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

NCT ID: NCT02955615

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-18
• Study Completion Date: 2019-02-11

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ILT-101

Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12

Group Type: EXPERIMENTAL

ILT-101

Intervention Type: DRUG

Induction phase followed by weekly administrations of ILT-101 on top of SLE background therapy.

SLE background therapy includes ...

Placebo

Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Induction phase followed by weekly administrations of placebo on top of SLE background therapy.

SLE background therapy includes ...

Interventions

ILT-101

Induction phase followed by weekly administrations of ILT-101 on top of SLE background therapy.

SLE background therapy includes ...

Intervention Type: DRUG

Placebo

Induction phase followed by weekly administrations of placebo on top of SLE background therapy.

SLE background therapy includes ...

Intervention Type: DRUG

Other Intervention Names

Low dose IL-2

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iltoo Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Klatzmann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hôpitaux de Paris (AP-HP)

Locations

AKH Wien

Vienna, , Austria

University Multiprofile Hospital for Active Treatment

Plovdiv, , Bulgaria

University Multiprofile Hospital

Sofia, , Bulgaria

Hopital Claude Huriez

Lille, , France

Hopital Européen

Marseille, , France

Hôpital Haut Lévèque

Pessac, , France

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, , Germany

Azienda Osp. Univ. Seconda Università di Napoli

Napoli, , Italy

Cap research

Phoenix, , Mauritius

Hospital AmeriMed Cons.

Cancún, , Mexico

Investigación y Biomedicina

Chihuahua City, , Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, , Mexico

Centro Integral en Reumatología S.A. de C.V.

Guadalajara, , Mexico

Clitider S.A. de C.V.

Mexico City, , Mexico

Hospital Prof. Doutor Fernando Fonseca

Amadora, , Portugal

Centro Hospitalar de Lisboa Ocidental

Lisbon, , Portugal

Neomed

Brasov, , Romania

Euroclinic Hospital

Bucharest, , Romania

Sf. Maria Hospital

Bucharest, , Romania

Hospital Vall D'Hebron

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario y Politécnico La Fe

Valencia, , Spain

Countries

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

References

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.

Reference Type: DERIVED

PMID: 35973803 (View on PubMed)

Other Identifiers

2016-000488-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2016-002

Identifier Type: -

Identifier Source: org_study_id