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MIDORA: A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis

Sponsor
Viela Bio (Industry)
Overall Status
Completed
CT.gov ID
NCT04163991
Collaborator
(none)
78
Enrollment
25
Locations
5
Arms
24.6
Actual Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
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 :
Dec 9, 2019
Actual Primary Completion Date :
Dec 28, 2021
Actual Study Completion Date :
Dec 28, 2021

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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.

    Outcome Measures

    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) [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) [Day 1 (Baseline) through Day 309]

    Secondary Outcome Measures

    1. Plasma Concentration of VIB4920 [Day 1 to Day 225]

    2. Total Soluble Cluster of Differentiation 40 (sCD40L) Plasma Concentration [Day 1 (Baseline) through Day 309]

    3. Percentage of Participants With Positive Anti-drug Antibodies (ADA) Titre to VIB4920 [Day 1 (Baseline) to Day 309]

    4. Change in Rheumatoid Factor (RF) From Baseline to Day 113 [Day 1 (Baseline) through Day 113]

    5. Change in Anti-citrullinated Protein Antibodies (ACPAs) From Baseline to Day 113 [Day 1 (Baseline) through Day 113]

    6. Percentage of Participants With Clinical Remission at Day 113 [Day 113]

    7. Time to Start of New Treatment for RA [Day 1 (Baseline) through Day 309]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Anniston Alabama United States 36207
    2 Research Site Sun City Arizona United States 85704
    3 Research Site Upland California United States 91786
    4 Research Site Clearwater Florida United States 33765
    5 Research Site Margate Florida United States 33063
    6 Research Site Miami Lakes Florida United States 33014
    7 Research Site Zephyrhills Florida United States 33542
    8 Research Site Atlanta Georgia United States 30342
    9 Research Site Lexington Kentucky United States 40504
    10 Research Site Wheaton Maryland United States 20902
    11 Research Site Charlotte North Carolina United States 28210
    12 Research Site Rocky Mount North Carolina United States 27804
    13 Research Site Salisbury North Carolina United States 28144
    14 Research Site Vandalia Ohio United States 45377
    15 Research Site Norman Oklahoma United States 73069
    16 Research Site Duncansville Pennsylvania United States 16635
    17 Research Site Baytown Texas United States 77477
    18 Research Site Dallas Texas United States 75231
    19 Research Site Nadarzyn Mazowieckie Poland
    20 Research Site Siedlce Mazowieckie Poland
    21 Research Site Krakow Małopolskie Poland
    22 Research Site Bialystok Podlaskie Poland
    23 Research Site Elblag Warmińsko-mazurskie Poland
    24 Research Site Poznan Wielkopolskie Poland
    25 Research Site Warszawa Poland

    Sponsors and Collaborators

    • Viela Bio

    Investigators

    • Study Director: Gabor Illei, PhD, MD, MHS, Viela Bio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Viela Bio
    ClinicalTrials.gov Identifier:
    NCT04163991
    Other Study ID Numbers:
    • VIB4920.P2.S3
    • 2019-003697-70
    First Posted:
    Nov 15, 2019
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Feb 16, 2022