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)
- Registration Number
- NCT06122649
- Lead Sponsor
- Amgen
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 203
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo-controlled Treatment Phas apremilast Participants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks. Placebo-controlled Treatment Phas Placebo Participants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks. Active Treatment Phase apremilast Participants who received placebo during the placebo-controlled treatment phase will receive apremilast BID for 36 weeks. Participants who took apremilast will continue receiving it BID for 36 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 Week 16
- Secondary Outcome Measures
Name Time Method Number of Participants Achieving ≥ 4-point Reduction (Improvement) From Baseline in the Whole Body Itch Scale (NRS) Score at Week 16 Baseline and Week 16 Percent Change From Baseline in Affected Body Surface Area (BSA) at Week 16 Baseline and Week 16 Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Baseline to Week 52 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.
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 Baseline and Week 16 Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 Baseline and Week 16 Plasma Concentration of Apremilast Baseline to 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 Baseline and Week 16 Percent Change of PASI From Baseline at Week 16 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 Baseline and Week 16
Trial Locations
- Locations (21)
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, 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
Dermatology Hospital of Jiangxi Province
🇨🇳Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Shandong Provincial Hospital For Skin Diseases,Shandong First Medical University
🇨🇳Jinan, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai Skin Disease Hospital
🇨🇳Shanghai, Shanghai, China
Chengdu Second Peoples Hospital
🇨🇳Chengdu, Sichuan, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Sichuan, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Peoples Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Urumqi, Xinjiang, China
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China