NCT02749370已完成4 期
Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a PASI 75 Response at Week 12
研究概览
简要总结
To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).
详细描述
This is a multicenter, open-label, single-arm, phase 4, estimation study in adults with plaque psoriasis (PsO) who have failed apremilast. The study will consist of a screening period of up to 45 days, a 24-week treatment period with study visits every 4 weeks, and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for adults with plaque psoriasis.
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
- •Subject has provided informed consent prior to initiation of any study specific activities/procedures
- •Male or female subject is ≥ 18 years of age at time of screening
- •Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator
- •Subject has moderate to severe plaque psoriasis (PsO) with involved body surface area (BSA) ≥ 10%, psoriasis area and severity index (PASI) ≥ 10 and static physician's global assessment (sPGA) ≥ 3 at screening and baseline
- •Subject is currently receiving treatment with apremilast for moderate to severe plaque PsO or subject has discontinued treatment with apremilast for PsO within the past 3 months prior to screening
- •Subject has failed therapy with apremilast for moderate to severe plaque PsO defined as either (1) failure to achieve adequate clinical response in the opinion of the investigator, (2) loss of adequate clinical response in the opinion of the investigator or (3) intolerability to apremilast in the opinion of the investigator
- •Subject has received at least 4 weeks of apremilast treatment for moderate to severe plaque PsO (this only applies for subjects who are qualifying by failure to achieve adequate clinical response or loss of adequate clinical response, this does not apply for subjects who are qualifying by intolerability to apremilast)
- •Subject has not had significant known weight increase or decrease (≥ 10%) during apremilast treatment
- •Subject is < 264 lbs at screening and baseline -Subject has a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody
- •Subject has no known history of tuberculosis.
排除标准
- •Skin disease related
- •Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions at the time of the screening visit (for example, eczema) that would interfere with evaluations of the effect of investigational product on PsO.
- •Other Medical Conditions
- •Subject has one or more significant concurrent medical conditions per investigator judgment, including the following
- •Poorly controlled diabetes
- •Chronic kidney disease stage IIIb, IV, or V
- •Symptomatic heart failure (New York Heart Association class II, III, or IV)
- •Myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
- •Uncontrolled hypertension
- •Severe chronic pulmonary disease (eg, requiring oxygen therapy)
- •Multiple sclerosis or any other demyelinating disease
- •Liver disease
- •Major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis (for example, systemic lupus erythematosus with the exception of secondary Sjogren's syndrome)
- •Subject has active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, Merkel cell carcinoma or history of cancer (other than fully resected and surgically cured cutaneous basal cell and squamous cell carcinoma) within 5 years before the first dose of investigational product.
研究组 & 干预措施
Etanercept
Experimental
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
干预措施: Etanercept (Drug)
结局指标
主要结局
Percentage of Participants With a PASI 75 Response at Week 12
时间窗: Baseline and week 12
A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. 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 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.
次要结局
- Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline(Baseline and weeks 4, 8, 12, 16, 20, and 24)
- PSI "Redness of Skin Lesions" Component Score at Each Visit(Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With a PASI 50 Response at Each Visit(Baseline and weeks 4, 8, 12, 16, 20, and 24)
- Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit(Baseline and weeks 4, 8, 12, 16, 20, and 24)
- Static Physician Global Assessment (sPGA) at Each Visit(Weeks 4, 8, 12, 16, 20, and 24)
- Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)(Baseline and weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With a PASI 75 Response at Each Visit(Baseline and weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With a PASI 90 Response at Each Visit(Baseline and weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline(Baseline and weeks 4, 8, 12, 16, 20, and 24)
- Patient Assessment of Treatment Satisfaction at Week 12(Week 12)
- PSI "Cracking of Skin Lesions" Component Score at Each Visit(Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)
- Psoriasis Symptom Inventory (PSI) Total Score at Each Visit(Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)
- PSI "Scaling of Skin Lesions" Component Score at Each Visit(Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)
- Number of Participants With Adverse Events(From first dose of etanercept to 30 days after last dose, up to 28 weeks.)
- PSI "Itch From Psoriasis" Component Score at Each Visit(Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)
- PSI "Burning of Skin Lesions" Component Score at Each Visit(Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)
- PSI "Stinging of Skin Lesions" Component Score at Each Visit(Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)
- Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24(Baseline and weeks 12 and 24)
- PSI "Flaking of Skin Lesions" Component Score at Each Visit(Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)
- PSI "Pain From Skin Lesions" Component Score at Each Visit(Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)
- Patient Assessment of Treatment Satisfaction at Week 24(Week 24)
研究者
研究点 (1)
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