A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared With 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
- 350
- 试验地点
- 4
- 主要终点
- Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
研究概览
简要总结
The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥ 18 and ≤ 75 years of age at time of screening
- •Stable moderate to severe plaque psoriasis for at least 6 months before baseline
- •Moderate to severe psoriasis defined at screening and baseline by:
- •Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater, and static physician's global assessment score of 3 or greater
- •No known history of active tuberculosis
- •Subject is a candidate for systemic therapy or phototherapy procedures
- •Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy
排除标准
- •Forms of psoriasis or other skin conditions at the time of the screening visit (eg, eczema)
- •Ongoing use of prohibited treatments
- •Prior use of 2 or more biologics for treatment of psoriasis
- •Previous receipt of adalimumab or a biosimilar of adalimumab
- •Other Inclusion/Exclusion criteria may apply
研究组 & 干预措施
ABP 501
Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.
Participants with a PASI 50 response at week 16 continued to receive 40 mg APB 501 until week 48.
干预措施: ABP 501 (Biological)
Adalimumab
Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.
At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to ABP 501 until week 48.
干预措施: Adalimumab (Biological)
结局指标
主要结局
Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
时间窗: Baseline and Week 16
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
次要结局
- Percentage of Participants With a PASI 75 Response at Week 50(Baseline and week 50)
- Percent Improvement From Baseline in PASI at Week 50(Baseline and week 50)
- Percentage of Participants With a sPGA Response at Week 32(Week 32)
- Percentage of Participants With a PASI 75 Response at Week 16(Baseline and Week 16)
- Percentage of Participants With a PASI 75 Response at Week 32(Baseline and week 32)
- Percent Improvement From Baseline in PASI at Week 32(Baseline and week 32)
- Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16(Week 16)
- Percentage of Participants With a sPGA Response at Week 50(Week 50)
- Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16(Baseline and Week 16)
- Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32(Baseline and week 32)
- Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50(Baseline and week 50)
- Number of Participants With Adverse Events(From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.)
- Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab(For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.)