Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis Who Have an Inadequate Skin Response to Anti-IL23 Therapy
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Proportion of patients achieving MDA
研究概览
简要总结
This is an open-label study to evaluate the effects of bimekizumab in patients with psoriasis vulgaris and who also have active psoriatic arthritis (PsA).
详细描述
This study is being conducted to evaluate the effects of bimekizumab administered subcutaneously (SC) to patients with psoriasis vulgaris and who also have active PsA who have an inadequate skin response to anti-interleukin (IL)23 therapy. Approximately 20 adult subjects with psoriasis vulgaris and active PsA who have an inadequate skin response to anti-IL23 will receive bimekizumab 320 mg solution administered SC every 4 weeks for 16 weeks.
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
- •Male or female patient 18 years of age or older at the time of consent.
- •Patient with a history of psoriasis vulgaris and PsA (as determined by the investigator) for ≥ 6 months prior to the screening visit.
- •Patient with moderate-to-severe psoriasis vulgaris before initiating treatment with an anti-IL23 agent.
- •Patient with an inadequate skin response to at least 12 weeks treatment with an anti-IL23 agent for the treatment of psoriasis vulgaris as defined by a PGA ≥ 2 and plaque psoriasis covering ≥ 1% of total BSA (excluding palms and soles) at the screening and Day 1 visits.
- •Patient with active PsA as defined by ≥ 1 joint that is tender (TJC68) and/or swollen (SJC66) at Day 1.
排除标准
- •Female who is breastfeeding, pregnant, or who is planning to become pregnant during the study or within 4 months after the last study product administration.
- •Patient with evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis.
- •Patient with any known clinically significant medical condition or presence of a skin or rheumatologic disease that would, in the opinion of the investigator, put the patient at undue risk or interfere with the interpretation of study results.
- •Patient who plans to receive a live or live-attenuated vaccine during the study and up to 4 weeks or 5 half-lives (of the study product), whichever is longer, after the last study product administration.
- •Patient with an active infection (except common cold) that would place them at increased risk, a recent serious infection, or a history of opportunistic, recurrent, or chronic infections.
- •Patient with a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis).
- •Patient with known or suspected hypersensitivity to bimekizumab or any component of the investigational product, including any nonmedicinal ingredient, or component of the container.
- •Patient who has received any marketed or investigational biological agent, except anti-IL23 agents, within 12 weeks or 5 half-lives (whichever is longer) prior to Day
- •Patient who has received treatment with bimekizumab prior to Day 1.
研究组 & 干预措施
Bimekizumab 320 mg SC injections
Bimekizumab 320 mg solution administered via SC injections every 4 weeks for 16 weeks.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Proportion of patients achieving MDA
时间窗: Week 24
A patient will be considered to have achieved MDA when meeting 5/7 of the following criteria: tender joints count ≤ 1; swollen joints count ≤ 1; Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3%; patient pain visual analog scale (VAS) ≤ 15 mm; patient's global assessment of arthritis visual analog scale (PtGA VAS) ≤ 20 mm; Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤ 0.5; tender entheseal points ≤ 1.
Physician Global Assessment (PGA) x Body Surface Area (BSA)
时间窗: Week 24
The product of physician's global assessment and body surface area (PGA×BSA) is a measure of psoriasis severity (0-400), with higher scores indicating more severe disease.
次要结局
- Physician Global Assessment (PGA)(Weeks 12 and 24)
- Body Surface Area (BSA)(Weeks 12 and 24)
- Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC)(Week 24)
- Psoriasis Area and Severity Index (PASI)(Weeks 12 and 24)
- American College of Rheumatology (ACR)(Week 24)
- Swollen joints count (SJC)(Week 24)
- Physician's Global Assessment of Arthritis Visual Analogue Scale (MDGA VAS)(Week 24)
- Leeds Enthesitis Index (LEI)(Week 24)
- Health Assessment Questionnaire-Disability Index (HAQ-DI)(Weeks 12 and 24)
- Tender joints count (TJC)(Week 24)
- Patient's Assessment of Arthritis Pain Visual Analogue Scale (patient pain VAS)(Week 24)
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(Weeks 12 and 24)
- Patient's Global Assessment of Arthritis Visual Analogue Scale (PtGA VAS)(Week 24)
- Dactylitis Count(Week 24)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Weeks 12 and 24)