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    Summary
    EudraCT Number:2020-000417-33
    Sponsor's Protocol Code Number:VIB0551.P3.S2
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-08-06
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-000417-33
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease
    3. fázisú, randomizált, kettős vak, multicentrikus, placebo-kontrollos vizsgálat az inebilizumab hatásosságának és biztonságosságának értékelésére IgG4-asszociált betegségben szenvedőknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Inebilizumab efficacy and safety in IgG4 related disease
    Inebilizumab hatásossága és biztonságossága IgG4-asszociált betegségben
    A.3.2Name or abbreviated title of the trial where available
    MITIGATE
    A.4.1Sponsor's protocol code numberVIB0551.P3.S2
    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 number001240-558-0038
    B.5.5Fax number001240-772-9578
    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 codeMEDI-551
    D.3.9.3Other descriptive nameafucosylated IgG1 kappa 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 humanized, affinity-optimized, afucosylated immunoglobulin G1 kappa (IgG1k) 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
    Immunoglobulin G4-related disease (IgG4-RD)
    E.1.1.1Medical condition in easily understood language
    IgG4-RD is a chronic, relapsing-remitting, immune-mediated fibroinflammatory disorder
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10077271
    E.1.2Term Immunoglobulin G4 related disease
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 evaluate the efficacy of inebilizumab in reducing the risk of a disease flare in patients with IgG4-RD
    E.2.2Secondary objectives of the trial
    .To evaluate the safety and tolerability of inebilizumab in patients with IgG4-RD.
    .To evaluate the effect of inebilizumab on other measures of disease activity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    .Male or female adults, ≥ 18 years of age at time of informed consent.
    .Written informed consent and any locally required authorization.
    .Clinical diagnosis of IgG4-RD.
    .Fulfillment of the 2019 ACR/EULAR classification criteria, as determined by the Eligibility Committee. Specifically, subjects must meet the classification criteria entry requirements (including involvement of one of the following organs: pancreas, bile ducts/biliary tree, orbits, lungs, kidneys, lacrimal glands, major salivary glands, retroperitoneum, aorta, pachymeninges, or thyroid gland [Riedel’s thyroiditis]), must not meet any of the classification criteria exclusions, and must achieve at least 20 classification criteria inclusion points.
    .Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of GC treatment at the time of informed consent. This criterion may be met in two ways: − On GC therapy for recent IgG4-RD flare, having received a maximum of 4 weeks of treatment prior to informed consent at a dose no higher than 60 mg/day prednisone or equivalent, and at 20 mg/day prednisone or equivalent on the day prior to randomization, or
    − Experiencing active disease not currently being treated at the time of informed consent, with planned initiation of treatment for flare with GC at a maximum dose of 60 mg/day prednisone (or equivalent) and with a plan to be treated at a dose of 20 mg/day of prednisone (or equivalent) on the day prior to randomization, for a total duration of GC treatment during screening of at least 3 weeks at the time of randomization. This GC therapy can either be newly initiated or be increased from a maintenance dose of ≤ 10 mg/day of prednisone or equivalent. Subjects unable to be tapered to 20 mg/day of prednisone or equivalent by Visit 2 may not be randomized.
    .IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD with documentation to confirm.
    .Willing and able to comply with the protocol, complete study assessments, and complete the study period.
    .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 and must agree to continue using such precautions for at least 6 months after the final dose of IP.
    Females of childbearing potential must have a negative serum pregnancy test at screening.
    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 and at least 180 days after the last dose of IP; 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 will be made that the female partners (of childbearing potential) of male study participants should use a highly effective method of contraception other than a barrier method.
    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).
    E.4Principal exclusion criteria
    .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.
    .History of solid organ or cell-based transplantation.
    .Known immunodeficiency disorder.
    .Active malignancy or history of malignancy that was active within the last 10 years.
    .Receipt of any biologic B cell-depleting therapy in the 6 months prior to screening. Receipt of such a B cell-depleting agent in the period 6-12 months prior to screening is exclusionary unless B cell counts have returned to ≥ LLN by central laboratory.
    .Receipt of non-depleting B-cell-directed therapy, abatacept, or other biologic immunomodulatory agent within 6 months prior screening.
    .Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within 4 weeks prior to screening.
