Anti-infection of Low-does IL-2 in SLE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-05

Study Completion Date

2017-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this clinical study is to evaluate the potential effect of anti-infection of low-does IL-2 in patients with SLE.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Low-dose IL-2( Interleukin-2) Treatment in SLE

NCT02084238

Systemic Lupus Erythematosus

COMPLETED NA

Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial

NCT04077684

Systemic Lupus Erythematosus

COMPLETED PHASE2

The Incidence of Infection in Treatment of Low-dose IL-2 of SLE Patients

NCT04136106

Infection

UNKNOWN

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

NCT02465580

Systemic Lupus Erythematosus

UNKNOWN PHASE2

Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus

NCT05262686

Systemic Lupus Erythematosus

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs.Many feel that glucocorticoid and immunosuppressor are the standard therapy for patients with SLE. While it can improve the risk of infection among SLE patients. A novel therapy to treat SLE with low-does IL-2 has been identified recently. IL-2 also used to against some virus infect. So we hypothesized that low-dose IL-2 could reduce risk of infection in SLE patients.

Methods: A total of SLE patients (n=30) were divided into two groups randomly. One received standard therapy, while another one administrate with low-does IL-2 plus standard therapy.Each patient will be treated with low-dose IL-2. The end points are clinical and immunologic response.

Expected Results: This trail wlii provide both clinical and basic profe that low-dose IL-2 plus standard therapy have lower infection risk in SLE patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Lupus Erythematosus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interleukin-2

Interleukin-2 to treat activated SLE.

Group Type EXPERIMENTAL

Interleukin-2

Intervention Type DRUG

Patients receive low dose recombinant human Interleukin-2（HrIL-2）

Traditional therapy

Treat activated SLE with glucocorticoid or immunosuppressor.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interleukin-2

Patients receive low dose recombinant human Interleukin-2（HrIL-2）

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Recombinant Human Interleukin-2,125Ala, SL Pharm

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No