NCT06122649已完成3 期
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Apremilast 30 mg Twice Daily in Chinese Subjects With Moderate to Severe Plaque-type Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 203
- 试验地点
- 41
- 主要终点
- Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese participants aged ≥
- •Diagnosis of chronic, stable moderate to severe plaque PsO for ≥ 12 months before screening. The participant must have sPGA score ≥ 3, PASI score ≥ 12, and BSA involvement ≥ 10% at both screening and baseline (week 0).
- •Participant is a candidate for phototherapy and/or systemic therapy.
排除标准
- •Psoriasis flare within 4 weeks of screening.
- •Evidence of skin conditions that would interfere with evaluations of the effect of study medication on psoriasis.
- •Prior medical history of suicide attempt at any time in the participant's lifetime before screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- •Participant has a malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years.
- •Active tuberculosis or a history of incompletely treated tuberculosis.
- •History of human immunodeficiency virus (HIV) infection.
- •Prior treatment with apremilast.
- •Female participants of childbearing potential unwilling to use protocol specified method of contraception.
- •Female participants who are breastfeeding or who plan to breastfeed.
- •Female participants planning to become pregnant.
研究组 & 干预措施
Placebo-controlled Treatment Phas
Experimental
Participants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks.
干预措施: apremilast (Drug)
Placebo-controlled Treatment Phas
Experimental
Participants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks.
干预措施: Placebo (Drug)
Active Treatment Phase
Experimental
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.
干预措施: apremilast (Drug)
结局指标
主要结局
Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
时间窗: Week 16
次要结局
- 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)
- 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)
研究者
研究点 (41)
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