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
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Abcuro, Inc.
- 入组人数
- 270
- 试验地点
- 21
- 主要终点
- Primary Endpoint
研究概览
简要总结
ABC008-IBM-202 is an open-label, multicenter study to evaluate the safety and efficacy of long-term administration of ulviprubart (ABC008) in subjects with IBM who have completed either Study ABC008-IBM-101 or Study ABC008-IBM-201. Subjects may be enrolled in this study if they meet study eligibility criteria and:
- Have completed the Part 2 (Multiple Ascending Dose [MAD]) End of-Treatment (EOT) Visit in Study ABC008-IBM-101; subjects who continued further on into Part 3 of the study (MAD Extension) prior to enrolling in this study are also eligible; OR
- Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201.
详细描述
ABC008-IBM-202 is an open-label, multicenter study to evaluate the safety and efficacy of long-term administration of ulviprubart (ABC008) in subjects with IBM who have completed either Study ABC008-IBM-101 or Study ABC008-IBM-201. Subjects may be enrolled in this study if they meet study eligibility criteria and:
- Have completed the Part 2 (Multiple Ascending Dose [MAD]) End of-Treatment (EOT) Visit in Study ABC008-IBM-101; subjects who continued further on into Part 3 of the study (MAD Extension) prior to enrolling in this study are also eligible; OR
- Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201. Subjects will enter this study following their initial study such that dosing continues every eight weeks (Q8W) between the last dose in the initial study and the first dose in this long-term extension (LTE) Study IBM-202. Study subjects will continue to receive any ongoing concomitant medications from the initial study.
Subjects will be required to sign an informed consent form before undertaking any study-specific procedures or assessments. Screening is intended to be done at the final visit of the initial study, which will coincide with the Baseline (Day 1) Visit for this study; if this is not possible, the Baseline (Day 1) Visit for this study, including screening, may be conducted at a separate visit (provided it occurs within the visit window defined in Appendix 1 of the protocol). Subsequent study visits will occur every eight weeks until EOT at Week 156, or withdrawal from the study.
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
- •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-
- •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, ECG, 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.
研究组 & 干预措施
Ulviprubart (ABC008) 2.0 mg/kg SC
All eligible subjects, regardless of treatment assignment or dose level in their initial study, will be administered ulviprubart at a dose of 2.0 mg/kg via subcutaneous (SC) injection Q8W.
干预措施: Ulviprubart (ABC008) (Drug)
结局指标
主要结局
Primary Endpoint
时间窗: From Baseline (Day 1) through study completion, an average of 156 weeks.]
The primary endpoint for the study will be the incidence, type, and severity of treatment-emergent adverse events (TEAEs). Safety as assessed by the incidence, type and severity of Treatment Emergent Adverse Events (TEAEs)
次要结局
- Change from baseline in standard laboratory parameters (Coagulation)(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Change from baseline in standard vital signs (temperature)(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Treatment Emergent Serious Adverse Events (TEASAEs)(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Treatment Emergent Adverse Events (TEAEs) onset within 24 hours of Study Medication Administration.(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Change from baseline standard laboratory parameters (Hematology)(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Change from baseline in standard laboratory parameters (Chemistry)(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Inclusion Body Myositis Functional Rating Scale (IBMFRS)(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Adverse Events of Special Interest (AESI)(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Presence and titer of antidrug antibodies (ADA)(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Serum concentration of ulviprubart(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Change from baseline in standard vital signs blood pressure(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Change from baseline in standard vital signs (respiratory rate)(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Change from baseline in standard vital signs (pulse rate)(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Counts of absolute and KLRG1+ lymphocytes by flow cytometry.(From Baseline (Day 1) through study completion, an average of 156 weeks.])
- Manual Muscle Test 12 (MMT 12)(From Baseline (Day 1) through study completion, an average of 156 weeks.])