Back to resultsA Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis (MIDORA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VIB4920
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, RA, VIB4920, MEDI4920
Eligibility Criteria
Principal Inclusion Criteria:
- Male or female adults, >= 18 years of age at time of informed consent.
- Diagnosed with RA according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2010 criteria >= 6 months prior to screening.
- Disease Activity Score in 28 Joints using C-reactive Protein (DAS28-CRP) > 3.2 at screening with >= 4 tender joint count (TJC) and >= 4 swollen joint count (SJC) out of the 28 joints assessed for DAS28 present at screening and confirmed present at visit 2 prior to randomization.
- Positive for RF and/or ACPA at screening, in accordance with criteria at the central laboratory.
- Treated with methotrexate (MTX), with or without a concomitant conventional disease-modifying anti-rheumatic drug (cDMARD).
- Agreeing to use of protocol defined contraception methods.
Principal Exclusion Criteria:
- Prior or current inflammatory joint disease other than RA.
- Severe interstitial lung disease.
- Prior receipt of any biologic B-cell-depleting therapy.
- Receipt of any anti - tumor necrosis factor alpha (TNF-α) biologic agent < 8 weeks prior to screening.
- Receipt of any biologic disease-modifying anti-rheumatic drug (bDMARD) with a mechanism of action other than direct TNF- α blockade, < 12 weeks or < 5 half-lives of the drug prior to screening.
- Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
- Previous treatment with anti-CD40L compounds at any time before randomization.
- Hepatitis B, hepatitis C, or human immunodeficiency virus infection.
- Pregnant or lactating or planning to get pregnant during the duration of the study.
- Evidence of active tuberculosis (TB) or being at high risk for TB.
- History of more than one episode of herpes zoster in the 12 months prior to screening or any opportunistic infection in the 12 months prior to screening, excluding localized mucocutaneous candidiasis.
- Receipt of live vaccine or live therapeutic infectious agent within the 4 weeks prior to screening.
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
VIB4920 1500 mg 4 Times
VIB4920 1500 mg Twice
VIB4920 3000 mg Twice
VIB4920 3000 mg Once
Placebo
Arm Description
Participants receive intravenous (IV) infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57
Participants receive IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
Participants receive IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
Participants receive IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
Participants receive IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
Outcomes
Primary Outcome Measures
Change From Baseline to Day 113 in DAS28-CRP
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity. Results are from a mixed-effect model for repeated measures (MMRM) analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
Adverse event (AE): any untoward medical occurrence associated with the use of an intervention in humans, whether or not it is considered intervention-related. Serious adverse event (SAE): an AE that results in any of the following outcomes: death; life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity; congenital anomaly/birth defect; other important medical event jeopardizing the participant's well-being. AEs of special interest (AESIs) include: thrombotic and embolic events; anaphylaxis and clinically significant (Common Terminology Criteria for Adverse Events [CTCAE] Grade 3 or higher) hypersensitivity reactions; severe infusion-related reactions (CTCAE Grade 3 or higher); immune complex disease; severe (CTCAE Grade 3 or higher) and/or opportunistic infections; hepatic function abnormality meeting the definition of Hy's Law; malignant neoplasm. (CTCAE Grade 3=Severe; Grade 4=Life-threatening; Grade 5=Fatal.)
Secondary Outcome Measures
Pharmacokinetics (PK) of VIB4920: Maximum Observed Concentration (Cmax)
PK of VIB4920: Time to Cmax (Tmax)
PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast)
PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to Day 56 (AUC0-56D)
PK of VIB4920: Total Body Clearance (CL) for Dose 1 and Total Body Clearance at Steady State (CLss) for Doses 2 to 4
PK of VIB4920: Terminal Elimination Half-Life (t1/2)
PK of VIB4920: Volume of Distribution at Steady State (Vss)
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Total sCD40L (free sCD40L and sCD40L bound to VIB4920) was measured in plasma samples using a modified commercially available kit.
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) to VIB4920
ADA positive at any time: observed at least once during the study (baseline included).
Treatment-emergent ADA: ADA positive post-baseline only or boosted pre-existing ADA during the study period.
Persistent positive: treatment-induced ADA positive at ≥ 2 post-baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-baseline assessment.
Transient positive: treatment-induced ADA post-baseline positive but does not fulfill the criteria of persistent positive.
Change From Baseline to Day 113 in Anti-Citrullinated Protein Antibodies (ACPAs)
Excluding data after rescue. Adjusted geometric mean ratio to baseline (90% CI) results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model. Ratios less than 1 indicate a decrease.
