Bimzelx (Bimekizumab) For The Treatment Of Adult Onset Pityriasis Rubra Pilaris: A Single Arm, Open Label, Exploratory Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of patients with ≥ 75% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 24 weeks
研究概览
简要总结
The purpose of this study is to valuate the clinical efficacy of Bimzelx therapy in adults with Pityriasis Rubra Pilaris.
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
- •Clinical and/or histopathological diagnosis of PRP
- •Candidate for systemic therapy (PASI ≥ 10)
- •Body surface area of involvement ≥ 10%
- •Good general health as confirmed by medical history
- •Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
- •Patients who read and sign an approved informed consent for this study
排除标准
- •Vulnerable study population
- •Pregnant or nursing women
- •Women planning a pregnancy within the study period
- •Human immunodeficiency virus (HIV) positivity
- •Known history of adverse reaction to Bimzelx
- •Known history of hepatitis B, hepatitis C, or tuberculosis
- •Personal or family history of inflammatory bowel disease
研究组 & 干预措施
Bimzelx
Patients will be treated with Bimzelx for pityriasis rubra pilaris, 320 mg, by subcutaneous injection.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Number of patients with ≥ 75% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 24 weeks
时间窗: 24 weeks
The Psoriasis Area and Severity Index (PASI) is a measure of disease activity assessed using the degree of body surface area involvement, the severity of lesions, and assessment of lesional erythema, induration, and scaling. These calculations are combined into a single score that ranges from 0 (no skin disease) to 72 (near complete skin involvement).
次要结局
- Number of patients with ≥ 90% improvement of Psoriasis Area and Severity Index (PASI) score from baseline to 28 weeks(28 weeks)
- Change in Physician Global Assessment (PGA) score(Baseline, 28 weeks)
- Change in Dermatology Life Quality Index (DLQI) score(Baseline, 28 weeks)
研究者
Jason Sluzevich MD
Principal Investigator
Mayo Clinic