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

Primary Purpose

Systemic Lupus Erythematosus

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
hrIL-2 active
hrIL-2 placebo
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Rheumatology and Immunology, Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

hrIL-2 active

hrIL-2 placebo

Arm Description

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

1 million U doses of placebo s.c. injection

Outcomes

Primary Outcome Measures

Number of Participants Who Were SLE Responders (SRI)
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.
Evaluation of the safety (type and number of adverse events and serious adverse events) of low-doseIL-2 in patients with SLE
Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2015
Last Updated
June 4, 2015
Sponsor
Peking University People's Hospital
Collaborators
Monash University, Beijing ShuangLu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02465580
Brief Title
A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus
Official Title
A Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Monash University, Beijing ShuangLu Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)).
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.

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
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hrIL-2 active
Arm Type
Active Comparator
Arm Description
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
Arm Title
hrIL-2 placebo
Arm Type
Placebo Comparator
Arm Description
1 million U doses of placebo s.c. injection
Intervention Type
Drug
Intervention Name(s)
hrIL-2 active
Other Intervention Name(s)
Human recombinant IL-2
Intervention Description
active group: placebo group =1:1
Intervention Type
Drug
Intervention Name(s)
hrIL-2 placebo
Intervention Description
active group: placebo group =1:1
Primary Outcome Measure Information:
Title
Number of Participants Who Were SLE Responders (SRI)
Description
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.
Time Frame
week 24
Title
Evaluation of the safety (type and number of adverse events and serious adverse events) of low-doseIL-2 in patients with SLE
Description
Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tian Liu, MD
Phone
8613661345637
Email
mikle317@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing He, MD
Phone
8618611707347
Email
hejing1105@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhanguo Li, MD
Organizational Affiliation
Peking University Institute of Rheumatology and Immunology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology and Immunology, Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tian Liu, MD
Phone
8613661345637
Email
mikle317@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34116715
Citation
Miao M, Xiao X, Tian J, Zhufeng Y, Feng R, Zhang R, Chen J, Zhang X, Huang B, Jin Y, Sun X, He J, Li Z. Therapeutic potential of targeting Tfr/Tfh cell balance by low-dose-IL-2 in active SLE: a post hoc analysis from a double-blind RCT study. Arthritis Res Ther. 2021 Jun 11;23(1):167. doi: 10.1186/s13075-021-02535-6.
Results Reference
derived
PubMed Identifier
33687069
Citation
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Results Reference
derived
PubMed Identifier
31537547
Citation
He J, Zhang R, Shao M, Zhao X, Miao M, Chen J, Liu J, Zhang X, Zhang X, Jin Y, Wang Y, Zhang S, Zhu L, Jacob A, Jia R, You X, Li X, Li C, Zhou Y, Yang Y, Ye H, Liu Y, Su Y, Shen N, Alexander J, Guo J, Ambrus J, Lin X, Yu D, Sun X, Li Z. Efficacy and safety of low-dose IL-2 in the treatment of systemic lupus erythematosus: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2020 Jan;79(1):141-149. doi: 10.1136/annrheumdis-2019-215396. Epub 2019 Sep 19.
Results Reference
derived

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

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