Clinical trial NCT02955615: ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Iltoo Pharma
Sponsor class: INDUSTRY
First posted: 2016-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: SRI-4 (SLE responder index)
timeFrame: at week 12
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: From baseline up to week 24 or 36
measure: Number of participants able to reduce oral steroid dose of 25 and 50%
timeFrame: From baseline to week 12 or 24
measure: Anti ds-DNA by immunology-based assay
timeFrame: From baseline to week 12 or 24
measure: %Tregs
timeFrame: From baseline to week 12 or 24
Other outcomes:
Locations:
city: Wien
country: Austria
facility: AKH Wien
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital
city: Lille
country: France
facility: Hopital Claude Huriez
city: Marseille
country: France
facility: Hopital Européen
city: Pessac
country: France
facility: Hôpital Haut Lévèque
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität
city: Leipzig
country: Germany
facility: University Clinic Leipzig AöR
city: Lübeck
country: Germany
facility: University Clinic Schleswig-Holstein
city: Napoli
country: Italy
facility: Azienda Osp. Univ. Seconda Università di Napoli
city: Phoenix
country: Mauritius
facility: Cap research
city: Cancun
country: Mexico
facility: Hospital AmeriMed Cons.
city: Chihuahua
country: Mexico
facility: Investigación y Biomedicina
city: Ciudad de Mexico
country: Mexico
facility: Clitider S.A. de C.V.
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatología S.A. de C.V.
city: Amadora
country: Portugal
facility: Hospital Prof. Doutor Fernando Fonseca
city: Lisbon
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental
city: Braşov
country: Romania
facility: Neomed
city: Bucuresti
country: Romania
facility: Euroclinic Hospital
city: Bucuresti
country: Romania
facility: Sf. Maria Hospital
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
affiliation: Assistance Publique Hôpitaux de Paris (AP-HP)
name: David Klatzmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Humrich JY, Cacoub P, Rosenzwajg M, Pitoiset F, Pham HP, Guidoux J, Leroux D, Vazquez T, Riemekasten G, Smolen JS, Tsokos G, Klatzmann D. Low-dose interleukin-2 therapy in active systemic lupus erythematosus (LUPIL-2): a multicentre, double-blind, randomised and placebo-controlled phase II trial. Ann Rheum Dis. 2022 Dec;81(12):1685-1694. doi: 10.1136/ard-2022-222501. Epub 2022 Aug 16.