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

Systemic Lupus Erythematosus Clinical Trial

— LUPIL-2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955615
• Other study ID #: 2016-002
• Secondary ID: 2016-000488-17
• Status: Completed
• Phase: Phase 2
• Start date: January 18, 2017
• Est. completion date: February 11, 2019

Study information

• Verified date: March 2019
• Source: Iltoo Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 11, 2019
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• ILT-101
Induction phase followed by weekly administrations of ILT-101 on top of SLE background therapy. SLE background therapy includes ...
• Placebo
Induction phase followed by weekly administrations of placebo on top of SLE background therapy. SLE background therapy includes ...

Locations

Country	Name	City	State
Austria	AKH Wien	Wien
Bulgaria	University Multiprofile Hospital for Active Treatment	Plovdiv
Bulgaria	University Multiprofile Hospital	Sofia
France	Hopital Claude Huriez	Lille
France	Hopital Européen	Marseille
France	Hôpital Haut Lévèque	Pessac
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Klinikum der Johann Wolfgang Goethe-Universität	Frankfurt am Main
Germany	University Clinic Leipzig AöR	Leipzig
Germany	University Clinic Schleswig-Holstein	Lübeck
Italy	Azienda Osp. Univ. Seconda Università di Napoli	Napoli
Mauritius	Cap research	Phoenix
Mexico	Hospital AmeriMed Cons.	Cancun
Mexico	Investigación y Biomedicina	Chihuahua
Mexico	Clitider S.A. de C.V.	Ciudad de Mexico
Mexico	Instituto de Investigaciones Aplicadas a la Neurociencia A.C.	Durango
Mexico	Centro Integral en Reumatología S.A. de C.V.	Guadalajara
Portugal	Hospital Prof. Doutor Fernando Fonseca	Amadora
Portugal	Centro Hospitalar de Lisboa Ocidental	Lisbon
Romania	Neomed	Brasov
Romania	Euroclinic Hospital	Bucuresti
Romania	Sf. Maria Hospital	Bucuresti
Spain	Hospital Vall D'Hebron	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario y Politécnico La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Iltoo Pharma

Countries where clinical trial is conducted

Austria,  Bulgaria,  France,  Germany,  Italy,  Mauritius,  Mexico,  Portugal,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SRI-4 (SLE responder index)	Number of participants with SRI-4	at week 12
Secondary	Incidence of adverse events		From baseline up to week 24 or 36
Secondary	Number of participants able to reduce oral steroid dose of 25 and 50%		From baseline to week 12 or 24
Secondary	Anti ds-DNA by immunology-based assay	Change in anti-dsDNA as compared to baseline	From baseline to week 12 or 24
Secondary	%Tregs	% change in Tregs as compared to baseline	From baseline to week 12 or 24