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    Summary
    EudraCT Number:2019-003697-70
    Sponsor's Protocol Code Number:VIB4920.P2.S3
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-12-06
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-003697-70
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at the effectiveness and safety of test product VIB4920 in
    subjects with Rheumatoid Arthritis (RA)
    A.3.2Name or abbreviated title of the trial where available
    MIDORA
    A.4.1Sponsor's protocol code numberVIB4920.P2.S3
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorViela Bio, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportViela Bio, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationViela Bio, Inc.
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post codeMD 20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1249558 0038
    B.5.5Fax number+1301841 8424
    B.5.6E-mailclinicaltrials@vielabio.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVIB4920
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.1CAS number 2245953-10-8
    D.3.9.2Current sponsor codeVIB4920
    D.3.9.3Other descriptive nameMEDI4920
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the effect of VIB4920 on disease activity as assessed by a composite measure in subjects with adult-onset RA.
    • To evaluate the safety and tolerability of VIB4920 in subjects with adult-onset RA.
    E.2.2Secondary objectives of the trial
    • To characterize the pharmacokinetics (PK) of VIB4920 in subjects with adult-onset RA
    • To evaluate the pharmacodynamic effect of VIB4920 in subjects with adult-onset RA
    • To evaluate the immunogenicity of VIB4920 in subjects with adult-onset RA
    • To evaluate the effect of VIB4920 on autoantibodies in subjects with adult-onset RA
    • To assess the effect of VIB4920 on clinical remission as assessed by a composite measure in subjects with adult-onset RA
    • To evaluate the duration of clinical response to VIB4920 as assessed by time to institution of rescue therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be included in the study, each individual must satisfy all the following criteria:
    1. Male or female adults, ≥ 18 years of age at time of informed consent.
    2. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
    3. Diagnosed with Rheumatoid Arthritis (RA) according to the European League Against Rheumatism / American College of Rheumatology (EULAR/ACR) 2010 criteria ≥ 6 months prior to screening.
    4. 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.
    5. Positive for rheumatoid factor (RF) and/or anti-citrullinated protein antibodies (ACPA) at screening, in accordance with criteria at the central laboratory.
    6. Treated with methotrexate (MTX) given orally, subcutaneous (SC), or intramuscularly at a dose of 7.5-25.0 mg/week, with or without a concomitant disease-modifying anti-rheumatic drug (cDMARD) other than leflunomide, with MTX and the cDMARD delivered by the same route for ≥ 12 weeks without change in dose for ≥ 6 weeks prior to screening, OR, if MTX intolerant or if MTX is contraindicated, treated with one or more cDMARD for ≥ 12 weeks without change in dose for ≥ 6 weeks prior to screening. (Janus kinase (JAK) inhibitors are not considered cDMARDs).
    7. Willing and able to comply with the protocol, complete study assessments, and complete the study period.
    8. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception from signing informed consent and must agree to continue using such precautions through the end of the follow-up of the study; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. A recommendation that the female partners (of childbearing potential) of male study participants should use a highly effective method of contraception other than a barrier method will be made.
    a. Females of childbearing potential are defined as those who are not surgically sterile (ie, surgical sterilization includes bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or those who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause and a follicle-stimulating hormone within the postmenopausal range as established by the clinical laboratory).
    b. Because some of the background medications used in RA and accepted in the current study (eg, MTX or leflunomide) are known to have potential deleterious effects on conception, pregnancy, and fetal health, the Investigator must inform the subjects about these risks and should manage every case of planned conception or pregnancy according to the local medical practice standards.
    c. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from Day 1 through to the end of the study.
    E.4Principal exclusion criteria
    Any of the following excludes an individual from participation in the study:
    1. Prior or current (1) inflammatory joint disease other than RA; (2) other systemic autoimmune disorder or polymyalgia rheumatica except that patients with RA and secondary Sjögren’s syndrome may enroll.
    2. Severe interstitial lung disease.
    3. Prior receipt of any biologic B-cell-depleting therapy.
    4. Receipt of any anti-TNFα biologic agent < 8 weeks prior to screening.
    5. Receipt of any biological (b) DMARD with a mechanism of action other than direct TNF blockade, including any JAK inhibitor, <12 weeks or <5 half-lives of the drug (whichever is longer) prior to screening.
    6. Receipt of any experimental therapy <12 weeks or <5 half-lives of the drug (whichever is longer) prior to screening.
    7. Injectable corticosteroids (including intraarticular) or treatment with >10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening. Concomitant treatment with oral corticosteroids ≤10 mg/day prednisone or equivalent is permitted provided that the dose is stable for ≥4 weeks prior to screening and during the screening period and is expected to remain stable for the duration of the treatment period. Inhaled or topical corticosteroids given for asthma, chronic obstructive pulmonary disease, or dermatological conditions are allowed, provided doses are expected to be stable during the study.
