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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-000949-14
    Sponsor's Protocol Code Number:VIB0551.P3.S1
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-10-08
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2020-000949-14
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,
    PLACEBO-CONTROLLED PHASE 3 STUDY WITH
    OPEN-LABEL PERIOD TO EVALUATE THE EFFICACY
    AND SAFETY OF INEBILIZUMAB IN ADULTS WITH
    MYASTHENIA GRAVIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Inebilizumab efficacy and safety in adults with myasthenia gravis
    A.3.2Name or abbreviated title of the trial where available
    Myasthenia Gravis INebilizumab Trial (MINT)
    A.4.1Sponsor's protocol code numberVIB0551.P3.S1
    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 Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressOne Medimmune Way
    B.5.3.2Town/ cityGaithersburg, Maryland
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number0012405580038
    B.5.5Fax number0012407729578
    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 nameInebilizumab
    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 INNINEBILIZUMAB
    D.3.9.2Current sponsor codeVIB0551
    D.3.9.3Other descriptive nameCD19-directed humanised afucosylated monoclonal antibody
    D.3.9.4EV Substance CodeSUB189141
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeInebilizumab is a CD19-directed humanised, afucosylated IgG1 monoclonal antibody.
    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 placeboConcentrate for solution 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
    Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK).
    E.1.1.1Medical condition in easily understood language
    Myasthenia gravis (MG) is a rare autoimmune disorder, caused by binding of antibodies to the acetylcholine receptor (AChR) or functionally related molecules on the postsynaptic neuromuscular junction.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10028417
    E.1.2Term Myasthenia gravis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether inebilizumab can reduce MG-related
    disability.
    E.2.2Secondary objectives of the trial
    - To evaluate whether inebilizumab can reduce the frequency of MG exacerbations.
    - To evaluate whether inebilizumab can improve MG-related quality of life.
    - To evaluate the safety and tolerability of inebilizumab in MG.
    - To characterize the pharmacokinetic (PK) profile and immunogenicity of inebilizumab in patients with MG.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Diagnosis of MG with anti-AChR or anti-MuSK antibody.
    3. MGFA Clinical Classification Class II, III, or IV.
    4. MG-ADL score of 6 or greater at screening and at randomization with >50% of this score attributed to non-ocular items.
    5. QMG score of 11 or greater.
    6. Subjects must be on:
    a. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
    b. One allowed non-steroidal IST, with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or
    c. Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed nonsteroidal IST with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.
    Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.
    7. Females of childbearing potential who are sexually active with a nonsterilized
    male partner must use at least one highly effective
    contraception method from the time of screening and for 6 months after
    the final dose of IP. Periodic abstinence, the rhythm method, and the
    withdrawal method are not acceptable methods of contraception.
    8. Non-sterilized males who are sexually active with a female partner of
    childbearing potential must use a condom from Day 1 for the duration of
    the study and for 3 months after the last dose of IP. Because male
    condom is not a highly effective contraception method, it is strongly
    recommended that female partners of a male study subject also use a
    highly effective method of contraception throughout this period
    E.4Principal exclusion criteria
    1.Lactating or pregnant females, or females who intend to become pregnant anytime from signing the informed consent form (ICF) throughout the RCP plus 6 months following last dose of IP.
    2.Known immunodeficiency disorder, including human immunodeficiency virus (HIV) infection.
    3.Thymectomy within ≤ 12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the RCP.
    4.Receipt of the following medications or treatments at any time prior to randomization:
    a.Alemtuzumab (Lemtrada®, Campath®)
    b.Total lymphoid irradiation
    c.Bone marrow transplant
    d.T-cell vaccination therapy
    e.Natalizumab (Tysabri®)
    5.Receipt of rituximab (MabThera®, Rituxan®), ocrelizumab (Ocrevus®), ofatumumab (Arzerra®), obinutuzumab (Gazyva®), inebilizumab, or any experimental B-cell depleting agent within the 6 months prior to Day 1, unless the subject has a CD19+ B-cell count ≥ 40 cells/µL  according to the central laboratory at screening.
