Trial Outcomes & Findings for A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis (NCT NCT02780388)
NCT ID: NCT02780388
Last Updated: 2024-12-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
Day 1 through Day 169
Results posted on
2024-12-27
Participant Flow
The study was conducted from 12 May 2016 to 09 Aug 2018 in Poland and the United States of America.
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.
Participant milestones
| Measure |
Placebo
Participants received 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 75 mg
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
8
|
10
|
12
|
12
|
|
Overall Study
COMPLETED
|
14
|
6
|
10
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received 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 75 mg
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=8 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=10 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
50.9 years
STANDARD_DEVIATION 8.6 • n=21 Participants
|
54.6 years
STANDARD_DEVIATION 9.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 169Population: As-treated population included all treated participants, grouped according to actual treatment received.
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.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=8 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=10 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
13 Participants
|
3 Participants
|
7 Participants
|
6 Participants
|
10 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 169Population: As-treated population included all treated participants, grouped according to actual treatment received.
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.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=8 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=10 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)
Encephalitis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)
Herpes simplex
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)
Oral herpes
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 169Population: 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.
Maximum observed plasma concentration (Cmax) of VIB4920 is reported.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=10 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=12 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of VIB4920
Dose 1
|
20.6 µg/mL
Standard Deviation 5.26
|
158 µg/mL
Standard Deviation 95.4
|
392 µg/mL
Standard Deviation 84.4
|
360 µg/mL
Standard Deviation 83.8
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of VIB4920
Dose 7
|
24.4 µg/mL
Standard Deviation 3.72
|
157 µg/mL
Standard Deviation 40.7
|
423 µg/mL
Standard Deviation 114
|
627 µg/mL
Standard Deviation 159
|
—
|
SECONDARY outcome
Timeframe: 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 169Population: 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.
Time to maximum plasma concentration (Tmax) of VIB4920 is reported.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=10 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=12 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of VIB4920
Dose 1
|
0.02 Days
Interval 0.02 to 1.0
|
0.04 Days
Interval 0.04 to 0.04
|
0.06 Days
Interval 0.06 to 1.0
|
0.06 Days
Interval 0.06 to 0.06
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of VIB4920
Dose 7
|
0.02 Days
Interval 0.02 to 0.02
|
0.04 Days
Interval 0.04 to 0.04
|
0.06 Days
Interval 0.06 to 0.06
|
0.06 Days
Interval 0.06 to 0.06
|
—
|
SECONDARY outcome
Timeframe: 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 169Population: 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.
Area under the plasma concentration time curve of the dosing interval (AUCtau) of VIB4920 is reported.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=10 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=12 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920
Dose 1
|
122 µg*day/mL
Standard Deviation 25.5
|
669 µg*day/mL
Standard Deviation 164
|
2150 µg*day/mL
Standard Deviation 496
|
2360 µg*day/mL
Standard Deviation 466
|
—
|
|
Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920
Dose 7
|
262 µg*day/mL
Standard Deviation 94.7
|
1430 µg*day/mL
Standard Deviation 466
|
3760 µg*day/mL
Standard Deviation 1370
|
5850 µg*day/mL
Standard Deviation 1530
|
—
|
SECONDARY outcome
Timeframe: 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 169Population: 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.
Dose normalized AUCtau of VIB4920 is reported. Dose normalized AUCtau is calculated by dividing AUCtau by the dose of administered VIB4920 (in mg).
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=10 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=12 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Dose Normalized AUCtau of VIB4920
Dose 1
|
1.62 µg*day/mL/mg
Standard Deviation 0.341
|
1.34 µg*day/mL/mg
Standard Deviation 0.328
|
2.15 µg*day/mL/mg
Standard Deviation 0.496
|
1.58 µg*day/mL/mg
Standard Deviation 0.311
|
—
|
|
Dose Normalized AUCtau of VIB4920
Dose 7
|
3.49 µg*day/mL/mg
Standard Deviation 1.26
|
2.87 µg*day/mL/mg
Standard Deviation 0.931
|
3.76 µg*day/mL/mg
Standard Deviation 1.37
|
3.90 µg*day/mL/mg
Standard Deviation 1.02
|
—
|
SECONDARY outcome
Timeframe: 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 169Population: 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.
Area under the plasma concentration time curve from time zero to extrapolated infinite time (AUC0-inf) of VIB4920 is reported.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=10 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=10 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
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
|
824 µg*day/mL
Standard Deviation 228
|
2660 µg*day/mL
Standard Deviation 744
|
3480 µg*day/mL
Standard Deviation 842
|
—
|
SECONDARY outcome
Timeframe: 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 169Population: 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.
Systemic clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=10 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=12 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Systemic Clearance (CL) of VIB4920
Dose 1
|
489 mL/day
Standard Deviation 135
|
654 mL/day
Standard Deviation 203
|
405 mL/day
Standard Deviation 120
|
457 mL/day
Standard Deviation 120
|
—
|
|
Systemic Clearance (CL) of VIB4920
Dose 7
|
449 mL/day
Standard Deviation 129
|
536 mL/day
Standard Deviation 152
|
421 mL/day
Standard Deviation 107
|
381 mL/day
Standard Deviation 94.8
|
—
|
SECONDARY outcome
Timeframe: 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 169Population: 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.
Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=10 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=12 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t½) of VIB4920
Dose 1
|
6.25 Days
Standard Deviation 1.26
|
5.61 Days
Standard Deviation 0.891
|
6.12 Days
Standard Deviation 0.725
|
8.70 Days
Standard Deviation 2.61
|
—
|
|
Terminal Elimination Half-life (t½) of VIB4920
Dose 7
|
7.82 Days
Standard Deviation 1.50
|
9.58 Days
Standard Deviation 1.57
|
9.72 Days
Standard Deviation 1.32
|
9.58 Days
Standard Deviation 1.37
|
—
|
SECONDARY outcome
Timeframe: 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 169Population: 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.
Volume of distribution at steady state (Vss) of VIB4920 is reported.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=10 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=12 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of VIB4920
Dose 1
|
4230 mL
Standard Deviation 595
|
5040 mL
Standard Deviation 1220
|
3510 mL
Standard Deviation 844
|
5380 mL
Standard Deviation 1210
|
—
|
|
Volume of Distribution at Steady State (Vss) of VIB4920
Dose 7
|
5060 mL
Standard Deviation 980
|
5600 mL
Standard Deviation 1010
|
4620 mL
Standard Deviation 1060
|
4100 mL
Standard Deviation 905
|
—
|
SECONDARY outcome
Timeframe: 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 169Population: 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.
Accumulation ratio of VIB4920 is reported. Accumulation ratio was determined using AUCtau, Dose 7/AUCtau, Dose 1.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=10 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=12 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=11 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Accumulation Ratio (AR) of VIB4920
|
1.51 Ratio
Standard Deviation 0.265
|
1.51 Ratio
Standard Deviation 0.287
|
1.20 Ratio
Standard Deviation 0.251
|
1.76 Ratio
Standard Deviation 0.305
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Days 1, 29, 57, and 85; and on Days 141, and 169Population: Intent-to treat population included all randomized and treated participants, grouped according to assigned treatment. Participants with available ADA sample were analyzed.
The number of participants with positive antibodies to VIB4920 are reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=10 Participants
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=12 Participants
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 Participants
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
VIB4920 75 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
VIB4920 500 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
VIB4920 1000 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
VIB4920 1500 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=15 participants at risk
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=8 participants at risk
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=10 participants at risk
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 participants at risk
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
n=12 participants at risk
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Encephalitis
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
Other adverse events
| Measure |
Placebo
n=15 participants at risk
Participants received a single intravascular (IV) dose of placebo matched to VIB4920 once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
|
VIB4920 75 mg
n=8 participants at risk
Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 500 mg
n=10 participants at risk
Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1000 mg
n=12 participants at risk
Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
|
VIB4920 1500 mg
n=12 participants at risk
Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
26.7%
4/15 • Number of events 4 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
16.7%
2/12 • Number of events 2 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
25.0%
2/8 • Number of events 3 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Infections and infestations
Acute sinusitis
|
13.3%
2/15 • Number of events 2 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
16.7%
2/12 • Number of events 2 • Day 1 through Day 169
|
|
General disorders
Fatigue
|
13.3%
2/15 • Number of events 2 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 2 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
25.0%
3/12 • Number of events 3 • Day 1 through Day 169
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
20.0%
2/10 • Number of events 2 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
25.0%
3/12 • Number of events 3 • Day 1 through Day 169
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 2 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
20.0%
2/10 • Number of events 6 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Vascular disorders
Hot flush
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
16.7%
2/12 • Number of events 3 • Day 1 through Day 169
|
|
Infections and infestations
Oral herpes
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Day 1 through Day 169
|
12.5%
1/8 • Number of events 2 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Psychiatric disorders
Agitation
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Investigations
Blood pressure increased
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Investigations
Body temperature increased
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Nervous system disorders
Cerebral small vessel ischemic disease
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
General disorders
Chest pain
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 2 • Day 1 through Day 169
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Day 1 through Day 169
|
12.5%
1/8 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
General disorders
Cyst
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Eye disorders
Dry eye
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Eye disorders
Eye irritation
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/15 • Day 1 through Day 169
|
12.5%
1/8 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • Number of events 2 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Injury, poisoning and procedural complications
Laceration
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Infections and infestations
Laryngitis
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Renal and urinary disorders
Leukocyturia
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Infections and infestations
Localised infection
|
0.00%
0/15 • Day 1 through Day 169
|
12.5%
1/8 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Infections and infestations
Lymphangitis
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Reproductive system and breast disorders
Menstruation irregular
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Day 1 through Day 169
|
12.5%
1/8 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 2 • Day 1 through Day 169
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
General disorders
Oedema
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Nervous system disorders
Paraesthesia
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
General disorders
Peripheral swelling
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/15 • Day 1 through Day 169
|
12.5%
1/8 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Gastrointestinal disorders
Salivary duct obstruction
|
0.00%
0/15 • Day 1 through Day 169
|
12.5%
1/8 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Investigations
Transaminases increased
|
6.7%
1/15 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Nervous system disorders
Tremor
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
10.0%
1/10 • Number of events 1 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
|
Investigations
Vitamin B12 decreased
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/15 • Day 1 through Day 169
|
0.00%
0/8 • Day 1 through Day 169
|
0.00%
0/10 • Day 1 through Day 169
|
0.00%
0/12 • Day 1 through Day 169
|
8.3%
1/12 • Number of events 1 • Day 1 through Day 169
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Viela Bio has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it is understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multicentre publication.
- Publication restrictions are in place
Restriction type: OTHER