A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's Syndrome
Status:
Completed
Trial end date:
2017-08-31
Target enrollment:
Participant gender:
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)).
Phase:
Phase 2
Details
Lead Sponsor:
Peking University People's Hospital
Collaborators:
Beijing ShuangLu Pharmaceutical Co., Ltd. Monash University