The study aims to evaluate the clinical efficacy of oral apremilast 30 mg BID compared with placebo in Chinese participants with moderate to severe PsO
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
203
Oral tablet
Oral tablet
Peking University First Hospital
Beijing, Beijing Municipality, China
Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
Time frame: Week 16
Number of Participants Achieving a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) and with ≥ 2-point Reduction From Baseline at Week 16
Time frame: Baseline and Week 16
Number of Participants Achieving ≥ 4-point Reduction (Improvement) From Baseline in the Whole Body Itch Scale (NRS) Score at Week 16
Time frame: Baseline and Week 16
Number of Participants with Baseline Scalp Physician's Globa Assesment (ScPGA) of ≥ 2 Achieving a Clear (0) or Almost Clear (1) ScPGA and with ≥ 2-point Reduction From Baseline and at Week 16
Time frame: Baseline and Week 16
Percent Change of PASI From Baseline at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in Affected Body Surface Area (BSA) at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
Time frame: Baseline and Week 16
Number of Participants who Have a Baseline Scalp Itch NRS ≥ 4 and Achieving ≥ 4-point Reduction (Improvement) From Baseline in Scalp Itch NRS at Week 16
Time frame: Baseline and Week 16
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
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Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Nanyang First Peoples Hospital
Nanyang, Henan, China
Yichang Central Peoples Hospital
Yichang, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Changshu No2 Peoples Hospital
Suzhou, Jiangsu, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, China
...and 11 more locations
TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs.
Time frame: Baseline to Week 52
Plasma Concentration of Apremilast
Time frame: Baseline to Week 16