A Phase 1b Study of MEDI4920 in Participants With Adult-o... | NCT02780388

NCT02780388

ID	Type	Description	Link
2015-005318-30	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	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.	Other: Placebo
VIB4920 75 mg	Experimental	Participants will receive a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.	Drug: VIB4920
VIB4920 500 mg	Experimental	Participants will receive a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.	Drug: VIB4920
VIB4920 1000 mg	Experimental	Participants will receive a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.	Drug: VIB4920
VIB4920 1500 mg	Experimental	Participants will receive a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.	Drug: VIB4920

Name	Type	Description	Arm Group Labels	Other Names
VIB4920	Drug	Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.	VIB4920 1000 mg VIB4920 1500 mg VIB4920 500 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	Day 1 through Day 169

Secondary Outcomes

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of VIB4920	Maximum observed plasma concentration (Cmax) of VIB4920 is reported.	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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Anniston	Alabama	36207	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31019027	Result	Karnell JL, Albulescu M, Drabic S, Wang L, Moate R, Baca M, Oganesyan V, Gunsior M, Thisted T, Yan L, Li J, Xiong X, Eck SC, de Los Reyes M, Yusuf I, Streicher K, Muller-Ladner U, Howe D, Ettinger R, Herbst R, Drappa J. A CD40L-targeting protein reduces autoantibodies and improves disease activity in patients with autoimmunity. Sci Transl Med. 2019 Apr 24;11(489):eaar6584. doi: 10.1126/scitranslmed.aar6584.

Label	URL
Related Info	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	VIB4920 75 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 29, 2017	Aug 12, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.

Intent-to treat population included all randomized and treated participants, grouped according to assigned treatment.

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
BG002	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
BG003	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
BG004	VIB4920 1500 mg	Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
BG005	Total	Total of all reporting groups

Units	Counts
Participants	BG00015 BG0018 BG00210 BG00312 BG00412 BG00557

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058.3± 8.0 BG00157.9± 7.4 BG00253.7± 9.8 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00014 BG0016 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0012 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

As-treated population included all treated participants, grouped according to actual treatment received.

Posted

Count of Participants

Participants

Day 1 through Day 169

ID	Title	Description
OG000	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.
OG001	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
OG002	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
OG003	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
OG004	VIB4920 1500 mg	Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.

Units	Counts
Participants	OG00015 OG0018 OG00210 OG003

Title

Denominators

Categories

TEAEs

Title	Measurements
	OG00013 OG0013 OG0027 OG003

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.

As-treated population included all treated participants, grouped according to actual treatment received.

Posted

Count of Participants

Participants

Day 1 through Day 169

ID	Title	Description
OG000	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.
OG001	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
OG002	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
OG003	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.

Secondary

Maximum Observed Plasma Concentration (Cmax) of VIB4920

Maximum observed plasma concentration (Cmax) of VIB4920 is reported.

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.

Posted

Mean

Standard Deviation

µg/mL

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

ID	Title	Description
OG000	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
OG001	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
OG002	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
OG003	VIB4920 1500 mg	Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.

Secondary

Time to Maximum Plasma Concentration (Tmax) of VIB4920

Time to maximum plasma concentration (Tmax) of VIB4920 is reported.

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.

Posted

Median

Full Range

Days

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

ID	Title	Description
OG000	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
OG001	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
OG002	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
OG003	VIB4920 1500 mg	Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.

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.

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.

Posted

Mean

Standard Deviation

µg*day/mL

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

ID	Title	Description
OG000	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
OG001	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
OG002	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
OG003	VIB4920 1500 mg

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).

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.

Posted

Mean

Standard Deviation

µg*day/mL/mg

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

ID	Title	Description
OG000	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
OG001	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
OG002	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
OG003	VIB4920 1500 mg

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.

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.

Posted

Mean

Standard Deviation

µg*day/mL

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

ID	Title	Description
OG000	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
OG001	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
OG002	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
OG003	VIB4920 1500 mg

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.

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.

Posted

Mean

Standard Deviation

mL/day

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

ID	Title	Description
OG000	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
OG001	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
OG002	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
OG003	VIB4920 1500 mg	Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.

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.

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.

Posted

Mean

Standard Deviation

Days

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

ID	Title	Description
OG000	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
OG001	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
OG002	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
OG003	VIB4920 1500 mg	Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.

Secondary

Volume of Distribution at Steady State (Vss) of VIB4920

Volume of distribution at steady state (Vss) of VIB4920 is reported.

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.

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
OG001	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
OG002	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
OG003	VIB4920 1500 mg	Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.

Secondary

Accumulation Ratio (AR) of VIB4920

Accumulation ratio of VIB4920 is reported. Accumulation ratio was determined using AUCtau, Dose 7/AUCtau, Dose 1.

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.

Posted

Mean

Standard Deviation

Ratio

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

ID	Title	Description
OG000	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
OG001	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
OG002	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
OG003	VIB4920 1500 mg	Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.

Secondary

Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920

The number of participants with positive antibodies to VIB4920 are reported.

Intent-to treat population included all randomized and treated participants, grouped according to assigned treatment. Participants with available ADA sample were analyzed.

Posted

Count of Participants

Participants

Pre-dose on Days 1, 29, 57, and 85; and on Days 141, and 169

ID	Title	Description
OG000	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
OG001	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
OG002	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
OG003	VIB4920 1500 mg	Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	15	13	15
EG001	VIB4920 75 mg	Participants received a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.	8	0	8	3	8
EG002	VIB4920 500 mg	Participants received a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.	10	0	10	7	10
EG003	VIB4920 1000 mg	Participants received a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.	12	0	12	6	12
EG004	VIB4920 1500 mg	Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.	12	1	12	10	12

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Encephalitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment		EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG0030 events0 affected12 at risk EG0041 events1 affected12 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG0032 events2 affected12 at risk EG0040 events0 affected12 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0013 events2 affected8 at risk EG0021 events1 affected10 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0022 events2 affected10 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0022 events1 affected10 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0026 events2 affected10 at risk EG003
Hot flush	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Oral herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Spinal Pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected8 at risk EG0021 events1 affected10 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Agitation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Blood pressure increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Body temperature increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Cerebral small vessel ischemic disease	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected8 at risk EG0020 events0 affected10 at risk EG003
Cyst	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Dry eye	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Eye irritation	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected8 at risk EG0020 events0 affected10 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Laryngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Leukocyturia	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Localised infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected8 at risk EG0020 events0 affected10 at risk EG003
Lymphangitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Menstruation irregular	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected8 at risk EG0020 events0 affected10 at risk EG003
Nasal herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Peripheral swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected8 at risk EG0020 events0 affected10 at risk EG003
Pulpitis dental	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Salivary duct obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected8 at risk EG0020 events0 affected10 at risk EG003
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Transaminases increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Tremor	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0021 events1 affected10 at risk EG003
Vitamin B12 decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected8 at risk EG0020 events0 affected10 at risk EG003

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Participants received a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.