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    Summary
    EudraCT Number:2015-003596-30
    Sponsor's Protocol Code Number:MEDI4736-MDS-001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-29
    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 ConcernedGermany - PEI
    A.2EudraCT number2015-003596-30
    A.3Full title of the trial
    A Randomized Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects with Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (≥ 65 years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and efficacy of the combination of durvalumab with azacitidine to treat a cancer of the bone marrow, causing cancer cell proliferation and improper normal blood cell production.
    A.3.2Name or abbreviated title of the trial where available
    FUSION HR MDS/ELDERLY AML 001 STUDY
    A.4.1Sponsor's protocol code numberMEDI4736-MDS-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02775903
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1182-9884
    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 SponsorCelgene International II Sàrl
    B.1.3.4CountrySwitzerland
    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 supportCelgene International II Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1888260 1599
    B.5.5Fax number+1913266 0394
    B.5.6E-mailClinicalTrialDisclosure@celgene.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 nameDurvalumab
    D.3.2Product code MEDI4736
    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 INNDURVALUMAB
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.4EV Substance CodeSUB176342
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    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 typeHumanised monoclonal antibody
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Vidaza
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberMDS: EU/3/01/084; AML: EU/3/07/509
    D.3 Description of the IMP
    D.3.1Product nameAzacitidine
    D.3.4Pharmaceutical form Powder for suspension 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 INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Vidaza
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberMDS: EU/3/01/084; AML: EU/3/07/509
    D.3 Description of the IMP
    D.3.1Product nameAzacitidine
    D.3.4Pharmaceutical form Powder for suspension 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 INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML)
    E.1.1.1Medical condition in easily understood language
    MDS: disorders
    where bone marrow produces fewer/immature blood cells

    AML: cancer of the white blood cells (myeloid cells)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10028536
    E.1.2Term Myelodysplastic syndromes
    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
    Evaluate the efficacy of subcutaneous (sc) azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in the defined study population.
    E.2.2Secondary objectives of the trial
    Safety: Assess the safety and tolerability of subcutaneous (sc) azacitidine in combination with durvalumab compared with subcutaneous azacitidine alone in the defined study population.

    Pharmacokinetics: To assess the pharmacokinetics (PK) of durvalumab when given in combination with subcutaneous azacitidine in the defined study population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For both cohorts:
    1. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
    2. Have an ECOG performance status of 0, 1, or 2.
    3. Female subjects of childbearing potential may participate, providing they meet the following conditions:
    a. Have 2 negative pregnancy tests as verified by the Investigator prior to starting any IP therapy: serum pregnancy test at screening and negative serum or urine pregnancy test (Investigator’s discretion) within 72 hours prior to starting treatment with IP (Cycle 1, Day 1). They must agree to ongoing pregnancy testing during the course of the study (before beginning each subsequent cycle of treatment), and after the last dose of any IP. This applies even if the subject practices complete abstinence from heterosexual contact.
    b. Agree to practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to the use of a highly effective method of contraception from 28 days prior to starting durvalumab or azacitidine, and must agree to continue using such precautions while taking durvalumab or azacitidine (including dose interruptions) and for up to 90 days after the last dose of durvalumab or azacitidine. Cessation of contraception after this point should be discussed with a responsible physician.
    c. Agree to abstain from breastfeeding during study participation and for at least 90 days after the last dose of IP.
    d. Refrain from egg cell donation while taking durvalumab and for at least 90 days after the last dose of durvalumab.
    4. Male subject must:
    a. Either practice true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to avoid fathering a child, to use highly effectice methods of contraception, male condom plus spermicide during sexual contact with a pregnant female or a female of childbearing potential (even if he has undergone a successful vasectomy) from starting dose of IP (Cycle 1 Day 1), including dose interruptions through 90 days after receipt of the last dose of durvalumab or azacitidine.
    b. Refrain from semen or sperm donation while taking IP and for at least 90 days after the last dose of IP.
    5. Understand and voluntarily sign a biomarker-specific component of the informed consent form prior to any study-related procedures conducted.
    6. Willing and able to adhere to the study visit schedule and other protocol requirements.

