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NCT Number: NCT02464319

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

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)).

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Key information

Conditions

Primary Sjögren's Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

About this study

Each pSS patients (n=60) with Scores>=6 on ESSDAI 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, clinical and immunologic response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of a primary Sjögren´s Syndrome
  • ESSDAI score ≥ 6
  • Liver values above 1,5 ULN
  • Stable low dose systemic use of Glucocorticoids（<=7.5mg） in the last 4 weeks before begin with Study medication

Exclusion criteria

  • Secondary Sjögren's Syndrome
  • Pre-treatment with Cyclosporine A
  • Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimumab, other immunosuppressives
  • Infection
  • Neoplasia
  • Relevant cardiac, pulmonary, neurologic or psychiatric disease
  • Life-Vaccination within 4 weeks before begin with study medication
  • Pregnant or breast-feeding
  • Weight under 45kg or more than 80kg

Treatment and study plan

hrIL-2 active

Drug

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

Other names: Human recombinant IL-2

hrIL-2 placebo

Drug

1 million U doses of placebo s.c. injection active group: placebo group =1:1

Other names: placebo

Primary outcomes

  1. Examination of the therapeutic effects (improvement in ESSDAI) of low dose IL-2 in patients with primary Sjögren's Syndrome

    Time frame: 24 weeks

Secondary outcomes

  1. Immunological Responses

    Time frame: 0,12,24weeks

    Analysis regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells before and during IL-2 treatment. P values below 0.05 are considered statistically significant in this study

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Beijing ShuangLu Pharmaceutical Co., Ltd.
  • Monash University

Registry information

Official study title

Safety and Efficiency Study of Low-dose IL-2 Treatment in Primary Sjögren's Syndrome

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2015
Registry last updated
Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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