral en Reumatología S.A. de C.V.
🇲🇽Guadalajara, Mexico
Hospital Prof. Doutor Fernando Fonseca
🇵🇹Amadora, Portugal
Neomed
🇷🇴Braşov, Romania
Centro Hospitalar de Lisboa Ocidental
🇵🇹Lisbon, Portugal
Euroclinic Hospital
🇷🇴Bucuresti, Romania
Sf. Maria Hospital
🇷🇴Bucuresti, Romania
Hospital Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain