This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in subjects with cutaneous lupus erythematosus (CLE).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
Patients will receive ICP-488 orally as per the protocol
Patients will receive ICP-488 orally as per the protocol
Patients will receive ICP-488 Placebo orally as per the protocol.
The percentage change of Cutaneous lupus erythematosus disease area and severity index-activity(CLASI-A) relative to the baseline at week 16.
Time frame: All the subjects completed the 16-week assessment.
At each visit, the proportion of subjects whose CLASI-A score improved by ≥50% compared to the baseline value (CLASI-50).
Time frame: From baseline to week 28
The proportion of subjects with disease improvement as defined by a reduction of ≥4 points relative to the baseline value of CLASI-A (CLASI ≥ 4)at each visit.
Time frame: From baseline to week 28
The average change of the CLASI-A score from the baseline value at each visit.
Time frame: From baseline to week 28
The percentage change of CLASI-A relative to the baseline at each visit.
Time frame: From baseline to week 28
Adverse events that occurred during treatment.
Time frame: From baseline to week 28
The incidence of clinical abnormalities such as laboratory test results, electrocardiogram (ECG), and vital signs, and the changes relative to the baseline.
Time frame: From baseline to week 28
Maximum Concentration at Steady State(Cmax,ss)
Time frame: From baseline to week 12
Steady-State Time to Maximum
Time frame: From baseline to week 12
Area under the curve (AUC)
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Dongguan people's hospital
Dongguan, Guangdong, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
...and 16 more locations
Time frame: From baseline to week 12