    8. Previous treatment with anti-CD40L compounds at any time before randomization.
    9. History of confirmed deep venous thrombosis or arterial thromboembolism within 2 years of enrollment OR history of recurrent deep venous thrombosis or arterial thromboembolism OR patients with risk factors for venous thromboembolism or arterial thrombosis, prothrombotic status (including, but not limited to, known congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of catastrophic antiphospholipid syndrome).
    10. Treatment with anticoagulant drugs. Low-dose aspirin treatment (up to 325 mg/day) is allowed.
    11. History of solid organ or cell-based transplantation.
    12. Active malignancy or history of malignancy that was active within the last 15 years, with exceptions as defined in the protocol.
    13. Pregnancy, lactation, or planning to become pregnant during the duration of the study.
    14. Positive test for, or prior treatment for, hepatitis B, hepatitis C, or HIV infection. A positive test for hepatitis B is detection of either (1) hepatitis B surface antigen (HBsAg); or (2) hepatitis B core antibody (anti-HBc).
    15. Evidence of active tuberculosis (TB) or being at high risk for TB based on criteria defined in the protocol.
    16. History of (a) more than one episode of herpes zoster in the 12 months prior to screening or (b) any opportunistic infection in the 12 months prior to screening, excluding localized mucocutaneous candidiasis.
    17. Known history of severe allergy or reaction to any component of the IP formulation.
    18. Severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder or any other condition that, in the opinion of the Investigator, would place the patient at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of patient safety or study results.Subjects should be assessed for epidemiologic risk of COVID-19 (recent
    exposures, high-risk housing) and for health-related risk of COVID-19
    severity based on current understanding of risk factors for severe
    disease when making a decision regarding the individual subject's risk of
    participation. Subjects who have active COVID-19 infection or disease or
    other significant infection, or, in the judgment of the investigator, who
    may be at unacceptable risk of COVID-19 or its complications should not
    be randomized.
    Ensure that the subject has a documented negative SARS-CoV-2 test
    within two weeks prior to randomization. Subjects with a positive test
    for SARS-CoV-2 may be rescreened at least 2 weeks after a positive test
    if asymptomatic and at least 3 weeks after symptomatic COVID-19
    illness.
    19. Inflammatory osteoarthritis.
    20. Receipt of live vaccine or live therapeutic infectious agent within the 4 weeks prior to screening.
    21. Blood tests at screening that meet any of the criteria defined in the protocol.
    22. History of alcohol or drug abuse that, in the opinion of the Investigator, might affect patient safety or compliance with visits, or interfere with safety or other study assessments.

    Repeat of screening laboratory tests: Repeat of study safety laboratory tests is acceptable if initial screening result is outside of acceptable limits; repeat tests must be conducted in line with the parameters defined in the protocol.
    Rescreening Procedures: Patients may be rescreened once if, in the Investigator’s judgment, the reason for ineligibility is likely to have resolved at the time of rescreening.
    E.5 End points
    E.5.1Primary end point(s)
    • Change in DAS28-CRP from baseline to Day 113
    • The incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events and TEAEs of special interest during the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Change in DAS28-CRP: baseline to Study day 113
    • TEAEs/ TEAEs of special interest: baseline to Study day 309 or early discontinuation visit
    E.5.2Secondary end point(s)
    • The PK profile of VIB4920
    • The time-concentration profile of total soluble CD40L
    • The proportion of subjects with anti-drug antibodies to VIB4920
    • Change in RF and ACPAs from baseline to Day 113
    • The proportion of subjects with clinical remission defined as DAS28-CRP < 2.6 at Day 113
    • Time to start of new treatment for RA (rescue medication)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • PK: Study day 1 to day 225
    • The time-concentration profile of total soluble CD40L: through study duration
    • Anti-drug antibodies to VIB4920: Study days 1, 15, 29, 85, 169, 253 and 309 (or early discontinuation visit)
    • Change in RF and ACPAs: baseline to study Day 113
    • DAS28-CRP < 2.6: at study day 113
    • Treatment for RA (rescue medication): through study duration
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Poland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study will be completed once the last active subject has completed all assessments listed for Visit 14 (Day 309 ± 7 days).
    If the last active subject has received rescue therapy, the study will end when that subject completes participation according to the procedures described in the protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 75
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-13
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