Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome
Status:
Not yet recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
Summary
The ANISE-II study is a randomized, double-blind, placebo-controlled phase IIa
proof-of-concept trial. Thirty patients with primary Sjögren's syndrome (pSS) are randomized
in a 2:1 ratio to either anifrolumab or placebo treatment for 24 weeks. Main inclusion
criteria are fulfilment of the ACR/EULAR classification criteria for pSS, disease duration of
≤10 years, and an ESSDAI and/or ESSPRI of ≥5 (at least 50% of patients need to fulfil the
ESSDAI ≥5 criterion). The primary outcome measure is Composite of Relevant Endpoints for
Sjögren's Syndrome (CRESS) response at week 24.