Adult Onset Rheumatoid Arthritis
Conditions
Keywords
MEDI4920, VIB4920, CD40L, RA, rheumatoid arthritis
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.
Interventions
DRUGVIB4920
Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.
OTHERPlacebo
Participants will receive a single IV dose of placebo matched to VIB4920 Q2W from Day 1 up to 12 weeks.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* adult-onset rheumatoid arthritis * swollen and tender joints
Exclusion criteria
* venous thromboembolism or arterial thrombosis * pregnant or breastfeeding * positive hepatitis B, hepatitis C, and human immunodeficiency virus infection * active or untreated latent tuberculosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Poland, United States
Participant flow
Recruitment details
The study was conducted from 12 May 2016 to 09 Aug 2018 in Poland and the United States of America.
Pre-assignment details
A total of 117 participants were screened in the study, out of which 60 were screen failures. A total of 57 participants were randomized in this study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks. | 15 |
| VIB4920 75 mg Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks. | 8 |
| VIB4920 500 mg Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks. | 10 |
| VIB4920 1000 mg Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks. | 12 |
| VIB4920 1500 mg Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks. | 12 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | VIB4920 75 mg | VIB4920 500 mg | VIB4920 1000 mg | VIB4920 1500 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 8 | 57.9 years STANDARD_DEVIATION 7.4 | 53.7 years STANDARD_DEVIATION 9.8 | 52.1 years STANDARD_DEVIATION 11.5 | 50.9 years STANDARD_DEVIATION 8.6 | 54.6 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 6 Participants | 9 Participants | 11 Participants | 12 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 8 Participants | 9 Participants | 10 Participants | 12 Participants | 52 Participants |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 6 Participants | 10 Participants | 10 Participants | 46 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 8 | 0 / 10 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 13 / 15 | 3 / 8 | 7 / 10 | 6 / 12 | 10 / 12 |
| serious Total, serious adverse events | 0 / 15 | 0 / 8 | 0 / 10 | 0 / 12 | 1 / 12 |
Outcome results
Primary
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
Population: As-treated population included all treated participants, grouped according to actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs | 13 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAEs | 0 Participants |
| VIB4920 75 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs | 3 Participants |
| VIB4920 75 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAEs | 0 Participants |
| VIB4920 500 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs | 7 Participants |
| VIB4920 500 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAEs | 0 Participants |
| VIB4920 1000 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAEs | 0 Participants |
| VIB4920 1000 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs | 6 Participants |
| VIB4920 1500 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs | 10 Participants |
| VIB4920 1500 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAEs | 1 Participants |
Primary
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
Population: As-treated population included all treated participants, grouped according to actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Encephalitis | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Oral herpes | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Herpes simplex | 0 Participants |
| VIB4920 75 mg | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Herpes simplex | 0 Participants |
| VIB4920 75 mg | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Encephalitis | 0 Participants |
| VIB4920 75 mg | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Oral herpes | 0 Participants |
| VIB4920 500 mg | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Herpes simplex | 0 Participants |
| VIB4920 500 mg | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Encephalitis | 0 Participants |
| VIB4920 500 mg | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Oral herpes | 0 Participants |
| VIB4920 1000 mg | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Encephalitis | 0 Participants |
| VIB4920 1000 mg | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Oral herpes | 1 Participants |
| VIB4920 1000 mg | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Herpes simplex | 0 Participants |
| VIB4920 1500 mg | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Herpes simplex | 1 Participants |
| VIB4920 1500 mg | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Encephalitis | 1 Participants |
| VIB4920 1500 mg | Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) | Oral herpes | 0 Participants |
Secondary
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
Population: Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Accumulation Ratio (AR) of VIB4920 | 1.51 Ratio | Standard Deviation 0.265 |
| VIB4920 75 mg | Accumulation Ratio (AR) of VIB4920 | 1.51 Ratio | Standard Deviation 0.287 |
| VIB4920 500 mg | Accumulation Ratio (AR) of VIB4920 | 1.20 Ratio | Standard Deviation 0.251 |
| VIB4920 1000 mg | Accumulation Ratio (AR) of VIB4920 | 1.76 Ratio | Standard Deviation 0.305 |
Secondary
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
Population: Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920 | 163 µg*day/mL | Standard Deviation 42.7 |
| VIB4920 75 mg | Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920 | 824 µg*day/mL | Standard Deviation 228 |
| VIB4920 500 mg | Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920 | 2660 µg*day/mL | Standard Deviation 744 |
| VIB4920 1000 mg | Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920 | 3480 µg*day/mL | Standard Deviation 842 |
Secondary
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
Population: Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920 | Dose 1 | 122 µg*day/mL | Standard Deviation 25.5 |
| Placebo | Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920 | Dose 7 | 262 µg*day/mL | Standard Deviation 94.7 |
| VIB4920 75 mg | Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920 | Dose 7 | 1430 µg*day/mL | Standard Deviation 466 |
| VIB4920 75 mg | Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920 | Dose 1 | 669 µg*day/mL | Standard Deviation 164 |
| VIB4920 500 mg | Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920 | Dose 1 | 2150 µg*day/mL | Standard Deviation 496 |
| VIB4920 500 mg | Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920 | Dose 7 | 3760 µg*day/mL | Standard Deviation 1370 |
| VIB4920 1000 mg | Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920 | Dose 1 | 2360 µg*day/mL | Standard Deviation 466 |
| VIB4920 1000 mg | Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920 | Dose 7 | 5850 µg*day/mL | Standard Deviation 1530 |
Secondary
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
Population: Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analysed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Dose Normalized AUCtau of VIB4920 | Dose 1 | 1.62 µg*day/mL/mg | Standard Deviation 0.341 |
| Placebo | Dose Normalized AUCtau of VIB4920 | Dose 7 | 3.49 µg*day/mL/mg | Standard Deviation 1.26 |
| VIB4920 75 mg | Dose Normalized AUCtau of VIB4920 | Dose 7 | 2.87 µg*day/mL/mg | Standard Deviation 0.931 |
| VIB4920 75 mg | Dose Normalized AUCtau of VIB4920 | Dose 1 | 1.34 µg*day/mL/mg | Standard Deviation 0.328 |
| VIB4920 500 mg | Dose Normalized AUCtau of VIB4920 | Dose 1 | 2.15 µg*day/mL/mg | Standard Deviation 0.496 |
| VIB4920 500 mg | Dose Normalized AUCtau of VIB4920 | Dose 7 | 3.76 µg*day/mL/mg | Standard Deviation 1.37 |
| VIB4920 1000 mg | Dose Normalized AUCtau of VIB4920 | Dose 1 | 1.58 µg*day/mL/mg | Standard Deviation 0.311 |
| VIB4920 1000 mg | Dose Normalized AUCtau of VIB4920 | Dose 7 | 3.90 µg*day/mL/mg | Standard Deviation 1.02 |
Secondary
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
Population: Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Maximum Observed Plasma Concentration (Cmax) of VIB4920 | Dose 1 | 20.6 µg/mL | Standard Deviation 5.26 |
| Placebo | Maximum Observed Plasma Concentration (Cmax) of VIB4920 | Dose 7 | 24.4 µg/mL | Standard Deviation 3.72 |
| VIB4920 75 mg | Maximum Observed Plasma Concentration (Cmax) of VIB4920 | Dose 7 | 157 µg/mL | Standard Deviation 40.7 |
| VIB4920 75 mg | Maximum Observed Plasma Concentration (Cmax) of VIB4920 | Dose 1 | 158 µg/mL | Standard Deviation 95.4 |
| VIB4920 500 mg | Maximum Observed Plasma Concentration (Cmax) of VIB4920 | Dose 1 | 392 µg/mL | Standard Deviation 84.4 |
| VIB4920 500 mg | Maximum Observed Plasma Concentration (Cmax) of VIB4920 | Dose 7 | 423 µg/mL | Standard Deviation 114 |
| VIB4920 1000 mg | Maximum Observed Plasma Concentration (Cmax) of VIB4920 | Dose 1 | 360 µg/mL | Standard Deviation 83.8 |
| VIB4920 1000 mg | Maximum Observed Plasma Concentration (Cmax) of VIB4920 | Dose 7 | 627 µg/mL | Standard Deviation 159 |
Secondary
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
Population: Intent-to treat population included all randomized and treated participants, grouped according to assigned treatment. Participants with available ADA sample were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920 | 3 Participants |
| VIB4920 75 mg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920 | 3 Participants |
| VIB4920 500 mg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920 | 1 Participants |
| VIB4920 1000 mg | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920 | 0 Participants |
Secondary
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
Population: Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Systemic Clearance (CL) of VIB4920 | Dose 1 | 489 mL/day | Standard Deviation 135 |
| Placebo | Systemic Clearance (CL) of VIB4920 | Dose 7 | 449 mL/day | Standard Deviation 129 |
| VIB4920 75 mg | Systemic Clearance (CL) of VIB4920 | Dose 7 | 536 mL/day | Standard Deviation 152 |
| VIB4920 75 mg | Systemic Clearance (CL) of VIB4920 | Dose 1 | 654 mL/day | Standard Deviation 203 |
| VIB4920 500 mg | Systemic Clearance (CL) of VIB4920 | Dose 1 | 405 mL/day | Standard Deviation 120 |
| VIB4920 500 mg | Systemic Clearance (CL) of VIB4920 | Dose 7 | 421 mL/day | Standard Deviation 107 |
| VIB4920 1000 mg | Systemic Clearance (CL) of VIB4920 | Dose 1 | 457 mL/day | Standard Deviation 120 |
| VIB4920 1000 mg | Systemic Clearance (CL) of VIB4920 | Dose 7 | 381 mL/day | Standard Deviation 94.8 |
Secondary
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
Population: Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Terminal Elimination Half-life (t½) of VIB4920 | Dose 1 | 6.25 Days | Standard Deviation 1.26 |
| Placebo | Terminal Elimination Half-life (t½) of VIB4920 | Dose 7 | 7.82 Days | Standard Deviation 1.5 |
| VIB4920 75 mg | Terminal Elimination Half-life (t½) of VIB4920 | Dose 7 | 9.58 Days | Standard Deviation 1.57 |
| VIB4920 75 mg | Terminal Elimination Half-life (t½) of VIB4920 | Dose 1 | 5.61 Days | Standard Deviation 0.891 |
| VIB4920 500 mg | Terminal Elimination Half-life (t½) of VIB4920 | Dose 1 | 6.12 Days | Standard Deviation 0.725 |
| VIB4920 500 mg | Terminal Elimination Half-life (t½) of VIB4920 | Dose 7 | 9.72 Days | Standard Deviation 1.32 |
| VIB4920 1000 mg | Terminal Elimination Half-life (t½) of VIB4920 | Dose 1 | 8.70 Days | Standard Deviation 2.61 |
| VIB4920 1000 mg | Terminal Elimination Half-life (t½) of VIB4920 | Dose 7 | 9.58 Days | Standard Deviation 1.37 |
Secondary
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
Population: Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to Maximum Plasma Concentration (Tmax) of VIB4920 | Dose 1 | 0.02 Days |
| Placebo | Time to Maximum Plasma Concentration (Tmax) of VIB4920 | Dose 7 | 0.02 Days |
| VIB4920 75 mg | Time to Maximum Plasma Concentration (Tmax) of VIB4920 | Dose 1 | 0.04 Days |
| VIB4920 75 mg | Time to Maximum Plasma Concentration (Tmax) of VIB4920 | Dose 7 | 0.04 Days |
| VIB4920 500 mg | Time to Maximum Plasma Concentration (Tmax) of VIB4920 | Dose 1 | 0.06 Days |
| VIB4920 500 mg | Time to Maximum Plasma Concentration (Tmax) of VIB4920 | Dose 7 | 0.06 Days |
| VIB4920 1000 mg | Time to Maximum Plasma Concentration (Tmax) of VIB4920 | Dose 7 | 0.06 Days |
| VIB4920 1000 mg | Time to Maximum Plasma Concentration (Tmax) of VIB4920 | Dose 1 | 0.06 Days |
Secondary
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
Population: Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Volume of Distribution at Steady State (Vss) of VIB4920 | Dose 1 | 4230 mL | Standard Deviation 595 |
| Placebo | Volume of Distribution at Steady State (Vss) of VIB4920 | Dose 7 | 5060 mL | Standard Deviation 980 |
| VIB4920 75 mg | Volume of Distribution at Steady State (Vss) of VIB4920 | Dose 7 | 5600 mL | Standard Deviation 1010 |
| VIB4920 75 mg | Volume of Distribution at Steady State (Vss) of VIB4920 | Dose 1 | 5040 mL | Standard Deviation 1220 |
| VIB4920 500 mg | Volume of Distribution at Steady State (Vss) of VIB4920 | Dose 1 | 3510 mL | Standard Deviation 844 |
| VIB4920 500 mg | Volume of Distribution at Steady State (Vss) of VIB4920 | Dose 7 | 4620 mL | Standard Deviation 1060 |
| VIB4920 1000 mg | Volume of Distribution at Steady State (Vss) of VIB4920 | Dose 1 | 5380 mL | Standard Deviation 1210 |
| VIB4920 1000 mg | Volume of Distribution at Steady State (Vss) of VIB4920 | Dose 7 | 4100 mL | Standard Deviation 905 |