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

Primary Sjögren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464319
• Other study ID #: hrIL-2-SS1
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2015
• Last updated: March 13, 2018
• Start date: June 1, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: March 2018
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Sjögren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Department of Rheumatology and Immunology, Peking University People's Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing ShuangLu Pharmaceutical Co., Ltd., Monash University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of the therapeutic effects (improvement in ESSDAI) of low dose IL-2 in patients with primary Sjögren's Syndrome		24 weeks
Secondary	Immunological Responses	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	0,12,24weeks