CTIS2023-509832-24-00进行中（未招募）1 期
A Multicenter, Open-Label, Randomized Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis - PS0020
CB Biopharma0 个研究点目标入组 43 人开始时间: 2024年4月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Participant must be =12 to <18 years of age at the time of signing the informed consent/assent according to local regulation -Participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit and: a) Body surface area (BSA) affected by PSO =10% b) Investigator's Global Assessment (IGA) score =3 (on a scale from 0 to 4) c) Psoriasis Area and Severity Index (PASI) score =12 OR d) PASI score =10 plus at least 1 of the following: i. Clinically relevant facial involvement ii. Clinically relevant genital involvement iii. Clinically relevant hand and foot involvement -Participant must be candidate for systemic PSO therapy and/or photo/chemotherapy -Body weight =30 kg and body mass index for age percentile of =5 at Baseline -Male or female A female participant will be eligible to participate if she is not pregnant, not breastfeeding, and a woman of childbearing potential (WOCBP) agrees to follow the contraceptive guidance -Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate)
排除标准
- •-Participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO -Participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD - History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated -Participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections) -Participant has laboratory abnormalities at Screening -Participant has experienced primary failure to one or more interleukin-17 (IL-17) biologic response modifier OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier -Presence of active suicidal ideation, or positive suicide behavior -Participant has been diagnosed with severe depression in the past 6 months
研究者
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