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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- 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.
- 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.
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
|Contact: Tian Liu, MDfirstname.lastname@example.org|
|Contact: Jing He, MDemail@example.com|
|Department of Rheumatology and Immunology, Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100044|
|Contact: Tian Liu, MD 8613661345637 firstname.lastname@example.org|
|Principal Investigator:||Zhanguo Li, MD||Peking University Institute of Rheumatology and Immunology|