Clinical trial NCT02464319: A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's Syndrome
Official title: Safety and Efficiency Study of Low-dose IL-2 Treatment in Primary Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Sjögren's Syndrome
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Monash University
name: Beijing ShuangLu Pharmaceutical Co., Ltd.
First posted: 2015-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Examination of the therapeutic effects (improvement in ESSDAI) of low dose IL-2 in patients with primary Sjögren's Syndrome
timeFrame: 24 weeks
Secondary outcomes:
measure: Immunological Responses
timeFrame: 0,12,24weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Rheumatology and Immunology, Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University Institute of Rheumatology and Immunology
name: Zhanguo Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: He J, Chen J, Miao M, Zhang R, Cheng G, Wang Y, Feng R, Huang B, Luan H, Jia Y, Jin Y, Zhang X, Shao M, Wang Y, Zhang X, Li J, Zhao X, Wang H, Liu T, Xiao X, Zhang X, Su Y, Mu R, Ye H, Li R, Liu X, Liu Y, Li C, Liu H, Hu F, Guo J, Liu W, Zhang WB, Jacob A, Ambrus JL Jr, Ding C, Yu D, Sun X, Li Z. Efficacy and Safety of Low-Dose Interleukin 2 for Primary Sjogren Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241451. doi: 10.1001/jamanetworkopen.2022.41451.