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A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's Syndrome

NCT02464319 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-03-15

No results posted yet for this study

Summary

Primary Sjögren's Syndrome (pSS) is an autoimmune disorder characterized by keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations may develop. Several immunomodulating agents have been attempted in the treatment of pSS without achieving satisfactory results. Currently, there is no approved systemic treatment for pSS. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose IL-2 could be a novel therapy in active pSS patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment in pSS. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in pSS. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for primary Sjögren's Syndrome by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).

Conditions

  • Primary Sjögren's Syndrome

Interventions

DRUG

hrIL-2 active

1 million U doses of human recombinant interleukin-2 s.c. injection active group: placebo group =1:1

DRUG

hrIL-2 placebo

1 million U doses of placebo s.c. injection 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, PhD · Peking University Institute of Rheumatology and Immunology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2017-03-31
Completion
2017-08-31

Countries

  • China

Study Locations

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Entities

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 NCT02464319 on ClinicalTrials.gov