    MDS Cohort:
    7. Age ≥ 18 years at the time of signing the informed consent form.
    8. Central confirmation of diagnosis of previously untreated primary or secondary MDS as per WHO classification. Results of central pathology review are required prior to receiving the first dose of IP.
    9. Central confirmation of the categorization of the MDS risk classification, as per the IPSS-R Intermediate risk with >10% blasts or poor or very poor cytogenetics, or IPSS-R High or Very High risk (Results of central pathology review required prior to receiving the first dose of IP).

    AML Cohort:
    10. Age ≥ 65 years at the time of signing the informed consent form (ICF).
    11. Central confirmation of diagnosis of one of the following untreated AML as per WHO classification:
    · Newly diagnosed, histologically confirmed de novo AML (bone marrow blasts ≥ 20%), or
    · AML secondary to prior MDS, or
    · AML secondary to exposure to potentially leukemogenic therapies or agents (eg, radiation therapy, alkylating agents, topoisomerase II inhibitors) with the primary malignancy in remission for at least 2 years.
    12. Central confirmation of intermediate or poor risk status, based on Cytogenetics for Acute Myeloid Leukemia.

    For Optional Extension Phase:
    At the Investigator's discretion, subjects meeting all the following continuation criteria are eligible to enter the optional extension phase:
    1. Subjects who have signed the addendum informed consent for the extension phase of the study.
    2. Subjects who do not meet any of the following treatment discontinuation criteria:
    • Adverse Event
    • Progressive disease
    • Withdrawal by subject
    • Lost to follow-up
    • Pregnancy
    3. Subjects who continue to show clinical benefit from study treatment as per the Investigator's assessment.

    Subjects will start the extension phase at the time of the next regularly scheduled dosing cycle for study drug azacitidine or azacitidine and
    durvalumab.
    E.4Principal exclusion criteria
    For both cohorts:
    1. Prior hematopoietic stem cell transplant.
    2. Considered eligible for hematopoietic stem cell transplant (allogeneic or autologous).
    3. Prior exposure to azacitidine, decitabine or prior exposure to the investigational oral formulation of decitabine, or other oral azacitidine derivative.
    4. Inaspirable bone marrow.
    5. Use of any of the following within 28 days prior to the first dose of IP:
    · Thrombopoiesis-stimulating agents
    · Any hematopoietic growth factors
    · Any investigational agents within 28 days or 5 half-lives (whichever is longer) of initiating study treatment
    6. Prior history of malignancies, (except MDS for AML subjects), unless the subject has been free of the disease for ≥ 2 years. However, subjects with the following history/concurrent conditions are allowed:
    · Basal or squamous cell carcinoma of the skin
    · Carcinoma in situ of the cervix
    · Carcinoma in situ of the breast
    · Incidental histologic finding of prostate cancer.
    7. Pregnant or breast-feeding females or females who intend to become pregnant during study participation.
    8. Subject has active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
    · Subjects with vitiligo or alopecia;
    · Subjects with hypothyroidism stable on hormone replacement for ≥ 3 months prior to signing the ICF; or
    · Subjects with psoriasis not requiring systemic treatment
    9. Significant active cardiac disease within the previous 6 months prior to signing the ICF
    10. Uncontrolled intercurrent illness.
    11. Known HIV or HCV infection, or evidence of active HBV infection.
    12.Known or suspected hypersensitivity to azacitidine, mannitol, or durvalumab, its constituents, or to any other humanized mAb.
    13. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
    14. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
    15. Prior anti-CTLA-4, PD-1, or PD-L1 or other immune checkpoint mAb exposure.
    16. Other investigational mAbs within 6 months prior to first dose of IP.
    17. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions:
    · Intranasal, inhaled, topical, or local steroid injections
    · Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
    · Steroids as premedication for hypersensitivity reactions
    18. History of primary immunodeficiency.
    19. Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP.
    20. Unwilling or unable to complete subject reported outcome assessments without assistance or with minimal assistance from trained site personnel and/or caregiver.
    21. Subjects who have had clinical evidence of CNS or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia.
    22. Presence of advanced malignant hepatic tumors.
    23. Any of the following laboratory abnormalities:
    · AST/SGOT or ALT/SGPT > 2.5 × ULN
    · Serum total bilirubin > 1.5 × ULN. Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow. Subjects are excluded if there is evidence of autoimmune hemolytic anemia manifested as a corrected reticulocyte count of > 2% with either a positive Coombs’ test or over 50% of indirect bilirubin
    · Serum creatinine > 2.5 × ULN.

