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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02465580
• Other study ID #: hrIL-2-SLE
• Status: Recruiting
• Phase: Phase 2
• First received: June 3, 2015
• Last updated: June 4, 2015
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2015
• Source: Peking University People's Hospital
• Contact: Tian Liu, MD
• Phone: 8613661345637
• Email: mikle317[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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)).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• hrIL-2 active
active group: placebo group =1:1
• hrIL-2 placebo
active group: placebo group =1:1

Locations

Country	Name	City	State
China	Department of Rheumatology and Immunology, Peking University People's Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing ShuangLu Pharmaceutical Co., Ltd., Monash University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week 24	Yes
Primary	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.	24 weeks	Yes