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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02464319

Enrollment

Registered

2015-06-08

Start date

2015-06-01

Completion date

2017-08-31

Last updated

2018-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjögren's Syndrome

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.

Interventions

DRUGhrIL-2 active

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

DRUGhrIL-2 placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026