ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)
LUPIL-2
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)
2 other identifiers
interventional
100
10 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2017
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2016
CompletedFirst Posted
Study publicly available on registry
November 4, 2016
CompletedStudy Start
First participant enrolled
January 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2019
CompletedMarch 5, 2019
March 1, 2019
1.6 years
October 17, 2016
March 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
SRI-4 (SLE responder index)
Number of participants with SRI-4
at week 12
Secondary Outcomes (4)
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
%Tregs
From baseline to week 12 or 24
Study Arms (2)
ILT-101
EXPERIMENTALSubcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
Placebo
PLACEBO COMPARATORSubcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
Interventions
Induction phase followed by weekly administrations of ILT-101 on top of SLE background therapy. SLE background therapy includes ...
Induction phase followed by weekly administrations of placebo on top of SLE background therapy. SLE background therapy includes ...
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of SLE
- Active SLE
- On stable background therapy for 1 month
- Using highly effective contraception
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Iltoo Pharmalead
Study Sites (25)
AKH Wien
Vienna, 1090, Austria
University Multiprofile Hospital for Active Treatment
Plovdiv, Bulgaria
University Multiprofile Hospital
Sofia, Bulgaria
Hopital Claude Huriez
Lille, 59037, France
Hopital Européen
Marseille, 13003, France
Hôpital Haut Lévèque
Pessac, 33604, France
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt am Main, 60528, Germany
University Clinic Leipzig AöR
Leipzig, 04103, Germany
University Clinic Schleswig-Holstein
Lübeck, 23562, 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, 06700, 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, 08035, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Related Publications (1)
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.
PMID: 35973803DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Klatzmann, MD, PhD
Assistance Publique Hôpitaux de Paris (AP-HP)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2016
First Posted
November 4, 2016
Study Start
January 18, 2017
Primary Completion
August 27, 2018
Study Completion
February 11, 2019
Last Updated
March 5, 2019
Record last verified: 2019-03