Overview
Primary Objective:
To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity.
Secondary Objectives:
- To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS.
- To evaluate the safety and tolerability of dazodalibep in participants with SS
Description
Acquired from Horizon in 2024.
Eligibility
Key Inclusion Criteria:
- Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.
- Have an European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of >= 5 despite symptomatic or local therapy at screening.
- Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).
Key Exclusion Criteria:
- Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
- Active malignancy or history of malignancy within the last 5 years, except in situ carcinoma of cervix treated with apparent success with curative therapy > 12 months prior to screening OR cutaneous basal cell carcinoma following presumed curative therapy.
- Individuals with any severe or life-threatening cardiovascular (including vasculitis)