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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02955615
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Iltoo Pharma

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: ILT-101 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 18, 2017
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : February 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

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 Name: 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 ...





Primary Outcome Measures :
  1. SRI-4 (SLE responder index) [ Time Frame: at week 12 ]
    Number of participants with SRI-4


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: From baseline up to week 24 or 36 ]
  2. Number of participants able to reduce oral steroid dose of 25 and 50% [ Time Frame: From baseline to week 12 or 24 ]
  3. Anti ds-DNA by immunology-based assay [ Time Frame: From baseline to week 12 or 24 ]
    Change in anti-dsDNA as compared to baseline

  4. %Tregs [ Time Frame: From baseline to week 12 or 24 ]
    % change in Tregs as compared to baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955615


Locations
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Austria
AKH Wien
Wien, Austria, 1090
Bulgaria
University Multiprofile Hospital for Active Treatment
Plovdiv, Bulgaria
University Multiprofile Hospital
Sofia, Bulgaria
France
Hopital Claude Huriez
Lille, France, 59037
Hopital Européen
Marseille, France, 13003
Hôpital Haut Lévèque
Pessac, France, 33604
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt am Main, Germany, 60528
University Clinic Leipzig AöR
Leipzig, Germany, 04103
University Clinic Schleswig-Holstein
Lübeck, Germany, 23562
Italy
Azienda Osp. Univ. Seconda Università di Napoli
Napoli, Italy
Mauritius
Cap research
Phoenix, Mauritius
Mexico
Hospital AmeriMed Cons.
Cancun, Mexico
Investigación y Biomedicina
Chihuahua, Mexico
Clitider S.A. de C.V.
Ciudad de Mexico, Mexico, 06700
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, Mexico
Centro Integral en Reumatología S.A. de C.V.
Guadalajara, Mexico
Portugal
Hospital Prof. Doutor Fernando Fonseca
Amadora, Portugal
Centro Hospitalar de Lisboa Ocidental
Lisbon, Portugal
Romania
Neomed
Braşov, Romania
Euroclinic Hospital
Bucuresti, Romania
Sf. Maria Hospital
Bucuresti, Romania
Spain
Hospital Vall D'Hebron
Barcelona, Spain, 08035
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Sponsors and Collaborators
Iltoo Pharma
Investigators
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Principal Investigator: David Klatzmann, MD, PhD Assistance Publique Hôpitaux de Paris (AP-HP)

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Responsible Party: Iltoo Pharma
ClinicalTrials.gov Identifier: NCT02955615     History of Changes
Other Study ID Numbers: 2016-002
2016-000488-17 ( EudraCT Number )
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases