A 16-week, Single Arm, Multicenter Study for the Assessment of Efficacy and Safety of Secukinumab in aduLt Patients With Moderate to Severe plaquE Psoriasis in Turkish Population
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Percentage of PASI 90 responder patients at Week 16 as compared to baseline
研究概览
简要总结
Secukinumab targets a different interleukin and has potential to be used as alternative to existing treatments. This study will provide clinical data with respect to efficacy through Psoriasis Area and Severity Index (PASI) at 16 weeks, safety/tolerability of secukinumab and evaluate the impact of the treatment on quality of life and work productivity in subjects with moderate to severe plaque psoriasis in the Turkish population.
详细描述
To demonstrate the efficacy of secukinumab in subjects with moderate to severe plaque psoriasis based on the percentage of PASI 90 responder patients at Week 16 as compared to baseline Evaluation of onset of efficacy measured by the percentage of patient achieving PASI 75 and PASI 90 at week 4 The efficacy of treatment using Investigator's Global Assessment modified 2011 (IGA mod 2011) at week 4 and week 16 Work productivity (measured with WPAI-PSO) at Week 16 Changes in quality of life measured with the Dermatology Life Quality Index (DLQI) at Week 16 Health assessment questionnaire -Disability index (HAQ-DI) in patients with psoriatic arthritis (PsA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator
- •Diagnosis of chronic plaque psoriasis for at least 6 months before enrollment
- •Patients who were evaluated as candidates for systemic therapy, defined as having psoriasis intolerant or /and inadequately controlled by: topical treatment (including topical corticosteroid) and/or phototherapy and/or any previous systemic treatment for psoriasis or any previous treatment with biologic agents
排除标准
- •Forms of psoriasis other than plaque psoriasis
- •Drug-induced psoriasis
- •Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA
- •Pregnant or nursing (lactating) women
- •Active ongoing inflammatory diseases other than psoriasis or psoriatic arthritis that might confound the evaluation of the benefit of secukinumab
- •Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions)
- •Pre-existing or recent-onset central or peripheral nervous system demyelinating disorders
- •Significant medical problems, including but not limited to the following: uncontrolled hypertension, congestive heart failure
- •Active systemic infections during the 2 weeks prior to enrollment
- •History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection
- •Past medical history record of, or current infection with, human immunodeficiency virus (HIV), hepatitis B or hepatitis C prior to enrollment
- •History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years
- •History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to enrollment
- •Plans for administration of live vaccines during the study period or in the 6 weeks prior to enrollment
- •Not willing to limit UV light exposure
研究组 & 干预措施
"Secukinumab" "Cosentyx TM"
"Secukinumab" "Cosentyx TM" 150 mg PFS (pre-filled syringe) containing for solution for s.c. injection will be applied as 2 units (300 mg dosage) per patient at each visit.
First month: 300 mg injections/week, 4 weeks Starting from 4th week until Week 16, one injection/month
干预措施: "Secukinumab" "Cosentyx TM" (Drug)
结局指标
主要结局
Percentage of PASI 90 responder patients at Week 16 as compared to baseline
时间窗: 16 week
The primary endpoint has been chosen as percentage of PASI 90 responder patients. PASI 90 is accepted as clear or almost clear of psoriatic lesions which are the ultimate goal of treatment in plaque psoriasis.
次要结局
- The efficacy of treatment using Investigator's Global Assessment modified 2011 (IGA mod 2011) at week 4 and week 16(4 and 16 week)
- Changes in quality of life measured with the Dermatology Life Quality Index (DLQI) at Week 16(16 week)
- Evaluation of onset of efficacy measured by the percentage of patient achieving PASI 75 and PASI 90 at week 4(4 week)
- Health assessment questionnaire -Disability index (HAQ-DI) in patients with psoriatic arthritis (PsA)(16 week)
- Work productivity (measured with WPAI-PSO) at Week 16(16 week)