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

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2017-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Primary Sjögren's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

hrIL-2 active

Intervention Type DRUG

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

Placebo Comparator: hrIL-2 placebo

1 million U doses of placebo s.c. injection

Group Type PLACEBO_COMPARATOR

hrIL-2 placebo

Intervention Type DRUG

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

Interventions

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hrIL-2 active

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

Intervention Type DRUG

hrIL-2 placebo

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

Intervention Type DRUG

Other Intervention Names

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Human recombinant IL-2 placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No