Long Term Clear Skin Maintenance Treatment Optimization in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Multicenter, Open-label With Blinded-assessment, Comparative, 52 Week Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg s.c.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16,487
- 试验地点
- 201
- 主要终点
- Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24
研究概览
简要总结
To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.
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)
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
- •Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and candidate for systemic therapy.
- •Moderate to severe psoriasis at Baseline as evidenced by:
- •PASI ≥ 10 and
- •IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and
- •BSA affected by plaque-type psoriasis of ≥ 10%.
排除标准
- •History of exposure to any biologic drug taken for the treatment of chronic plaque psoriasis or any other indication including but not limited to anti-tumor necrosis factor (TNF) alpha, anti interleukin (IL)12/23, or any anti-IL 17A or IL 17A receptor (IL 17AR) antibody.
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- •Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis).
- •Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
- •Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy).
- •Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study drug.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study drug and for 16 weeks after stopping study drug.
- •Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy.
- •Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
研究组 & 干预措施
Secukinumab 300mg in PASI 90 responders (longer intervals)
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 6 weeks.
干预措施: Secukinumab (Biological)
Secukinumab 300mg in PASI 75-90 responders (every 4 weeks)
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks will be treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.
干预措施: Secukinumab (Biological)
Secukinumab 300mg in PASI 75-90 responders (shorter intervals)
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to <90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 2 weeks.
干预措施: Secukinumab (Biological)
Secukinumab 300mg in PASI 90 responders (every 4 weeks)
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.
干预措施: Secukinumab (Biological)
结局指标
主要结局
Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24
时间窗: Week 52
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
次要结局
- Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24(Week 52)
- PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24(week 52)
- Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24(Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52)
- Change From Baseline in DLQI in Participants With a PASI 90 Response at Week 24(Baseline, Week 52)
- Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI 90 Response at Week 24(Baseline, Week 52)
- PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24(Week 52)
- Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24(Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52)
- Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24(Baseline, Week 52)
- Change From Baseline in DLQI in Participants With a PASI Response of ≥75 to <90 at Week 24(Baseline, Week 52)
- Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24(Baseline, Week 52)
- Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) in Participants With a PASI 90 Response at Week 24(Baseline, Week 52)
- Change From Baseline in the EQ-5D VAS in Participants With a PASI Response of ≥75 to <90 at Week 24(Baseline, Week 52)
- Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of ≥75 to <90 at Week 24(Baseline, Week 52)
- Change From Baseline in the EQ-5D Utility Index (Germany, United Kingdom (UK)) in Participants With a PASI 90 Response at Week 24(Baseline, Week 52)
- Change From Baseline in the EQ-5D Utility Index (Germany, UK) in Participants With a PASI Response of ≥75 to <90 at Week 24(Baseline, Week 52)