NCT04658199进行中（未招募）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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 12
- 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
The purpose of the study is to assess the long-term safety and tolerability of UCB0107 in study participants with progressive supranuclear palsy (PSP).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 (Hoeglinger et al, 2017)
- •Participant completed the Treatment Period (regardless of the total number of infusions) in PSP003 (NCT04185415)
- •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 (NCT04185415)
- •Participant made a suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt) during PSP003 (NCT04185415), 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 (CSSRS) 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
研究组 & 干预措施
UCB0107 (bepranemab)
Experimental
Subjects in this study arm will receive Intravenous UCB0107.
干预措施: UCB0107 (bepranemab) (Drug)
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
时间窗: From Baseline of the open-label extension to end of study visit (up to 7 years)
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
次要结局
未报告次要终点
研究者
研究点 (12)
Loading locations...
相似试验
已完成
3 期
A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With HypertensionHypertensionNCT00457626Novartis Pharmaceuticals66
已完成
3 期
Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.Multiple SclerosisNCT01235221Biogen38
进行中（未招募）
2 期
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionNCT05649748Insmed Incorporated91
招募中
3 期
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without InhibitorsHemophilia AHemophilia BNCT05145127Pfizer245
已完成
2 期
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)Pulmonary HypertensionInterstitial Lung DiseaseNCT05649722Insmed Incorporated31