A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 465
- 试验地点
- 79
- 主要终点
- PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab
研究概览
简要总结
The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.
详细描述
The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment.
The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.
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
- •Men or women at least 18 years of age at time of screening
- •Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization
- •Moderate to severe psoriasis as defined at baseline by:
- •PASI score of 12 or greater
- •Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and,
- •Body Surface Area affected by plaque-type psoriasis of 10% or greater
- •Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.
排除标准
- •Forms of psoriasis other than chronic plaque-type
- •Drug-induced psoriasis
- •Ongoing use of prohibited psoriasis treatments
- •Previous exposure to adalimumab
- •Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with adalimumab
- •Other In-/Exclusion criteria may apply
研究组 & 干预措施
GP2017 Adalimumab
Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.
干预措施: GP2017 Adalimumab (Drug)
Humira ® Adalimumab
Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.
干预措施: Humira ® Adalimumab (Drug)
结局指标
主要结局
PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab
时间窗: At Week 16 only
The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.
次要结局
- Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)(Baseline to Week 16)
- PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates(At Week 17 only)
- Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)(Baseline to Week 16)
- DLQI(At Week 51 only)
- PASI 50, PASI75, PASI 90 and PASI100 Response Rates(At Week 51 only)
- ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51(At Week 51 only)
- IGA Response Rate(At Week 51 only)
- ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17(At Week 17 only)