Change From Baseline to Day 113 in Rheumatoid Factor (RF)
Excluding data after rescue. Adjusted geometric mean ratio to baseline (90% CI) results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model. Ratios less than 1 indicate a decrease.
Percentage of Participants With Clinical Remission at Day 113
Clinical remission is defined as DAS28-CRP < 2.6. The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity.
Time to Start of New Treatment for Rheumatoid Arthritis (Rescue Medication)
Based on Kaplan-Meier method.
Full Information
NCT ID
NCT04163991
First Posted
November 12, 2019
Last Updated
January 17, 2023
Sponsor
Viela Bio (acquired by Horizon Therapeutics)
1. Study Identification
Unique Protocol Identification Number
NCT04163991
Brief Title
A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis
Acronym
MIDORA
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of VIB4920 in Patients With Rheumatoid Arthritis (RA)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
December 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viela Bio (acquired by Horizon Therapeutics)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of VIB4920 (formerly MEDI4920) in adult participants with rheumatoid arthritis (RA).
Detailed Description
The overall study period will be approximately 337 days. After a screening period of up to 28 days, the participants will be randomized in a 1:1:1:1:1 ratio to receive intravenous dose of VIB4920 and/or placebo in 5 cohorts. Participants are to be followed on their stable background anti-RA therapy at least through 12 weeks (Day 85), at which time rescue therapy may be instituted. All participants will be followed at least through the primary (interim) analysis (Day 113), and those who have not instituted rescue therapy will be followed through Day 309 to determine the duration of clinical response. The primary analysis will be after all participants have completed Day 113, and the final analysis will be after all participants have completed follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, RA, VIB4920, MEDI4920
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIB4920 1500 mg 4 Times
Arm Type
Experimental
Arm Description
Participants receive intravenous (IV) infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57
Arm Title
VIB4920 1500 mg Twice
Arm Type
Experimental
Arm Description
Participants receive IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
Arm Title
VIB4920 3000 mg Twice
Arm Type
Experimental
Arm Description
Participants receive IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
Arm Title
VIB4920 3000 mg Once
Arm Type
Experimental
Arm Description
Participants receive IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
Intervention Type
Drug
Intervention Name(s)
VIB4920
Other Intervention Name(s)
MEDI4920, dazodalibep
Intervention Description
liquid for IV infusion following dilution in normal saline
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9% saline for IV infusion
Primary Outcome Measure Information:
Title
Change From Baseline to Day 113 in DAS28-CRP
Description
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity. Results are from a mixed-effect model for repeated measures (MMRM) analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.
Time Frame
Day 1 (Baseline), Day 113
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
Description
Adverse event (AE): any untoward medical occurrence associated with the use of an intervention in humans, whether or not it is considered intervention-related. Serious adverse event (SAE): an AE that results in any of the following outcomes: death; life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity; congenital anomaly/birth defect; other important medical event jeopardizing the participant's well-being. AEs of special interest (AESIs) include: thrombotic and embolic events; anaphylaxis and clinically significant (Common Terminology Criteria for Adverse Events [CTCAE] Grade 3 or higher) hypersensitivity reactions; severe infusion-related reactions (CTCAE Grade 3 or higher); immune complex disease; severe (CTCAE Grade 3 or higher) and/or opportunistic infections; hepatic function abnormality meeting the definition of Hy's Law; malignant neoplasm. (CTCAE Grade 3=Severe; Grade 4=Life-threatening; Grade 5=Fatal.)
Time Frame
From first dose of study drug through Day 309 ± 7 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) of VIB4920: Maximum Observed Concentration (Cmax)
Time Frame
Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7d
Title
PK of VIB4920: Time to Cmax (Tmax)
Time Frame
Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7d
Title
PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast)
Time Frame
Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7d
Title
PK of VIB4920: Area Under the Concentration-Time Curve From Time 0 to Day 56 (AUC0-56D)
Time Frame
Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), Day 56
Title
PK of VIB4920: Total Body Clearance (CL) for Dose 1 and Total Body Clearance at Steady State (CLss) for Doses 2 to 4
Time Frame
Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7d
Title
PK of VIB4920: Terminal Elimination Half-Life (t1/2)
Time Frame
Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7d
Title
PK of VIB4920: Volume of Distribution at Steady State (Vss)
Time Frame
Predose (within 30 minutes prior to start of infusion), and within 10 minutes of the end of infusion on Days 1 (Dose 1), 15 ± 1 day (d; Dose 2), 29 ± 3d (Dose 3), 57 ± 3d (Dose 4), and Days 85 ± 3d, 113 ± 5d, 141 ± 5d, 169 ± 5d, 197 ± 7d, 225 ± 7d
Title
Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time
Description
Total sCD40L (free sCD40L and sCD40L bound to VIB4920) was measured in plasma samples using a modified commercially available kit.
