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

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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

Tracking Information
First Submitted Date  ICMJE October 17, 2016
First Posted Date  ICMJE November 4, 2016
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE January 18, 2017
Actual Primary Completion Date August 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
SRI-4 (SLE responder index) [ Time Frame: at week 12 ]
Number of participants with SRI-4
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
  • Incidence of adverse events [ Time Frame: 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 ]
  • Anti ds-DNA by immunology-based assay [ Time Frame: From baseline to week 12 or 24 ]
    Change in anti-dsDNA as compared to baseline
  • %Tregs [ Time Frame: From baseline to week 12 or 24 ]
    % change in Tregs as compared to baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • 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
  • Drug: Placebo

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

    SLE background therapy includes ...

Study Arms  ICMJE
  • Experimental: ILT-101
    Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
    Intervention: Drug: ILT-101
  • Placebo Comparator: Placebo
    Subcutaneous administrations for 3 to 6 months according to clinical responder status at week 12
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 11, 2019
Actual Primary Completion Date August 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Bulgaria,   France,   Germany,   Italy,   Mauritius,   Mexico,   Portugal,   Romania,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02955615
Other Study ID Numbers  ICMJE 2016-002
2016-000488-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Iltoo Pharma
Study Sponsor  ICMJE Iltoo Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Klatzmann, MD, PhD Assistance Publique Hôpitaux de Paris (AP-HP)
PRS Account Iltoo Pharma
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP