This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in participants with primary Sjögren's syndrome (pSjS).
Aged 18 to 70 years inclusive.
The disease duration (from the date of diagnosis) prior to screening shall be at least 24 weeks and no more than 5 years..
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at screening is ≥ 5.
At screening, the stimulated whole salivary flow (SWSF) ≥ 0.05 mL/min OR unstimulated whole salivary flow (UWSF) ≥ 0.01 mL/min.
SjS secondary to other systemic autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis).
Other autoimmune or inflammatory diseases that could interfere with the assessment of treatment response in SjS.
Presence of any other medical condition associated with SjS symptoms.
Participants with a history of any clinically significant disease other than pSjS.