    6.Receipt within the 3 months prior to Day 1:
    a.Tocilizumab (Actemra®)
    b.Belimumab (Benlysta®)
    c.Eculizumab (Soliris®)
    d.Cyclophosphamide (Cytoxan®)
    7.Receipt within the 4 weeks prior to Day 1:
    a.Cyclosporine (except eye drops)
    b.Tacrolimus (except topical)
    c.Methotrexate
    d.Intravenous immunoglobulin (IVIg)
    e.Plasma exchange (PLEX) treatment
    8.Current use of:
    a.Prednisone > 40 mg/day or > 80 mg over a 2-day period (or equivalent dose of other corticosteroids)
    b.Pyridostigmine > 480 mg/day or unstable dose in the 2 weeks prior to Day 1
    c.Azathioprine > 3 mg/kg/day
    d.Mycophenolate mofetil > 3 g/day or mycophenolic acid > 1440 mg/day
    9.Receipt of a live attenuated vaccine within 4 weeks prior to randomization. Administration of inactivated (killed) vaccines is acceptable.
    10.Unresected thymoma (Note: subjects with a benign thymoma resected > 1 year prior to screening may enroll. Benign is defined as no known metastases and no extension into or beyond the capsule on pathological examination. Imaging to evaluate for thymoma must have been performed prior to randomization per standard of care).
    11.History of cancer, except for the following:
    a.In situ carcinoma of the cervix treated with apparent success with curative therapy for > 12 months prior to screening
    b.Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapy for > 12 months prior to screening
    c.Prostate cancer treated with radical prostatectomy or radiation therapy with curative intent > 3 years prior to screening and without known recurrence or current treatment
    d.Malignant thymoma resected > 5 years prior to screening with no evidence of active disease and no therapy received over the previous 5 years.
    12.Any of the following laboratory abnormalities at screening (one repeat test may be conducted to confirm results prior to randomization within the same screening period):
    a.Elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN)).
    b.Total bilirubin > 1.5 × ULN (unless due to Gilbert’s syndrome)
    c.Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2
    d.CD19+ B-cell count < 40 cells/µL
    e.Absolute neutrophil count (ANC) < 1.2 × 103 cells/µl
    f.Platelet count < 75,000/μL (or < 75 × 109/L)
    g.Hemoglobin < 8.0 g/dL
    h.Total immunoglobulin < 600 mg/dL
    13.Positive test for chronic hepatitis B infection at screening, defined as either (1) positive hepatitis B surface antigen (HBsAg) or (2) a positive hepatitis B core antibody (anti‑HBc) PLUS negative hepatitis B surface antibody (anti-HBs).
    Note: Subjects with a positive anti-HBs only, or a positive anti-HBc plus positive anti‑HBs and negative HBsAg, are eligible to enroll.
    14.Positive test for hepatitis C virus antibody.
    15.Positive HIV test.
    16.History of active or latent tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless treatment for tuberculosis was completed per local guidelines. Subjects with latent TB or a positive QuantiFERON®-TB Gold test who are actively on anti-TB treatment can enroll if they have completed at least 1 month of anti-TB treatment and intend to complete the full course of anti-TB treatment. Subjects with an indeterminate QuantiFERON®-TB Gold test result can enroll if a repeat QuantiFERON®-TB Gold is negative or a tuberculin skin test is negative.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score at end of the RCP
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    - Change in Quantitative Myasthenia Gravis (QMG) scores at the end of the RCP.
    - Proportion of subjects with both (1) ≥ 3-point improvement in MG-ADL at end of RCP and (2) no use of rescue therapy.
    - Change in MG-ADL at Week 26 in the AChR-Ab+ population.

    Additional secondary endpoints:
    - Time to first exacerbation.
    - Change in Myasthenia Gravis Composite (MGC) score.
    - Change in Myasthenia Gravis Quality of Life-15, revised (MGQOL-15r) score .
    - Change in Patient Global Impression of Change (PGIC) score.
    - The safety and tolerability of inebilizumab as measured by the incidence of TEAEs, adverse events of special interest (AESIs), and TESAEs. Laboratory measurements will also be evaluated as part of safety.
    - PK profile of inebilizumab.
    - ADA status and titer.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    The second part of trial is optional and open label
    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 trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Argentina
    Australia
    Belarus
    Brazil
    Canada
    China
    Denmark
    Finland
    France
    Germany
    Guatemala
    India
    Israel
    Italy
    Japan
    Poland
    Russian Federation
    Spain
    Turkey
    Ukraine
    United States
    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 complete when the last active subject completes the Day 547 visit of the OLP, discontinues the OLP, or (for patients who have opted out of the OLP) completes the RCP.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 212
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 252
    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 Decision2020-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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