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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 : Active, not recruiting
First Posted : November 15, 2019
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Viela Bio

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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: VIB4920 Drug: Placebo Phase 2

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-rheumatoid arthritis (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.

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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
Estimated Primary Completion Date : December 13, 2021
Estimated Study Completion Date : December 13, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VIB4920 Dose1 (dosing interval 1)
Participants will receive intravenous (IV) infusion of VIB4920 Dose1 in dosing interval 1.
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.
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.
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.
Drug: Placebo
Placebo will be administered intravenously per dosing interval of 1 or 3 or 5.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Plasma Concentration of VIB4920 [ Time Frame: Day 1 to Day 225 ]
  2. Total Soluble Cluster of Differentiation 40 (sCD40L) Plasma Concentration [ Time Frame: Day 1 (Baseline) through Day 309 ]
  3. Percentage of Participants With Positive Anti-drug Antibodies (ADA) Titre to VIB4920 [ Time Frame: Day 1 (Baseline) to Day 309 ]
  4. Change in Rheumatoid Factor (RF) From Baseline to Day 113 [ Time Frame: Day 1 (Baseline) through Day 113 ]
  5. Change in Anti-citrullinated Protein Antibodies (ACPAs) From Baseline to Day 113 [ Time Frame: Day 1 (Baseline) through Day 113 ]
  6. Percentage of Participants With Clinical Remission at Day 113 [ Time Frame: Day 113 ]
  7. Time to Start of New Treatment for RA [ Time Frame: Day 1 (Baseline) through Day 309 ]


Information from the National Library of Medicine

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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
Criteria

Principal Inclusion Criteria:

  1. Male or female adults, >= 18 years of age at time of informed consent.
  2. Diagnosed with RA according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2010 criteria >= 6 months prior to screening.
  3. 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.
  4. Positive for RF and/or ACPA at screening, in accordance with criteria at the central laboratory.
  5. Treated with methotrexate (MTX), with or without a concomitant conventional disease-modifying anti-rheumatic drug (cDMARD).
  6. Agreeing to use of protocol defined contraception methods.

Principal Exclusion Criteria:

  1. Prior or current inflammatory joint disease other than RA.
  2. Severe interstitial lung disease.
  3. Prior receipt of any biologic B-cell-depleting therapy.
  4. Receipt of any anti - tumor necrosis factor alpha (TNF-α) biologic agent < 8 weeks prior to screening.
  5. 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.
  6. Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
  7. Previous treatment with anti-CD40L compounds at any time before randomization.
  8. Hepatitis B, hepatitis C, or human immunodeficiency virus infection.
  9. Pregnant or lactating or planning to get pregnant during the duration of the study.
  10. Evidence of active tuberculosis (TB) or being at high risk for TB.
  11. 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.
  12. Receipt of live vaccine or live therapeutic infectious agent within the 4 weeks prior to screening.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Viela Bio
Investigators
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Study Director: Anthony Barbieri, MD Viela Bio
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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: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viela Bio:
Rheumatoid Arthritis
RA
VIB4920
MEDI4920
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases