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    Summary
    EudraCT Number:2019-004103-12
    Sponsor's Protocol Code Number:TAK-079-1004
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-22
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2019-004103-12
    A.3Full title of the trial
    A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune Thrombocytopenia
    A.4.1Sponsor's protocol code numberTAK-079-1004
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1245-3760
    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 SponsorTakeda Development Center Americas, Inc. (Takeda)
    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 supportTakeda Development Center Americas, Inc. (Takeda)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Center Americas, Inc. (Takeda)
    B.5.2Functional name of contact pointDrug Information Call Center
    B.5.3 Address:
    B.5.3.1Street Address95 Hayden Avenue
    B.5.3.2Town/ cityLexington, MA
    B.5.3.3Post code02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number0015107402412
    B.5.5Fax number0018008816092
    B.5.6E-mailmedical@mlnm.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 nameTAK-079
    D.3.2Product code TAK-079
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMezagitamab
    D.3.9.2Current sponsor codeTAK-079
    D.3.9.3Other descriptive nameTAK-079
    D.3.9.4EV Substance CodeSUB178418
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary immune thrombocytopenia
    E.1.1.1Medical condition in easily understood language
    Low levels of the blood cells that prevent bleeding (platelets)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10050245
    E.1.2Term Autoimmune thrombocytopenia
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the safety and tolerability of TAK-079 in patients with persistent/chronic primary ITP.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the effects of TAK-079 administration on platelet counts in patients with persistent/chronic primary ITP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet all the following inclusion criteria to be to be randomized to treatment:
    1. Age 18 years or older and able and willing to comply with study procedures.
    2. Diagnosed with ITP that has persisted for ≥3 months, diagnosed in accordance to The American Society of Hematology 2011 Evidence-based Practice Guideline for Immune Thrombocytopenia or the International Consensus Report on The Investigation and Management of Primary Immune Thrombocytopenia as locally applicable.
    3. Has a mean platelet count of <30,000/µL (and individually = 35,000/µL) on at least 2 measurements at least 1 week apart during
    screening
    4.Diagnosis of ITP supported by a prior response to an ITP therapy (other than a TPO-RA)
    that achieved a platelet count of =50,000/µL.
    5. If receiving standard background treatment for ITP, treatment should be stable in dose and frequency for at least 4 weeks before dosing.
    a) Permitted standard background treatments may include: 1 oral corticosteroid; ±1 immunosuppressant from the following list: azathioprine, danazol, dapsone, cyclosporine, mycophenolate mofetil, mycophenolate sodium; ±1 TPO-RA (romiplostim, eltrombopag, avatrombopag); ±fostamatinib. Corticosteroids, including dexamethasone, must be given as oral, daily or every other day therapy as opposed to pulse therapy. High-dose pulse steroid therapy is not
    allowed within 14 days before Day 1.
    b) The dose of any permitted standard background therapy must be expected to remain stable through the study, unless dose reduction is required because of toxicities.
    6. Female patients of childbearing potential are required to have a negative pregnancy test. Both female patients of childbearing potential and male patients must practice an effective, reliable,
    and approved contraceptive regimen during the study and for up to 90 days or 5 half-lives, whichever is longer, after discontinuation of treatment.
    7. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
    E.4Principal exclusion criteria
    Patients meeting any of the following exclusion criteria are not to be randomized to treatment:
    1. Use of anticoagulants or any drug with antiplatelet effect (such as aspirin) within 3 weeks before screening.
    2. History of any thrombotic or embolic event within 12 months before screening.
    3. History of splenectomy within 3 months before screening.
    4. Use of intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin or anti-D immunoglobulin treatment within 4 weeks of screening, or an expectation that any therapy besides the patient's standard background therapies may be used for treatment of thrombocytopenia (eg, a rescue therapy) between
    screening and dosing.
    5. Diagnosed with chronic obstructive pulmonary disease (COPD) or asthma, and a prebronchodilatory forced expiratory volume in 1 second (FEV1) <50% of predicted normal.
    Note: FEV1 testing is required for patients suspected of having COPD or asthma.
    6. Use of rituximab or any mAb for immunomodulation within 4 months before first dosing.
    Note: Patients with prior exposure to rituximab must have CD19 counts within the normal range at screening.
    7. Use of immunosuppressants (such as cyclophosphamide, vincristine) other than permitted oral immunosuppressants within 6 months before first dosing.
