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ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE) (LUPIL-2)

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ILT-101
Placebo
Sponsored by
Iltoo Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AKH Wien
  • University Multiprofile Hospital for Active Treatment
  • University Multiprofile Hospital
  • Hopital Claude Huriez
  • Hopital Européen
  • Hôpital Haut Lévèque
  • Charité - Universitätsmedizin Berlin
  • Klinikum der Johann Wolfgang Goethe-Universität
  • University Clinic Leipzig AöR
  • University Clinic Schleswig-Holstein
  • Azienda Osp. Univ. Seconda Università di Napoli
  • Cap research
  • Hospital AmeriMed Cons.
  • Investigación y Biomedicina
  • Clitider S.A. de C.V.
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Centro Integral en Reumatología S.A. de C.V.
  • Hospital Prof. Doutor Fernando Fonseca
  • Centro Hospitalar de Lisboa Ocidental
  • Neomed
  • Euroclinic Hospital
  • Sf. Maria Hospital
  • Hospital Vall D'Hebron
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario y Politécnico La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ILT-101

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

SRI-4 (SLE responder index)
Number of participants with SRI-4

Secondary Outcome Measures

Incidence of adverse events
Number of participants able to reduce oral steroid dose of 25 and 50%
Anti ds-DNA by immunology-based assay
Change in anti-dsDNA as compared to baseline
%Tregs
% change in Tregs as compared to baseline

Full Information

First Posted
October 17, 2016
Last Updated
March 4, 2019
Sponsor
Iltoo Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02955615
Brief Title
ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
August 27, 2018 (Actual)
Study Completion Date
February 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iltoo Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ILT-101
Arm Type
Experimental
Arm Description
Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
Intervention Type
Drug
Intervention Name(s)
ILT-101
Other Intervention Name(s)
Low dose IL-2
Intervention Description
Induction phase followed by weekly administrations of ILT-101 on top of SLE background therapy. SLE background therapy includes ...
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Induction phase followed by weekly administrations of placebo on top of SLE background therapy. SLE background therapy includes ...
Primary Outcome Measure Information:
Title
SRI-4 (SLE responder index)
Description
Number of participants with SRI-4
Time Frame
at week 12
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
From baseline up to week 24 or 36
Title
Number of participants able to reduce oral steroid dose of 25 and 50%
Time Frame
From baseline to week 12 or 24
Title
Anti ds-DNA by immunology-based assay
Description
Change in anti-dsDNA as compared to baseline
Time Frame
From baseline to week 12 or 24
Title
%Tregs
Description
% change in Tregs as compared to baseline
Time Frame
From baseline to week 12 or 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Klatzmann, MD, PhD
Organizational Affiliation
Assistance Publique Hôpitaux de Paris (AP-HP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
University Multiprofile Hospital for Active Treatment
City
Plovdiv
Country
Bulgaria
Facility Name
University Multiprofile Hospital
City
Sofia
Country
Bulgaria
Facility Name
Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Européen
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Hôpital Haut Lévèque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universität
City
Frankfurt am Main
ZIP/Postal Code
60528
Country
Germany
Facility Name
University Clinic Leipzig AöR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
University Clinic Schleswig-Holstein
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Azienda Osp. Univ. Seconda Università di Napoli
City
Napoli
Country
Italy
Facility Name
Cap research
City
Phoenix
Country
Mauritius
Facility Name
Hospital AmeriMed Cons.
City
Cancun
Country
Mexico
Facility Name
Investigación y Biomedicina
City
Chihuahua
Country
Mexico
Facility Name
Clitider S.A. de C.V.
City
Ciudad de Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
City
Durango
Country
Mexico
Facility Name
Centro Integral en Reumatología S.A. de C.V.
City
Guadalajara
Country
Mexico
Facility Name
Hospital Prof. Doutor Fernando Fonseca
City
Amadora
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Ocidental
City
Lisbon
Country
Portugal
Facility Name
Neomed
City
Braşov
Country
Romania
Facility Name
Euroclinic Hospital
City
Bucuresti
Country
Romania
Facility Name
Sf. Maria Hospital
City
Bucuresti
Country
Romania
Facility Name
Hospital Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35973803
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.
Results Reference
derived

Learn more about this trial

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

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