Overview

This trial is active, not recruiting.

Condition systemic lupus erythematosus
Treatment interleukin-2
Sponsor Peking University People's Hospital
Collaborator Monash University
Start date August 2013
End date November 2014
Trial size 40 participants
Trial identifier NCT02084238, 2014-03

Summary

This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic lupus erythematosus.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Interleukin-2 to treat activated SLE.
interleukin-2 Recombinant Human Interleukin-2,125Ala, SL Pharm
Patients receive low dose recombinant human Interleukin-2(HrIL-2) (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 3-6 courses according to the situation of the disease.

Primary Outcomes

Measure
Number of Participants Who Were SLE Responders (SRI)
time frame: week 2,week 4,week 6,week 8,week 10

Secondary Outcomes

Measure
Immunological Responses
time frame: week 0 and week 10
The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients
time frame: week 0 and week 10
SELENA SLEDAI Score
time frame: week 0, week 10
Number of Relapses
time frame: 24 weeks
Safety Assessment
time frame: up to Day 180

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Meet the American College of Rheumatology criteria for the diagnosis of SLE. - 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. - 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.

Additional Information

Official title Safety and Efficiency Study of Low-dose IL-2 Treatment in Systemic Lupus Erythematosus
Principal investigator Zhanguo Li, MD and PhD
Description Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs. While available therapies, such as corticosteroids and immunosuppressive agents have improved the outcome of patients, there remains a significant unmet need for safe and more effective treatments. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). We hypothesized that low-dose IL-2 could be a novel therapy in active SLE patients. This is a single center, uncontrolled, open-label study to assess the efficacy/safety of low dose IL-2 plus standard therapy in active SLE. Methods: Each SLE patients (n=40) with Scores>=8 on the Safety of Estrogens in Lupus Erythematosus National Assessment (AELENA) version of the SLE Disease Activity Index (SLEDAI) that was refractory or relaps to glucocorticoid therapy received low-dose IL-2 (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 3-6 cycles according to the situation of the disease. The end points were safety and clinical and immunologic response. Expected Results: This trail will define low-dose IL-2 plus standard therapy is efficacy and safety with active lupus patients, which could be relevant to the amelioration the abnormity of T help cells in SLE patients.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Peking University People's Hospital.