Time Frame
Day 1 (Baseline), Days 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309
Title
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) to VIB4920
Description
ADA positive at any time: observed at least once during the study (baseline included).
Treatment-emergent ADA: ADA positive post-baseline only or boosted pre-existing ADA during the study period.
Persistent positive: treatment-induced ADA positive at ≥ 2 post-baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-baseline assessment.
Transient positive: treatment-induced ADA post-baseline positive but does not fulfill the criteria of persistent positive.
Time Frame
Day 1 (Baseline) to Day 309 Day 1 (Baseline) up to Day 309 (± 7 days)
Title
Change From Baseline to Day 113 in Anti-Citrullinated Protein Antibodies (ACPAs)
Description
Excluding data after rescue. Adjusted geometric mean ratio to baseline (90% CI) results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model. Ratios less than 1 indicate a decrease.
Time Frame
Day 1 (Baseline), Day 113
Title
Change From Baseline to Day 113 in Rheumatoid Factor (RF)
Description
Excluding data after rescue. Adjusted geometric mean ratio to baseline (90% CI) results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model. Ratios less than 1 indicate a decrease.
Time Frame
Day 1 (Baseline), Day 113
Title
Percentage of Participants With Clinical Remission at Day 113
Description
Clinical remission is defined as DAS28-CRP < 2.6. The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity.
Time Frame
Day 113
Title
Time to Start of New Treatment for Rheumatoid Arthritis (Rescue Medication)
Description
Based on Kaplan-Meier method.
Time Frame
Day 1 (Baseline) up to Day 309 (± 7 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Principal Inclusion Criteria:
Male or female adults, >= 18 years of age at time of informed consent.
Diagnosed with RA according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2010 criteria >= 6 months prior to screening.
Disease Activity Score in 28 Joints (DAS 28) using C-reactive Protein (DAS28-CRP) > 3.2 at screening with >= 4 tender joint count (TJC) and >= 4 swollen joint count (SJC) out of the 28 joints assessed for DAS28 present at screening and confirmed present at visit 2 prior to randomization.
Positive for rheumatoid factor (RF) and/or anti-citrullinated protein antibodies (ACPA) at screening, in accordance with criteria at the central laboratory.
Treated with methotrexate (MTX), with or without a concomitant conventional disease-modifying anti-rheumatic drug (cDMARD).
Agreeing to use of protocol defined contraception methods.
Principal Exclusion Criteria:
Prior or current inflammatory joint disease other than RA.
Severe interstitial lung disease.
Prior receipt of any biologic B-cell-depleting therapy.
Receipt of any anti - tumor necrosis factor alpha (TNF-α) biologic agent < 8 weeks prior to screening.
Receipt of any biologic disease-modifying anti-rheumatic drug (bDMARD) with a mechanism of action other than direct TNF-α blockade, < 12 weeks or < 5 half-lives of the drug prior to screening.
Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
Previous treatment with anti-cluster of differentiation 40 ligand (CD40L) compounds at any time before randomization.
Hepatitis B, hepatitis C, or human immunodeficiency virus infection.
Pregnant or lactating or planning to get pregnant during the duration of the study.
Evidence of active tuberculosis (TB) or being at high risk for TB.
History of more than one episode of herpes zoster in the 12 months prior to screening or any opportunistic infection in the 12 months prior to screening, excluding localized mucocutaneous candidiasis.
Receipt of live vaccine or live therapeutic infectious agent within the 4 weeks prior to screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilias Alevizos, PhD, DMD
Organizational Affiliation
Horizon Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Research Site
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Research Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Research Site
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Research Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Research Site
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Research Site
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Research Site
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Research Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Research Site
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377
Country
United States
Facility Name
Research Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Research Site
City
Baytown
State/Province
Texas
ZIP/Postal Code
77477
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
Nadarzyn
State/Province
Mazowieckie
Country
Poland
Facility Name
Research Site
City
Siedlce
State/Province
Mazowieckie
Country
Poland
Facility Name
Research Site
City
Krakow
State/Province
Małopolskie
Country
Poland
Facility Name
Research Site
City
Bialystok
State/Province
Podlaskie
Country
Poland
Facility Name
Research Site
City
Elblag
State/Province
Warmińsko-mazurskie
Country
Poland
Facility Name
Research Site
City
Poznan
State/Province
Wielkopolskie
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis
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