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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02464319
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : March 15, 2018
Monash University
Beijing ShuangLu Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Zhanguo Li, Peking University People's Hospital

Brief 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)).

Condition or disease Intervention/treatment Phase
Primary Sjögren's Syndrome Drug: hrIL-2 active Drug: hrIL-2 placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficiency Study of Low-dose IL-2 Treatment in Primary Sjögren's Syndrome
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Experimental: hrIL-2 active
Intervention:Add hrIL-2 according to the protocol to original treatment. HrIL-2 active: 1 million U doses of human recombinant interleukin-2 s.c. injection
Drug: hrIL-2 active
1 million U doses of human recombinant interleukin-2 s.c. injection active group: placebo group =1:1
Other Name: Human recombinant IL-2

Placebo Comparator: Placebo Comparator: hrIL-2 placebo
1 million U doses of placebo s.c. injection
Drug: hrIL-2 placebo
1 million U doses of placebo s.c. injection active group: placebo group =1:1
Other Name: placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02464319

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China, Beijing
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Monash University
Beijing ShuangLu Pharmaceutical Co., Ltd.
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Principal Investigator: Zhanguo Li, MD, PhD Peking University Institute of Rheumatology and Immunology
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Responsible Party: Zhanguo Li, Chief of Department of Rheumatology and Immunology,Peking University People's Hospital, Peking University People's Hospital Identifier: NCT02464319    
Other Study ID Numbers: hrIL-2-SS1
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases