NCT03721172已完成3 期
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Mild to Moderate Plaque 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
- 595
- 试验地点
- 64
- 主要终点
- Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase
研究概览
简要总结
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis.
Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.
详细描述
The study will consist of four phases:
- Screening Phase - up to 35 days
- Double-blind Placebo-controlled Phase - Weeks 0 to 16
- Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID.
- Apremilast Extension Phase - Weeks 16 to 32
- All subjects will be switched to (or continue with) apremilast 30 mg BID. All subjects will maintain this dosing through Week 32.
- Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).
- •Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
- •Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.
- •Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
- •Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
- •Subject must meet laboratory criteria.
- •Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.
排除标准
- •The presence of any of the following will exclude a subject from enrollment:
- •Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- •Subjects has any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- •Subject has hepatitis B surface antigen positive at Screening.
- •Subject has active tuberculosis (TB) or a history of incompletely treated TB.
- •Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
- •Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
- •Subject has prior history of suicide attempt at any time in the subject's life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
- •Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial.
- •Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
- •Subject had prior treatment with apremilast.
研究组 & 干预措施
Placebo-controlled Phase:
Experimental
Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).
干预措施: Placebo (Other)
Placebo-controlled Phase: Apremilast 30 mg
Experimental
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
干预措施: Apremilast (Drug)
Extension Phase: Apremilast 30 mg
Experimental
Eligible participants who completed the placebocontrolled phase entered the extension phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).
干预措施: Apremilast (Drug)
结局指标
主要结局
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase
时间窗: Baseline and Week 16 of the placebo-controlled phase
The sPGA is a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 =severe. Scores incorporate an assessment by the Investigator of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation. An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with at least a 2-point reduction from baseline at Week 16.
次要结局
- Percentage of Participants With a ≥ 75 Percent (%) Improvement From Baseline in Affected Body Surface Area (BSA) at Week 16(Baseline and Week 16 of the placebo-controlled phase)
- Change From Baseline in Percentage of Affected BSA at Week 16(Baseline and Week 16 of the placebo-controlled phase)
- Percentage of Participants Who Achieved BSA ≤ 3% for Participants With Baseline Affected BSA > 3% at Week 16(Baseline and Week 16 of the placebo-controlled phase)
- Percentage of Participants With ≥ 4-point Reduction From Baseline in Whole Body Itch Numeric Rating Scale (NRS) Score at Week 16 Who Had Baseline Whole Body Itch NRS ≥ 4(Baseline and Week 16 of the placebo-controlled phase)
- Change From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 16(Baseline and Week 16 of the placebo-controlled phase)
- Percentage of Participants With a Scalp Physician Global Assessment (ScPGA) Response at Week 16 Among Participants With Baseline scPGA Score ≥ 2 at Week 16(Baseline and Week 16 of the placebo-controlled phase)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16(Baseline and Week 16 of the placebo-controlled phase)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Placebo: Day 1 to Week 16; Apremilast Day 1 to a maximum of Week 32 (plus 4 week safety follow-up))
研究者
研究点 (64)
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