A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis (MIDORA)
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ClinicalTrials.gov Identifier: NCT04163991 |
Recruitment Status :
Completed
First Posted : November 15, 2019
Results First Posted : February 14, 2023
Last Update Posted : February 14, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: VIB4920 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 78 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | December 9, 2019 |
Actual Primary Completion Date : | December 28, 2021 |
Actual Study Completion Date : | December 28, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: VIB4920 1500 mg 4 Times
Participants receive intravenous (IV) infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57
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Drug: VIB4920
liquid for IV infusion following dilution in normal saline
Other Names:
|
Experimental: VIB4920 1500 mg Twice
Participants receive IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.
|
Drug: VIB4920
liquid for IV infusion following dilution in normal saline
Other Names:
Drug: Placebo 0.9% saline for IV infusion |
Experimental: VIB4920 3000 mg Twice
Participants receive IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.
|
Drug: VIB4920
liquid for IV infusion following dilution in normal saline
Other Names:
Drug: Placebo 0.9% saline for IV infusion |
Experimental: VIB4920 3000 mg Once
Participants receive IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.
|
Drug: VIB4920
liquid for IV infusion following dilution in normal saline
Other Names:
Drug: Placebo 0.9% saline for IV infusion |
Placebo Comparator: Placebo
Participants receive IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.
|
Drug: Placebo
0.9% saline for IV infusion |
- Change From Baseline to Day 113 in DAS28-CRP [ Time Frame: Day 1 (Baseline), Day 113 ]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) [ Time Frame: From first dose of study drug through Day 309 ± 7 days ]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.)
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Total Soluble Cluster of Differentiation 40 Ligand (sCD40L) Plasma Concentration Over Time [ Time Frame: Day 1 (Baseline), Days 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309 ]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 [ Time Frame: Day 1 (Baseline) to Day 309 Day 1 (Baseline) up to Day 309 (± 7 days) ]
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) [ Time Frame: Day 1 (Baseline), Day 113 ]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) [ Time Frame: Day 1 (Baseline), Day 113 ]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 [ Time Frame: 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) [ Time Frame: Day 1 (Baseline) up to Day 309 (± 7 days) ]Based on Kaplan-Meier method.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04163991
United States, Alabama | |
Research Site | |
Anniston, Alabama, United States, 36207 | |
United States, Arizona | |
Research Site | |
Sun City, Arizona, United States, 85704 | |
United States, California | |
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Upland, California, United States, 91786 | |
United States, Florida | |
Research Site | |
Clearwater, Florida, United States, 33765 | |
Research Site | |
Margate, Florida, United States, 33063 | |
Research Site | |
Miami Lakes, Florida, United States, 33014 | |
Research Site | |
Zephyrhills, Florida, United States, 33542 | |
United States, Georgia | |
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Atlanta, Georgia, United States, 30342 | |
United States, Kentucky | |
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Lexington, Kentucky, United States, 40504 | |
United States, Maryland | |
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Wheaton, Maryland, United States, 20902 | |
United States, North Carolina | |
Research Site | |
Charlotte, North Carolina, United States, 28210 | |
Research Site | |
Rocky Mount, North Carolina, United States, 27804 | |
Research Site | |
Salisbury, North Carolina, United States, 28144 | |
United States, Ohio | |
Research Site | |
Vandalia, Ohio, United States, 45377 | |
United States, Oklahoma | |
Research Site | |
Norman, Oklahoma, United States, 73069 | |
United States, Pennsylvania | |
Research Site | |
Duncansville, Pennsylvania, United States, 16635 | |
United States, Texas | |
Research Site | |
Baytown, Texas, United States, 77477 | |
Research Site | |
Dallas, Texas, United States, 75231 | |
Poland | |
Research Site | |
Nadarzyn, Mazowieckie, Poland | |
Research Site | |
Siedlce, Mazowieckie, Poland | |
Research Site | |
Krakow, Małopolskie, Poland | |
Research Site | |
Bialystok, Podlaskie, Poland | |
Research Site | |
Elblag, Warmińsko-mazurskie, Poland | |
Research Site | |
Poznan, Wielkopolskie, Poland | |
Research Site | |
Warszawa, Poland |
Study Director: | Ilias Alevizos, PhD, DMD | Horizon Therapeutics |
Documents provided by Viela Bio (acquired by Horizon Therapeutics):
Responsible Party: | Viela Bio (acquired by Horizon Therapeutics) |
ClinicalTrials.gov Identifier: | NCT04163991 |
Other Study ID Numbers: |
VIB4920.P2.S3 2019-003697-70 ( EudraCT Number ) |
First Posted: | November 15, 2019 Key Record Dates |
Results First Posted: | February 14, 2023 |
Last Update Posted: | February 14, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Rheumatoid Arthritis RA VIB4920 MEDI4920 |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |