A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
A Phase 1, First-in-Human, Single Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of ABBV-519 in Subjects With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity.
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA.
This is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：ABBVIE CALL CENTER
- 电话号码：844-663-3742
- 邮箱：abbvieclinicaltrials@abbvie.com
学习地点
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Tokyo
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Bunkyo-ku、Tokyo、日本、113-8519
- 招聘中
- Institute of Science Tokyo Hospital /ID# 279648
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Alabama
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Anniston、Alabama、美国、36207
- 招聘中
- Pinnacle Research Group /ID# 278677
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California
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Tustin、California、美国、92780
- 招聘中
- Solace Research /ID# 279155
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Florida
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Clearwater、Florida、美国、33765
- 招聘中
- Clinical Research Of West Florida - Phase I Unit /ID# 279292
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Greenacres City、Florida、美国、33467
- 招聘中
- Finlay Medical Research - Greenacres /ID# 278380
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Kissimmee、Florida、美国、34741
- 招聘中
- Clinical Research of Osceola /ID# 278374
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Plantation、Florida、美国、33317
- 招聘中
- Discovery Health Research Center /ID# 279691
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Tampa、Florida、美国、33606
- 招聘中
- Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130
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Illinois
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Orland Park、Illinois、美国、60462
- 招聘中
- Advanced Quality Medical Research /ID# 279147
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Texas
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Red Oak、Texas、美国、75154
- 招聘中
- Epic Medical Research /ID# 279180
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
Key Inclusion Criteria:
- Individuals between 18 and 75 years of age inclusive at the time of Screening.
- Minimum baseline B-cell count of 50 cells/mcL.
Inclusion Criteria for SLE Participants:
- Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria.
- Positive ANA ≥ 1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double-stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome antigen A (SSA).
- Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score of ≥ 4 (excluding anti-dsDNA and C3/C4). Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility.
- Participants must have an inadequate response to ≥ 1 immunosuppressant therapies, used for at least 3 months.
Inclusion Criteria for RA Participants:
- Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA.
- Presence of rheumatoid factor (RF) or anti-citrullinated peptide antibodies (ACPA) above the ULN.
- Presence of at least 6 swollen and 6 tender joints
- High-sensitivity C-reactive protein (hs-CRP) ≥ 3 mg/L.
- Failed at least 1 conventional synthetic disease-modifying antirheumatic drug (DMARD) and ≥ 1 biological or targeted DMARDs of different classes.
Exclusion Criteria:
Key Exclusion Criteria:
- Participants with a history of infection.
- Participants with uncontrolled hypertension
Exclusion for SLE Participants:
Active neuropsychiatric SLE, or signs or symptoms of neuropsychiatric SLE within the 6 months prior to Screening (lupus headache permissible).
- Unstable or progressive glomerulonephritis (active class III or IV).
- SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease.
Exclusion for RA Participants:
-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group 1: Dose A
Participants will receive a single intravenous (IV) dose of ABBV-519
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Intravenous (IV) Infusion
Subcutaneous (SC) Injection
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实验性的：Group 2: Dose B
Participants will receive a single intravenous (IV) dose of ABBV-519
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Intravenous (IV) Infusion
Subcutaneous (SC) Injection
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实验性的：Group 3: Dose C
Participants will receive a single intravenous (IV) dose of ABBV-519
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Intravenous (IV) Infusion
Subcutaneous (SC) Injection
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实验性的：Group 4: Dose D
Participants will receive a single subcutaneous (SC) dose of ABBV-519
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Intravenous (IV) Infusion
Subcutaneous (SC) Injection
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实验性的：Group 5: Dose E
Participants will receive a single subcutaneous (SC) dose of ABBV-519
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Intravenous (IV) Infusion
Subcutaneous (SC) Injection
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in B Cells in Blood
大体时间：Up to 365 Days
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Change from baseline in B cells in blood.
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Up to 365 Days
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Maximum Plasma Concentration (Cmax) of ABBV-519.
大体时间：Up to 85 Days
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Cmax of ABBV-519
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Up to 85 Days
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Time to Cmax (Tmax) of ABBV-519
大体时间：Up to 85 Days
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Tmax of ABBV-519
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Up to 85 Days
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Terminal Phase Elimination Half-Life (t1/2) of ABBV-519
大体时间：Up to 85 Days
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t1/2 of ABBV-519
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Up to 85 Days
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Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519
大体时间：Up to 85 Days
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AUCt of ABBV-519
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Up to 85 Days
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Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519
大体时间：Up to 169 Days
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Percentage of participants with detection of ADAs for ABBV-519
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Up to 169 Days
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Number of Participants with Adverse Events (AEs)
大体时间：Up to 425 Days
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An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
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Up to 425 Days
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合作者和调查者
赞助
调查人员
- 研究主任：ABBVIE INC.、AbbVie
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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