Recruitment Complete
Sponsor ID
20200250
A study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants with Moderate to Severe Plaque-type Psoriasis (PsO)ESSENCE
Study Details
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
Protocol Summary
Primary Outcome Measures
Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
Timeframe: Week 16
Secondary Outcome Measures
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
Timeframe: 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
Timeframe: 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
Timeframe: Baseline and Week 16
Percent Change of PASI From Baseline at Week 16
Timeframe: Baseline and Week 16
Percent Change From Baseline in Affected Body Surface Area (BSA) at Week 16
Timeframe: Baseline and Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
Timeframe: 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
Timeframe: Baseline and Week 16
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Baseline to Week 52
Plasma Concentration of Apremilast
Timeframe: Baseline to Week 16
Locations
Location
Peking University First Hospital
Beijing, Beijing, China, 100034
Status
Recruiting
Location
Shanghai Skin Disease Hospital
Shanghai, Shanghai, China, 200443
Status
Recruiting
Location
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China, 330000
Status
Recruiting
Location
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Status
Recruiting
Location
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Status
Recruiting
Location
Wuxi Peoples Hospital
Wuxi, Jiangsu, China, 241023
Status
Recruiting
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