    MDS Cohort:
    24. Any previous cytotoxic, cytostatic, hormonal, biological or immunological treatment for MDS.
    25. Any investigational therapy within 28 days prior to the first dose of IP.
    26. Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
    27. Absolute WBC count ≥ 15 × 109/L.

    AML Cohort:
    28. Previous cytotoxic, cytostatic, hormonal, biological or immunological treatment or biologic treatment for AML.
    29. Any investigational therapy within 28 days prior to the first dose of IP.
    30. Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
    31. Prior use of targeted therapy agents.
    32. Suspected or proven acute promyelocytic leukemia (FAB M3) based on morphology, immunophenotype, molecular assay, or karyotype; AML associated with t(9;22) karyotype, biphenotypic acute leukemia or AML with previous hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms.
    33. Acute myeloid leukemia associated with inv(16), t(8;21), t(16;16), t(15;17) karyotypes or molecular evidence of such translocations if not associated with a c-kit mutation.
    34. Absolute WBC count ≥ 15 × 109/L.
    35. Known history or presence of Sweet Syndrome at screening.
    E.5 End points
    E.5.1Primary end point(s)
    MDS Cohort:
    - Overall response rate (defined as CR, PR, mCR and/or HI) using the IWG 2006 response criteria for MDS

    AML Cohort:
    - Overall response rate (CR or CRi) based on modified IWG 2003 response criteria for AML
    E.5.1.1Timepoint(s) of evaluation of this end point
    IWG Response Assessment based on IWG criteria for MDS and modified IWG criteria for AML is to be performed every 3 cycles of treatment during the first 6 treatment cycles. Subjects who continue beyond Cycle 6 will have IWG response assessment following every 3 treatment cycles. The assessment must be performed prior to beginning Day 1 procedures for the subsequent treatment cycle (Cycle 4, 7, 10, etc).
    E.5.2Secondary end point(s)
    MDS Cohort:
    1- Time to response
    2- Relapse-free survival
    3- Cytogenetic response
    4- Progression-free survival (PFS)
    5- Duration of response
    6- Time to AML transformation
    7- Transformation to AML

    AML Cohort:
    1- Time to response
    2- Relapse-free survival
    3- Complete cytogenetic response (CyCR)
    4- Hematologic Improvement Rate
    5- Duration of response

    Phase 2: Both Cohorts:
    1- Safety
    2- Overall survival
    3- One-year survival
    4- PK parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    MDS
    1-C1D1 to CR,PR or mCR
    2-CR,PR or mCR until relapse,death or loss to FU
    3-C1D1 to documentation of CyCR or partial cytogenetic response
    4-C1D1 to progression or death
    5-CR,PR or mCR until relapse or PD
    6-C1D1 until date of transformation to AML
    7-Ongoing
    AML
    1-C1D1 to response
    2-CR or CRi until relapse,death or loss to FU
    3-C1D1 until CyCR
    4-C1D1 to rate of Neutrophil response+Eythroid response+Platelet response
    5-Time from first CR/CRi until relapse, PD or death
    Both
    1-Ongoing incl FU
    2-C1D1 to death
    3-Prob of survival at 1 year from randomisation
    4-C1D1 end of infusion;C2D1 preinfusion(-90m to -5m prior to dose);C4D1 preinfusion(-90m to -5m prior to dose) and end of infusion;C6D1 preinfusion(-90m to -5m prior to dose);Safety FU (90d after last dose of MEDI4736)
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity analysis, Biomarker analysis
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Austria
    Belgium
    Canada
    France
    Germany
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    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 End of Trial is either the date of LSLV for completion of posttreatment follow-up, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as prespecified in the protocol, whichever is later.

    The extension phase will be considered complete when the last patient included in this phase completes their last treatment cycle and has been followed-up as per the site standard of care.
    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 months3
    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 months3
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 152
    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 170
    F.4.2.2In the whole clinical trial 182
    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 Decision2016-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-27
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