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

Phase 2

Completed

• Conditions: Primary Sjögren's Syndrome
• Interventions: Drug: hrIL-2 active; Drug: hrIL-2 placebo

• Registration Number: NCT02464319
• Lead Sponsor: 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)).

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.

Study Timeline

• Study First Submitted: 2015-05-30
• Study Start: 2015-06-01
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Primary Completion: 2017-03-31
• Study Completion: 2017-08-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: hrIL-2 active	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
Placebo Comparator: hrIL-2 placebo	hrIL-2 placebo	1 million U doses of placebo s.c. injection

Primary Outcome Measures

Name	Time	Method
Examination of the therapeutic effects (improvement in ESSDAI) of low dose IL-2 in patients with primary Sjögren's Syndrome	24 weeks

Secondary Outcome Measures

Name	Time	Method
Immunological Responses	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

Trial Locations

Locations (1)

Department of Rheumatology and Immunology, Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China