A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (Adalimumab [US]) and ABP 501 Compared With Continued Use of Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 425
- 试验地点
- 88
- 主要终点
- Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
研究概览
简要总结
Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.
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
- Double (Participant, Investigator)
盲法说明
Study is double-blind.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants has moderate to severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months and has stable disease for at least 2 months
- •Participants has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA) and static Physician's Global Assessment (sPGA) ≥ 3 at screening and at baseline
- •Participant has no known history of latent or active tuberculosis
排除标准
- •Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication induced psoriasis, or other skin conditions at the time of screening (eg, eczema) that would interfere with evaluations of the effect of investigational product of psoriasis
- •Participant has an active infection or history of infections
- •Participant has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment
- •Participant has received nonbiologic systemic psoriasis therapy within 4 weeks prior to enrollment
- •Participant has received ultraviolet (UV) A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks prior to enrollment
- •Participant has received topical psoriasis treatment within 2 weeks prior to enrollment
研究组 & 干预措施
Continued-use Group (Adalimumab)
Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.
干预措施: Adalimumab (Drug)
Switching Group (Adalimumab - ABP 501)
Participants will initially receive adalimumab until Week 10 during the lead-in period. Thereafter, starting from Week 12, participants will switch between ABP 501 and adalimumab Q2W with last dose of ABP 501 at Week 28.
干预措施: Adalimumab (Drug)
Switching Group (Adalimumab - ABP 501)
Participants will initially receive adalimumab until Week 10 during the lead-in period. Thereafter, starting from Week 12, participants will switch between ABP 501 and adalimumab Q2W with last dose of ABP 501 at Week 28.
干预措施: ABP 501 (Drug)
结局指标
主要结局
Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
时间窗: Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
Participants analyzed according to actual treatment received.
Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)
时间窗: Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
Participants analyzed according to treatment received.
次要结局
- Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)(Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose)
- Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)(Pre-dose at Week 12, Week 16, Week 20, and Week 28)
- PASI Percent Improvement From Baseline (Day 1) to Week 30(Baseline (Day 1) and Week 30)
- Number of Participants Achieving PASI 75 Response at Week 30(Baseline (Day 1) and Week 30)
- Number of Participants Achieving PASI 90 Response at Week 30(Baseline (Day 1) and Week 30)
- Number of Participants Achieving PASI 100 Response at Week 30(Baseline (Day 1) and Week 30)
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)(Baseline up to Week 32)
- Number of Participants Experiencing Events of Interest (EOI)(Baseline up to Week 32)
- Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization(Week 16, Week 20, Week 28, Week 30, and Week 32)