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
NOT_YET_RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGXuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGChongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGDongguan people's hospital
Dongguan, Guangdong, China
RECRUITINGDermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITING...and 17 more locations
Time frame: From baseline to week 12