2025-521642-14-00招募中2 期
An Open-Label Extension, Multi-centered, Phase 2 Trial to Describe the Safety and Efficacy of TEV-56286 (Emrusolmin) in Participants with Multiple System Atrophy
Teva Branded Pharmaceutical Products R&D LLC9 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2026年2月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 9
- 主要终点
- The primary safety and tolerability endpoints are as follows: • number (%) of participants experiencing an adverse event
研究概览
简要总结
The primary objective of the trial is to describe the long-term safety and tolerability of TEV 56286 administered orally for the treatment of adult participants with MSA
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
- •Completion of the treatment period and the week 48 (V9) visit of the DB trial whilst remaining compliant with trial requirements.
- •Is able to swallow the IMP, as determined by a dysphagia evaluation during the OLE baseline visit; and is willing to swallow the IMP capsules whole, and as scheduled, throughout the duration of the OLE trial
- •In the investigator’s opinion, the participant and where applicable, participant’s caregiver(s), has (have) the ability to understand the nature of the OLE trial and its procedures, and is (are) able and willing to comply with the requirements of the OLE trial
- •Participant must provide consent, either by signature, spoken word, or gesture. If participant is physically unable to provide written informed consent, the completed ICF must be signed by one of the following in accordance with local regulation: (1) legally acceptable representative (LAR) or (2) acknowledgement of participant’s consent by an impartial witness. The process for consent should follow the local regulatory requirements. Caregiver consent will also be obtained in the circumstances where caregiver participation is applicable.
- •Females of childbearing potential (CBP) may be included only if they have a negative pregnancy test at the OLE baseline visit
- •Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the OLE trial and for 28 days after the last dose of IMP
- •Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods for the duration of the OLE trial and for 28 days after the last dose of IMP
排除标准
- •Has any clinically significant uncontrolled medical or psychiatric condition (treated or untreated), or any findings from vital signs, imaging, physical examination, electrocardiogram (ECG), or clinical laboratory, other than MSA related that could jeopardize or compromise the participant’s ability to participate in the OLE trial. The investigator should consult with the medical monitor or trial physician as needed.
- •Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the OLE trial.
- •Has moderate to severe renal impairment as assessed by estimated glomerular filtration rate <60 mL/min/1.73m
- •Minor deviations or borderline results (up to 10 mL/minute/1.73m2) may be acceptable for eligibility at the discretion of the Principal Investigator.
- •Current or history of chronic liver or biliary disease, >2.5x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or 1.5x ULN total bilirubin (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •Has any clinically significant disorder that may interfere with absorption, distribution, metabolism, or excretion of IMP (including relevant gastrointestinal surgery, malabsorption syndrome) that makes the participant unsuitable for the trial.
- •Is of a vulnerable population (eg, people kept in detention or jail).
- •Is regularly using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial
结局指标
主要结局
The primary safety and tolerability endpoints are as follows: • number (%) of participants experiencing an adverse event
The primary safety and tolerability endpoints are as follows: • number (%) of participants experiencing an adverse event
The primary safety and tolerability endpoints are as follows: • number (%) of participants who withdraw from the trial due to an adverse event
The primary safety and tolerability endpoints are as follows: • number (%) of participants who withdraw from the trial due to an adverse event
次要结局
未报告次要终点
研究者
Medical Information
Scientific
Teva Branded Pharmaceutical Products R&D LLC
研究点 (9)
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