A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis
- Registration Number
- NCT02780388
- Lead Sponsor
- Amgen
- Brief Summary
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).
- Detailed Description
Study with completed results acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- adult-onset rheumatoid arthritis
- swollen and tender joints
- venous thromboembolism or arterial thrombosis
- pregnant or breastfeeding
- positive hepatitis B, hepatitis C, and human immunodeficiency virus infection
- active or untreated latent tuberculosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VIB4920 1500 mg VIB4920 Participants will receive a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks. VIB4920 75 mg VIB4920 Participants will receive a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks. Placebo 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. VIB4920 500 mg VIB4920 Participants will receive a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks. VIB4920 1000 mg VIB4920 Participants will receive a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) 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) 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.
- Secondary Outcome Measures
Name Time Method 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 Systemic clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
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 Area under the plasma concentration time curve from time zero to extrapolated infinite time (AUC0-inf) of VIB4920 is reported.
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 Maximum observed plasma concentration (Cmax) of VIB4920 is reported.
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 Dose normalized AUCtau of VIB4920 is reported. Dose normalized AUCtau is calculated by dividing AUCtau by the dose of administered VIB4920 (in mg).
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 Time to maximum plasma concentration (Tmax) of VIB4920 is reported.
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 Area under the plasma concentration time curve of the dosing interval (AUCtau) of VIB4920 is reported.
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 Accumulation ratio of VIB4920 is reported. Accumulation ratio was determined using AUCtau, Dose 7/AUCtau, Dose 1.
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 The number of participants with positive antibodies to VIB4920 are reported.
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 Volume of distribution at steady state (Vss) of VIB4920 is reported.
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 Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.
Trial Locations
- Locations (1)
Research Site
🇵🇱Warszawa, Poland