Low-dose IL-2( Interleukin-2) Treatment in SLE
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|ClinicalTrials.gov Identifier: NCT02084238|
Recruitment Status : Completed
First Posted : March 11, 2014
Results First Posted : April 13, 2015
Last Update Posted : April 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: Interleukin-2||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficiency Study of Low-dose IL-2 Treatment in Systemic Lupus Erythematosus|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||October 2015|
Interleukin-2 to treat activated SLE.
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.
Other Name: Recombinant Human Interleukin-2,125Ala, SL Pharm
- Number of Participants Who Were SLE Responders (SRI) [ Time Frame: week 2，week 4，week 6，week 8，week 10 ]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.
- Immunological Responses [ Time Frame: week 0 and week 10 ]Analysis regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells before and during IL-2 treatment. P values below 0.05 are considered statistically significant in this study.
- The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients [ Time Frame: week 0 and week 10 ]Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres.
- SELENA SLEDAI Score [ Time Frame: week 0, week 10 ]Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change. The higher the score represent the worse of the disease. The total score ranges from 0 to 105 points, score> 8 means the disease is moderate-to-severe active".
- Number of Relapses [ Time Frame: 24 weeks ]Relapses mean that if the patient's SELENA SLEDAI Score is lower than 4 during the treatment, while the SELENA SLEDAI Score increase after stopping using the study drugs in 3 months.
- Safety Assessment [ Time Frame: up to Day 180 ]Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.
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): NCT02084238
|Department of Rheumatology and Immunology, Peking University People's Hospital|
|Beijing, Beijing, China, 100044|
|Principal Investigator:||Zhanguo Li, MD and PhD||Peking University Institute of Rheumatology and Immunology|