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

NCT02465580 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-06-08

No results posted yet for this study

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)).

Conditions

Interventions

DRUG

hrIL-2 active

active group: placebo group =1:1

DRUG

hrIL-2 placebo

active group: placebo group =1:1

Sponsors & Collaborators

  • Monash University

    collaborator OTHER

  • Beijing ShuangLu Pharmaceutical Co., Ltd.

    collaborator OTHER

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Zhanguo Li, MD · Peking University Institute of Rheumatology and Immunology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02465580 on ClinicalTrials.gov