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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Specified dose on specified days
Specified dose on specified days
Peking
Change from baseline in EULAR sjögren's syndrome disease activity index(ESSDAI ) at Week 24
Time frame: Baseline, Week 24
Change from baseline in ESSDAI at each scheduled visit during the 24-week treatment period.
Time frame: Baseline, Week 24
Percentage (%) of participants achieving a reduction from baseline in ESSDAI of ≥3 points at each scheduled visit during the 24-week treatment period.
Time frame: Baseline, Week 24
Percentage (%) of participants with ESSDAI <5 at each scheduled visit during the 24-week treatment period.
Time frame: Baseline, Week 24
Change from baseline in ESSPRI at each scheduled visit during the 24-week treatment period.
Time frame: Baseline, Week 24
Percentage (%) of participants achieving a reduction from baseline in ESSPRI of ≥1 point or 15% at each scheduled visit during the 24-week treatment period.
Time frame: Baseline, Week 24
Treatment-emergent adverse events.
Time frame: Through study completion, an average of 1 year
Incidence of clinically significant abnormalities in laboratory test results, electrocardiograms (ECGs), vital signs, etc., and changes from baseline.
Time frame: Through study completion, an average of 1 year
Maximum Concentration at Steady State(Cmax,ss)
Time frame: Through study completion, an average of 1 year
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Beijing, Beijing Municipality, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China
"Southwest Hospital, Army Medical University (The First Hospital Affiliated to Army Medical University)"
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
...and 12 more locations
Steady-State Time to Maximum
Time frame: Through study completion, an average of 1 year
Area under the curve (AUC)
Time frame: Through study completion, an average of 1 year