A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Etanercept (GP2015) and Enbrel® 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
- 531
- 试验地点
- 6
- 主要终点
- PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept
研究概览
简要总结
The purpose of this study is to demonstrate equivalent efficacy of GP2015 and Enbrel® in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 response rate at Week 12.
详细描述
The purpose of this confirmatory safety and efficacy study (GP15-302) was to demonstrate equivalence in efficacy and similarity in safety and immunogenicity of GP2015 and Enbrel (EU-authorized) in patients with moderate to severe chronic plaque-type psoriasis and to evaluate the effects of repeated switching between GP2015 and Enbrel on efficacy, overall safety, and immunogenicity. Since only EU-authorized Enbrel was utilized in this study, the use of the term "Enbrel" throughout this report describes EU-authorized Enbrel only.
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 baseline
- •Moderate to severe psoriasis as defined at baseline by:
- •PASI score of 10 or greater and,
- •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 treatments
- •Previous exposure to etanercept
- •Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with etanercept
- •Other In-/Exclusion criteria may apply
研究组 & 干预措施
GP2015 Etanercept
Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
干预措施: GP2015 Etanercept (Drug)
Enbrel ® Etanercept
Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
干预措施: Enbrel (Drug)
结局指标
主要结局
PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept
时间窗: Week 12
The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
次要结局
- Percent Change From Baseline in PASI Score up to Week 12(12 weeks)
- PASI 50, 75 and 90 Response Rates(Week12)
- Injection Site Reactions(Week52)
- Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept(Week 52)