2024-510951-36-00招募中1 期
An Open-Label Extension Study to Evaluate the Safety and Tolerability of Long-Term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 6
- 主要终点
- Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study
研究概览
简要总结
Assessment of the long-term safety and tolerability of UCB0107 in study participants with progressive supranuclear palsy (PSP).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participant meets the criteria for possible or probable progressive supranuclear palsy (PSP) Richardson's Syndrome according to the Movement Disorder Society-PSP criteria (Höglinger et al, 2017) - Participant completed the Treatment Period (regardless of the total number of infusions) in PSP003 - Participant can be male or female a) A male participant must agree to use contraception as detailed in the protocol during the Treatment Period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period b) A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: I. Not a woman of childbearing potential (WOCBP) OR II. A WOCBP who agrees to follow the contraceptive guidance in the protocol during the Treatment Period and for at least 6 months after the last dose of study treatment. - Participant (or legal representative, as applicable and acceptable by local regulations) is giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed consent must be obtained before initiating any study procedures
排除标准
- •Participant has met a mandatory withdrawal and/or stopping criterion in PSP003 - Participant made a suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt) during PSP003, or has current suicidal ideation with at least some intent to act as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia Suicide Severity Rating Scale (C-SSRS) at the Day 1 Visit. However, participants will not be excluded if, based upon a mental healthcare professional assessment, and the investigator's judgment of benefit/risk, the participant is deemed suitable for receiving study medication
结局指标
主要结局
Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study
Incidence of treatment emergent adverse events from Baseline of the open-label extension to the end of the study
次要结局
未报告次要终点
研究者
UCB Cares
Scientific
UCB Biopharma
研究点 (6)
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