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).
Study with completed results acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
57
Research Site
Anniston, Alabama, United States
Research Site
DeBary, Florida, United States
Research Site
Jacksonville, Florida, United States
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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.
Time frame: Day 1 through Day 169
Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)
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.
Time frame: Day 1 through Day 169
Maximum Observed Plasma Concentration (Cmax) of VIB4920
Maximum observed plasma concentration (Cmax) of VIB4920 is reported.
Time frame: 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
Time to maximum plasma concentration (Tmax) of VIB4920 is reported.
Time frame: 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
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Research Site
Miami Lakes, Florida, United States
Research Site
South Miami, Florida, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Mesquite, Texas, United States
Research Site
Bialystok, Poland
Research Site
Bydgoszcz, Poland
...and 2 more locations
Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920
Area under the plasma concentration time curve of the dosing interval (AUCtau) of VIB4920 is reported.
Time frame: 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 normalized AUCtau of VIB4920 is reported. Dose normalized AUCtau is calculated by dividing AUCtau by the dose of administered VIB4920 (in mg).
Time frame: 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
Area under the plasma concentration time curve from time zero to extrapolated infinite time (AUC0-inf) of VIB4920 is reported.
Time frame: 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
Systemic Clearance (CL) of VIB4920
Systemic clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: 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
Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.
Time frame: 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
Volume of distribution at steady state (Vss) of VIB4920 is reported.
Time frame: 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
Accumulation ratio of VIB4920 is reported. Accumulation ratio was determined using AUCtau, Dose 7/AUCtau, Dose 1.
Time frame: 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
The number of participants with positive antibodies to VIB4920 are reported.
Time frame: Pre-dose on Days 1, 29, 57, and 85; and on Days 141, and 169