A Phase 1b Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Clinical Response of MEDI4920 in Subjects With Adult-onset Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)
研究概览
简要总结
The purpose of this study is to determine whether VIB4920 (formerly MEDI4920) is safe and well tolerated in participants with adult-onset rheumatoid arthritis (RA).
详细描述
Study with completed results acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult-onset rheumatoid arthritis
- •swollen and tender joints
排除标准
- •venous thromboembolism or arterial thrombosis
- •pregnant or breastfeeding
- •positive hepatitis B, hepatitis C, and human immunodeficiency virus infection
- •active or untreated latent tuberculosis
研究组 & 干预措施
Placebo
Participants will receive a single intravascular (IV) dose of placebo matched to VIB4920 (formerly MEDI4920) once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
干预措施: Placebo (Other)
VIB4920 75 mg
Participants will receive a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
干预措施: VIB4920 (Drug)
VIB4920 500 mg
Participants will receive a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
干预措施: VIB4920 (Drug)
VIB4920 1000 mg
Participants will receive a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
干预措施: VIB4920 (Drug)
VIB4920 1500 mg
Participants will receive a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
干预措施: VIB4920 (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)
时间窗: Day 1 through Day 169
An AESI (serious or non-serious) is one of scientific and medical interest specific to understanding of study drug and may have required close monitoring, collection of additional information by investigator and rapid communication by investigator to the sponsor.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
时间窗: Day 1 through Day 169
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
次要结局
- Systemic Clearance (CL) of VIB4920(Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169)
- Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920(Post-dose (end of infusion) on Day 1, pre-dose on Day 15; pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169)
- Maximum Observed Plasma Concentration (Cmax) of VIB4920(Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169)
- Dose Normalized AUCtau of VIB4920(Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169)
- Time to Maximum Plasma Concentration (Tmax) of VIB4920(Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169)
- Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920(Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169)
- Accumulation Ratio (AR) of VIB4920(Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169)
- Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920(Pre-dose on Days 1, 29, 57, and 85; and on Days 141, and 169)
- Volume of Distribution at Steady State (Vss) of VIB4920(Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169)
- Terminal Elimination Half-life (t½) of VIB4920(Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169)