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A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT02465580
Recruitment Status : Unknown
Verified June 2015 by Zhanguo Li, Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Sponsor:
Collaborators:
Monash University
Beijing ShuangLu Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Zhanguo Li, Peking University People's Hospital

Study Description
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Brief Summary:

Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by the investigator's group, the investigators found that the Low-dose IL-2 was effective and well tolerated in active SLE, and the effect was associated with selective modulation of CD4+ T cell subsets.

This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE.

The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: hrIL-2 active Drug: hrIL-2 placebo Phase 2

Detailed Description:
Each SLE patients (n=60) with Scores>=8 on SLEDAI received low-dose IL-2 or placebo (active group: placebo group =1:1, 1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety and clinical and immunologic response.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: hrIL-2 active
Intervention：Add hrIL-2 according to the protocol to original treatment. HrIL-2 active: 1 million U doses of human recombinant interleukin-2 s.c. injection
 Drug: hrIL-2 active
active group: placebo group =1:1
Other Name: Human recombinant IL-2
Placebo Comparator: hrIL-2 placebo
1 million U doses of placebo s.c. injection
 Drug: hrIL-2 placebo
active group: placebo group =1:1


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Who Were SLE Responders (SRI) [ Time Frame: week 24 ]
    SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.

  2. Evaluation of the safety (type and number of adverse events and serious adverse events) of low-doseIL-2 in patients with SLE [ Time Frame: 24 weeks ]
    Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet the American College of Rheumatology criteria for the diagnosis of SLE，1997.
  • Under standard treatment (≥ 2 months) at the time of inclusion
  • Background treatment failed to control flares or to permit prednisone tapering
  • With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria>0.5g/day), neuropsychiatric SLE.
  • Positive for at least one of the following laboratory tests: ANA>1:160, anti-dsDNA, immunoglobulin>20g/L, decreased C3 or C4, leukopenia<3×10^9/L, thrombocytopenia<100×10^9/L;
  • SLE disease activity index(SLEDAI) ≥ 8.
  • Negative HIV test.
  • Negative for hepatitis B and C virus.
  • Negative urine pregnancy test.
  • Written informed consent form.

Exclusion Criteria:

  • Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases> 3N) )
  • Serious infection such as bacteremia, sepsis;
  • Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
  • High-dose steroid pulse therapy (>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months.
  • History of administration of rituximab or other biologics;
  • Purified protein derivative (tuberculin) >10mm
  • Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
  • Inability to comply with IL-2 treatment regimen.
Contacts and Locations
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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): NCT02465580


Contacts
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Contact: Tian Liu, MD 8613661345637 mikle317@163.com
Contact: Jing He, MD 8618611707347 hejing1105@126.com

Locations
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China, Beijing
Department of Rheumatology and Immunology, Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Tian Liu, MD    8613661345637    mikle317@163.com   
Sponsors and Collaborators
Peking University People's Hospital
Monash University
Beijing ShuangLu Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Zhanguo Li, MD Peking University Institute of Rheumatology and Immunology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhanguo Li, Dept. Rheumatology and Immunology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02465580     History of Changes
Other Study ID Numbers: hrIL-2-SLE
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases