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.
Parallel
ICP-488 Tablets
DrugSpecified dose on specified days
ICP-488 Placebo
DrugSpecified dose on specified days
Change from baseline in EULAR sjögren's syndrome disease activity index（ESSDAI ) at Week 24
Change from baseline in ESSDAI at each scheduled visit during the 24-week treatment period.
Percentage (%) of participants achieving a reduction from baseline in ESSDAI of ≥3 points at each scheduled visit during the 24-week treatment period.
Percentage (%) of participants with ESSDAI <5 at each scheduled visit during the 24-week treatment period.
Change from baseline in ESSPRI at each scheduled visit during the 24-week treatment period.
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This trial is not recruiting at the moment. You can still explore other options:
