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
Last Update Posted : February 16, 2022
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Condition or disease | Intervention/treatment | Phase |
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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 Dose1 (dosing interval 1)
Participants will receive intravenous (IV) infusion of VIB4920 Dose1 in dosing interval 1.
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Drug: VIB4920
VIB4920 Dose 1 or 2 will be administered intravenously per dosing interval of 1 or 2 or 4.
Other Name: MEDI4920 |
Experimental: VIB4920 Dose1 (dosing interval 2)+Placebo (dosing interval 3)
Participants will receive IV infusion of VIB4920 Dose1 in dosing interval 2 and placebo matched to VIB4920 in dosing interval 3.
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Drug: VIB4920
VIB4920 Dose 1 or 2 will be administered intravenously per dosing interval of 1 or 2 or 4.
Other Name: MEDI4920 Drug: Placebo Placebo will be administered intravenously per dosing interval of 1 or 3 or 5. |
Experimental: VIB4920 Dose2 (dosing interval 2)+Placebo (dosing interval 3)
Participants will receive IV infusion of VIB4920 Dose2 in dosing interval 2 and placebo matched to VIB4920 in dosing interval 3.
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Drug: VIB4920
VIB4920 Dose 1 or 2 will be administered intravenously per dosing interval of 1 or 2 or 4.
Other Name: MEDI4920 Drug: Placebo Placebo will be administered intravenously per dosing interval of 1 or 3 or 5. |
Experimental: VIB4920 Dose2 (dosing interval 4)+Placebo (dosing interval 5)
Participants will receive IV infusion of VIB4920 Dose2 in dosing interval 4 and placebo matched to VIB4920 in dosing interval 5.
|
Drug: VIB4920
VIB4920 Dose 1 or 2 will be administered intravenously per dosing interval of 1 or 2 or 4.
Other Name: MEDI4920 Drug: Placebo Placebo will be administered intravenously per dosing interval of 1 or 3 or 5. |
Placebo Comparator: Placebo (dosing interval 1)
Participants will receive IV infusion of placebo matched to VIB4920 in dosing interval 1.
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Drug: Placebo
Placebo will be administered intravenously per dosing interval of 1 or 3 or 5. |
- Change From Baseline to Day 113 in Disease Activity Score in 28 Joints Using C-reactive Protein (DAS28-CRP) (range: 1-10; higher score is worse outcome) [ Time Frame: Day 1 (Baseline) through Day 113 ]
- 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: Day 1 (Baseline) through Day 309 ]
- Plasma Concentration of VIB4920 [ Time Frame: Day 1 to Day 225 ]
- Total Soluble Cluster of Differentiation 40 (sCD40L) Plasma Concentration [ Time Frame: Day 1 (Baseline) through Day 309 ]
- Percentage of Participants With Positive Anti-drug Antibodies (ADA) Titre to VIB4920 [ Time Frame: Day 1 (Baseline) to Day 309 ]
- Change in Rheumatoid Factor (RF) From Baseline to Day 113 [ Time Frame: Day 1 (Baseline) through Day 113 ]
- Change in Anti-citrullinated Protein Antibodies (ACPAs) From Baseline to Day 113 [ Time Frame: Day 1 (Baseline) through Day 113 ]
- Percentage of Participants With Clinical Remission at Day 113 [ Time Frame: Day 113 ]
- Time to Start of New Treatment for RA [ Time Frame: Day 1 (Baseline) through Day 309 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 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.

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 | |
Research Site | |
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 | |
Research Site | |
Atlanta, Georgia, United States, 30342 | |
United States, Kentucky | |
Research Site | |
Lexington, Kentucky, United States, 40504 | |
United States, Maryland | |
Research Site | |
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: | Gabor Illei, PhD, MD, MHS | Viela Bio |
Responsible Party: | Viela Bio |
ClinicalTrials.gov Identifier: | NCT04163991 |
Other Study ID Numbers: |
VIB4920.P2.S3 2019-003697-70 ( EudraCT Number ) |
First Posted: | November 15, 2019 Key Record Dates |
Last Update Posted: | February 16, 2022 |
Last Verified: | February 2022 |
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 |