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

March 4, 2019 updated by: Iltoo Pharma

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Akh Wien
  • Bulgaria
      • Plovdiv, Bulgaria
        • University Multiprofile Hospital for Active Treatment
      • Sofia, Bulgaria
        • University Multiprofile Hospital
  • France
      • Lille, France, 59037
        • Hopital Claude Huriez
      • Marseille, France, 13003
        • Hôpital Européen
      • Pessac, France, 33604
        • Hôpital Haut Lévêque
  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Frankfurt am Main, Germany, 60528
        • Klinikum der Johann Wolfgang Goethe-Universität
      • Leipzig, Germany, 04103
        • University clinic Leipzig AÖR
      • Lübeck, Germany, 23562
        • University Clinic Schleswig-Holstein
  • Italy
      • Napoli, Italy
        • Azienda Osp. Univ. Seconda Università di Napoli
  • Mauritius
      • Phoenix, Mauritius
        • CAP Research
  • Mexico
      • Cancun, Mexico
        • Hospital AmeriMed Cons.
      • Chihuahua, Mexico
        • Investigación y Biomedicina
      • Ciudad de Mexico, Mexico, 06700
        • Clitider S.A. de C.V.
      • Durango, Mexico
        • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
      • Guadalajara, Mexico
        • Centro Integral en Reumatología S.A. de C.V.
  • Portugal
      • Amadora, Portugal
        • Hospital Prof. Doutor Fernando Fonseca
      • Lisbon, Portugal
        • Centro Hospitalar de Lisboa Ocidental
  • Romania
      • Braşov, Romania
        • Neomed
      • Bucuresti, Romania
        • Euroclinic Hospital
      • Bucuresti, Romania
        • Sf. Maria Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Valencia, Spain
        • Hospital Universitario Y Politecnico La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ILT-101
Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
Drug: ILT-101

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

SLE background therapy includes ...

Other Names:
  • Low dose IL-2
Placebo Comparator: Placebo
Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
Drug: Placebo

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

SLE background therapy includes ...

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SRI-4 (SLE responder index)
Time Frame: at week 12
Number of participants with SRI-4
at week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: From baseline up to week 24 or 36
From baseline up to week 24 or 36
Number of participants able to reduce oral steroid dose of 25 and 50%
Time Frame: From baseline to week 12 or 24
From baseline to week 12 or 24
Anti ds-DNA by immunology-based assay
Time Frame: From baseline to week 12 or 24
Change in anti-dsDNA as compared to baseline
From baseline to week 12 or 24
%Tregs
Time Frame: From baseline to week 12 or 24
% change in Tregs as compared to baseline
From baseline to week 12 or 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iltoo Pharma

Investigators

  • Principal Investigator: David Klatzmann, MD, PhD, Assistance Publique Hôpitaux de Paris (AP-HP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2017

Primary Completion (Actual)

August 27, 2018

Study Completion (Actual)

February 11, 2019

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-002
  • 2016-000488-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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