    .Receipt of any investigational agent < 12 weeks or < 5 half-lives of the drug prior to screening.
    .Inability to be tapered off of GC therapy by 8 weeks post-randomization, in the opinion of the Investigator.
    .Receipt of live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening.
    .Pregnancy, lactation, or planning to become pregnant within 6 months of the last dose of IP.
    .Positive test for, or prior treatment for, hepatitis B 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).
    .History of untreated hepatitis C infection, or positive antibody test for hepatitis C virus (HCV) unless patient is considered to be cured following antiviral therapy and has a HCV load below the limit of detection at least 24 weeks after completion of treatment.
    .Evidence of active tuberculosis (TB) or being at high risk for TB based on: − History of active TB or untreated/incompletely treated latent TB. Patients with a history of active or latent TB who have documentation of completion of treatment according to local guidelines may be enrolled.
    .History of > 1 episode of herpes zoster and/or any other definite or probable opportunistic infection in the 12 months prior to screening.
    .Known history of allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis to any human gamma globulin therapy.
    .Allergy to or intolerance of protocol-required treatment, including medications for prophylaxis of infusion reactions.
    .Estimated glomerular filtration rate < 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease Study (MDRD) equation (NIDDK).
    .Blood tests at screening that meet any of the following criteria: − Hemoglobin < 7.5 g/dL
    − Neutrophils < 1200/mm3
    − Platelets < 110 × 109/L
    − Eosinophil count > 3000/mm3
    − Prothrombin time above upper limit of normal (ULN)
    .Subjects with the following abnormal liver function tests in the absence of hepatobiliary IgG4-RD activity: − Aspartate aminotransferase (AST) > 2 × ULN
    − Alanine aminotransferase (ALT) > 2 × ULN
    − Total bilirubin (TBL) > 2 × ULN unless AST, ALT, and hemoglobin are within central laboratory normal range and the patient has a known history of Gilbert syndrome
    OR
    Subjects with the following abnormal liver function tests in the presence of hepatobiliary IgG4-RD activity:
    − AST > 10 × ULN
    − ALT > 10 × ULN
    − TBL > 5 × ULN
    Screening liver function tests may be repeated prior to randomization to permit abnormal values due to hepatobiliary IgG4-RD activity to respond to GC treatment.
    .Anti-neutrophil cytoplasmic antibodies (ANCA) targeted against proteinase 3 or myeloperoxidase at the central laboratory.
    .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.
    .Active, clinically significant infection at the time of randomization (IP administration may be delayed until recovery, if within screening window, otherwise subject may be rescreened).
    .Participation in any clinical trial that includes use of any pharmacologic intervention.
    E.5 End points
    E.5.1Primary end point(s)
    Time to disease flare, defined as the time in days from Day 1 (dosing) to the date of the first treated and AC-determined IgG4 RD flare within the 52-week RCP. The date of disease flare is defined as the date of initiation of any flare treatment (new or increased GC treatment, other immunotherapy, or interventional procedure) deemed necessary by the Investigator for the flare.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52-week RCP
    E.5.2Secondary end point(s)
    .Incidence of TEAEs, TESAEs, and treatment-emergent adverse events of special interest (AESIs) during the 52-week RCP and during the OLP.
    .The incidence of ADAs directed against inebilizumab during the RCP.
    .Annualized flare rate for treated and AC-determined flares during the RCP.
    .Annualized flare rate for AC-determined flares, whether or not treated, during the RCP.
    .The proportion of subjects achieving flare-free complete remission at Week 52. Complete remission is defined as an IgG4-RD Responder Index (RI, Wallace et al, 2018) score of 0 at Week 52, no AC-determined flare during the RCP, and no treatment for flare or disease control except the required 8-week GC taper.
    .Time to initiation of first treatment (medication or procedure) for new or worsening disease activity by the Investigator within the RCP, regardless of AC determination of flare.
    .Glucocorticoid use, calculated as the cumulative GC dose taken for the purpose of IgG4-RD disease control during the RCP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52-week RCP
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Australia
    Canada
    China
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Spain
    Ukraine
    United Kingdom
    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 365 visit of the OLP or discontinues the OLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 160
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 200
    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 Opinion2020-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
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