A Canadian Phase IV, Multicenter, Single-Arm Study To Evaluate the Effectiveness of Treatment With Brodalumab (SILIQ) in Psoriasis Patients With Inadequate Response to Their Current Biologic Agent Regimen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 11
- 主要终点
- Percentage of Participants Achieving Psoriasis Area and Severity Score (PASI) 100 Response at Week 26
研究概览
简要总结
This multicenter, prospective, observational, single-arm, 26-week study will evaluate the effectiveness, safety and tolerability of brodalumab subcutaneous injection in participants with psoriasis with inadequate response to their current biologic agent regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participant has enrolled in the brodalumab patient support program (PSP).
- •Participant has provided informed consent, using an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- •Confirmed diagnosis with moderate to severe plaque psoriasis.
- •On stable treatment with a biologic for a minimum of 12 weeks, and not having achieved adequate therapeutic response, as per the investigator's judgment, for example BSA of greater than or equal to (≥) 1% and physicians global assessment (PGA) of ≥
- •Participant must be able to understand and communicate with the investigator, as well as complete the study questionnaires, in one of the available and validated languages.
- •Participants participating in other observational studies or registries are permitted to enroll in this study at the same time.
排除标准
- •Receiving or has received any investigational drug (or is currently using an investigational device) within 30 days or 5 drug half-lives (whichever is longer) prior to receiving the first dose of brodalumab (Day 1).
- •Participant has a history of any psychiatric disorder or substance abuse that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- •Participant has previous history of suicidal ideation and/or behavior or report suicidal ideation and/or behavior during the study.
- •Presence of any other serious and/or uncontrolled medical condition that, in the opinion of the investigator, prohibits the participant from participating in the study.
- •Participant has a body mass index (BMI) greater than (>) 40 kilograms/square meter (kg/m^2) during the screening phase or during the study.
- •Any contraindication as per the product monograph: Brodalumab injection is contraindicated in participants with clinically significant hypersensitivity to brodalumab or to any of the excipients or component of the container. Brodalumab is contraindicated in participants with Crohn's disease.
研究组 & 干预措施
Brodalumab 210 mg Q2W
Participants will receive brodalumab 210 milligrams (mg) administered as 1 subcutaneous injection at Day 1 and at Weeks 1 and 2 followed by 210 mg every 2 weeks (Q2W) thereafter until Week 26.
干预措施: Brodalumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Psoriasis Area and Severity Score (PASI) 100 Response at Week 26
时间窗: Week 26
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). PASI 100 responders were defined as participants achieving 100% improvement at Week 26.
次要结局
- Percentage of Participants Achieving Static Physicians Global Assessment (sPGA) Score 0/1(Weeks 1, 2, 4, 16, and 26)
- Change From Baseline in Mean sPGA * Body Surface Area (BSA) Score at Weeks 1, 2, 4, 16, and 26(Baseline, Weeks 1, 2, 4, 16, and 26)
- Percentage of Participants Achieving PASI 75 and PASI 90(Weeks 1, 2, 4, 16, and 26)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Weeks 1, 2, 4, 16, and 26(Baseline, Weeks 1, 2, 4, 16, and 26)
- Change From Baseline in EuroQoL-5 Dimensional (EQ-5D) With Psoriasis Bolt-on (EQ-PSO) Score at Weeks 1, 2, 4, 16, and 26(Baseline, Weeks 1, 2, 4, 16, and 26)
- Number of Participants With Adverse Events (AEs)(Baseline (Week 0) up to end of treatment (Week 26))
- Time to Onset of Action(Baseline up to Week 26)
- Number of Participants Adhering to the Treatment(Baseline up to Week 26)
- Percentage of Participants Achieving PASI 100 at Weeks 1, 2, 4, and 16(Weeks 1, 2, 4, and 16)
- Change From Baseline in Psoriasis Symptoms Inventory (PSI) Score at Weeks 1, 2, 4, 16, and 26(Baseline, Weeks 1, 2, 4, 16, and 26)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 1, 2, 4, 16, and 26(Baseline, Weeks 1, 2, 4, 16, and 26)
- Percentage of Participants Achieving PASI 75, PASI 90, and PASI 100 at Week 16 and 26 According to the Last Biologic Agent That the Participant was Receiving Before Initiating Treatment With Brodalumab(Week 16 and 26)