    8. Diagnosed with myelodysplastic syndrome.
    9. Has received a live vaccine within 4 weeks before screening or has any live vaccines planned during the study.
    10. Currently experiencing any medical condition that, in the opinion of the investigator, might interfere with the patient’s participation in the study (such as significant ocular, cardiovascular, pulmonary, hematologic, gastrointestinal, endocrinologic, hepatic, renal, neurologic, malignancy, or infectious disease), that poses an added risk for the patient, or could confound the assessment of the patient.
    11. Pregnancy or lactation during screening period or on Day 1 before first dose of study drug.
    12. Participation in any other investigational drug study (including vaccine study) or exposure to other investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Day 1.
    13. Has had an opportunistic infection ≤12 weeks before initial study dosing or is currently undergoing treatment for a chronic opportunistic infection, such as tuberculosis (TB), pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria. A mild, localized herpes simplex infection within 12 weeks before study treatment is initiated is allowed, as long as the lesion has resolved without systemic therapy before Day 1.
    14. Exhibits clinically significant laboratory abnormalities at screening:
    a) Alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of normal (ULN).
    b) Total bilirubin >1.5 × ULN (Note: Patients with a confirmed diagnosis of Gilbert syndrome that is documented in the patient’s medical record are not excluded based on this criterion).
    c) Absolute neutrophil count <1500/mm3.
    d) Hemoglobin <8 g/dL.
    e) Immunoglobulin (Ig) G <500 mg/dL.
    f) Lymphocyte count <500/mm3.
    g) Creatinine clearance, CrCl, <30 mL/min (ie, CrCl ≥30 mL/min is allowed).
    15. Has a positive T-cell interferon-γ release assay (TIGRA) (results through QuantiFERON TB Gold test or T-Spot/Elispot) at the screening visit, noting the following:
    a) A purified protein derivative (PPD) skin test may be used as a replacement, if TIGRA testing is not available.
    b) Patients with an indeterminate TIGRA result must meet the following criteria:
    – Has a negative PPD skin test (defined as <5 mm induration).
    – Is at low risk of acquiring TB (eg, avoids close contact with TB positive individual[s]), and/or chest x-ray ≤6 months before the screening visit that is consistent with no evidence of latent or active TB).
    16. Has a serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
    17. Has hepatitis B (a positive test result for hepatitis B surface antigen [HBsAg], or hepatitis B core antibody [anti-Hbc]), or Hepatitis C (positive HCV RNA), or HIV antibody/antigen, at screening. However, an individual who has a known history of chronic hepatitis C and has been treated and fully cured of the disease, confirmed with a negative hepatitis C virus RNA polymerase chain reaction test at screening, is not excluded on the basis of positive hepatitis C antibody alone.
    18. Has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the TAK-079/placebo formulation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percentage of patients with TEAEs including Grade 3 or higher events, SAEs, and AEs leading to TAK-079 discontinuation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    TEAEs that occur after administration of the first dose of TAK-079 and through to the end of the SFP period will be tabulated and followed until resolution.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints assess the effects of TAK-079 administration on the changes in the platelet count, through the following 4 endpoints:
    1. The percentage of patients with a platelet response. Platelet response is defined as a platelet count ≥50,000/μL and ≥20,000/μL above baseline on at least 2 visits without a dosing period–permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy.
    2. The percentage of patients with a complete platelet response. Complete platelet response is defined as a platelet count ≥100,000/μL on at least 2 visits without a dosing period–permitted rescue treatment in the previous 4 weeks and without any other previous rescue therapy.
    3. The percentage of patients with a clinically meaningful platelet response. A clinically meaningful platelet response is defined as a platelet count ≥20,000/μL above baseline on at least 2 visits without a dosing period–permitted rescue treatment in the previous 4 weeks and without any other previous concomitant rescue therapy.
    4. The percentage of patients with a hemostatic platelet response. A hemostatic platelet response is defined for patients with a baseline platelet count of <15,000/μL who achieve a platelet count of ≥30,000/μL and ≥20,000/μL above baseline on at least 2 visits without a dosing period–permitted rescue treatment in the previous 4 weeks and without any other previousr escue therapy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study. Please refer to protocol Appendix A and Appendix B.
    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 No
    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) 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 trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    China
    Japan
    United States
    Ukraine
    Bulgaria
    Croatia
    Germany
    Greece
    Italy
    Slovenia
    Spain
    E.8.7Trial has a data monitoring committee No
    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 analyses for the clinical study report will be conducted after all patients randomized in the study have completed the end-of-study visit (ie, Week 32 for TAK-079 patients, Week 20 for placebo patients who chose not to enter the OLE, or EW32 for placebo patients who participated in the OLE)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 54
    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 Decision2020-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-06
    P. End of Trial
    P.End of Trial StatusOngoing
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