2024-517623-39-00招募中3 期
An Open-label, Multicenter Study to Evaluate the Long-term Safety and Efficacy of Ulviprubart (ABC008) in Subjects Who Have Completed a Trial of Ulviprubart for the Treatment of Inclusion Body Myositis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Abcuro Inc.
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs).
研究概览
简要总结
Assess the long-term safety and tolerability of ulviprubart (ABC008) in subjects with inclusion.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Able to read, understand, and provide signed informed consent prior to the performance of any study-related procedures
- •Has participated in and completed either Study ABC008-IBM-101 or Study ABC008-IBM-201; completion of the prior study will be defined as completion of the Part 2 (MAD) EOT Visit in Study ABC008-IBM-101 (subjects may have continued into Part 3 [MAD Extension]) or completion of the Week 80 Follow-up Visit in Study ABC008-IBM-
- •Demonstrated adequate compliance, in the opinion of the Investigator, with the study procedures during Study ABC008-IBM-101 or Study ABC008-IBM-201
- •Willing and able to comply with the requirements of the protocol, including traveling to the site for study-related assessments and SC injections of ulviprubart.
- •Women of childbearing potential (WOCBP) and male subjects with female partners who are WOCBP (based on sex assignation at birth) must agree to use highly effective (< 1% failure rate) contraception for the duration of the study through 180 days after EOT/ETV.
- •WOCBP (based on sex assignation at birth) must have a negative urine pregnancy test at the Baseline (Day 1) Visit.
- •Male subjects (based on sex assignation at birth) must refrain from sperm donation for the duration of the study through 180 days after EOT/ETV.
排除标准
- •Has an unresolved clinically significant AE or a clinically significant finding on a clinical laboratory test, electrocardiogram, or physical examination during Study ABC008-IBM-101 or Study ABC008-IBM-201 that, in the Investigator’s opinion, would limit the subject’s ability to participate in or comply with this study.
- •Participation in another investigational drug study (other than Study ABC008-IBM-101 or Study ABC008-IBM-201) within 30 days prior to the Baseline (Day 1) Visit or five times the half-life of the investigational drug, whichever is longer.
- •Is not willing or able to comply with the restrictions regarding the use of prohibited medications throughout the study
- •Women who are pregnant, lactating, or who plan to become pregnant or initiate lactation during the study
结局指标
主要结局
The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs).
The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs).
次要结局
- Safety:Incidence, type, and severity of treatment-emergent serious adverse events (TESAEs)
- Safety: Incidence of TEAEs leading to study medication or study discontinuation
- Safety: Clinically significant changes in standard laboratory parameters and vital signs
- Safety: Adverse events of special interest (AESIs),
- Efficacy: Mean change from Baseline (Day 1) in IBMFRS over the duration of the study.
- Efficacy: Mean change from Baseline (Day 1) in MMT 12 over the duration of the study
研究者
Garry Weems
Scientific
Abcuro Inc.
研究点 (3)
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