A Phase 4 Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 210
- 试验地点
- 30
- 主要终点
- Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24
研究概览
简要总结
The primary objective is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in subjects who have not previously received systemic treatment for psoriasis.
Fumaric acid esters have been selected as the comparator because it is an established systemic treatment of psoriasis in Germany.
详细描述
A 24-week, randomised, open-label, active-controlled, parallel group, multi-centre trial with investigator-blinded efficacy assessments
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
- Single (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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Brodalumab
Kyntheum® (brodalumab)
pre-filled syringe 210 mg/1.5 mL solution for subcutaneous injections.
First 3 injections are administered weekly, and hereafter every two weeks (Q2W).
干预措施: Brodalumab (Biological)
Fumaric acid esters
Fumaderm® initial dose tablets (30 mg dimethyl fumarate, 67 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt)
Fumaderm® tablets (120 mg dimethyl fumarate, 87 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt)
Fumaderm® tablets are administered orally up to 3 times daily in accordance with the dosing scheme in the label.
干预措施: Fumaric acid esters (Drug)
结局指标
主要结局
Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24
时间窗: Baseline to Week 24
The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).
Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at Week 24
时间窗: Baseline to Week 24
sPGA is a 6-point scale that represents the average lesion severity on the trunk and limbs. The assessment is based on the condition of the disease at the time of evaluation. Static Physician's Global Assessment is a scale ranging rom 0 (clear skin) to 5 (severe disease).
次要结局
- Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1)(Week 24)
- Number of Symptom-free Days From Randomisation to Week 24(Baseline to Week 24)
- Burden of Symptoms(Baseline to Week 24)
- Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at Week 24(Baseline to Week 24)
- Change From Baseline at Week 24 in PASI Score(Baseline to Week 24)
- DLQI Total Score of 0 or 1 at Week 24(Week 24)
- Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at Week 24(Baseline to Week 24)
- Percent Change From Baseline in PASI Score at Week 24(Baseline to Week 24)
- Change From Baseline at Week 24 in Affected Body Surface Area (BSA)(Baseline to Week 24)
- PSI Total Score of 0 at Week 24(Week 24)
- Change From Baseline at Week 24 in Dermatology Life Quality Index (DLQI) Total Score(Baseline to Week 24)