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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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)).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborators: Beijing ShuangLu Pharmaceutical Co., Ltd.; Monash University

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.