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    Summary
    EudraCT Number:2015-001318-92
    Sponsor's Protocol Code Number:AP24534-15-303
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-12-28
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2015-001318-92
    A.3Full title of the trial
    A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib
    A.3.2Name or abbreviated title of the trial where available
    OPTIC 2L
    A.4.1Sponsor's protocol code numberAP24534-15-303
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02627677
    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 SponsorARIAD Pharmaceuticals, 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 supportARIAD Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationARIAD Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointSara Green
    B.5.3 Address:
    B.5.3.1Street Address26 Landsdowne Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number1617503 7019
    B.5.5Fax number1617225 2688
    B.5.6E-mailsara.green@ariad.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/716 - treatment of CML
    D.3 Description of the IMP
    D.3.1Product nameponatinib
    D.3.2Product code AP24534
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPonatinib
    D.3.9.1CAS number 943319-70-8
    D.3.9.2Current sponsor codeAP24534
    D.3.9.3Other descriptive namePonatinib hydrochloride
    D.3.9.4EV Substance CodeSUB91901
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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: 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 Iclusig
    D.2.1.1.2Name of the Marketing Authorisation holderARIAD Pharma Ltd.
    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 numberEU/3/09/716 - treatment of CML
    D.3 Description of the IMP
    D.3.1Product nameponatinib
    D.3.2Product code AP24534
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPonatinib
    D.3.9.1CAS number 943319-70-8
    D.3.9.2Current sponsor codeAP24534
    D.3.9.3Other descriptive namePonatinib hydrochloride
    D.3.9.4EV Substance CodeSUB91901
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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 Iclusig
    D.2.1.1.2Name of the Marketing Authorisation holderARIAD Pharma Ltd.
    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 numberEU/3/09/716 - treatment of CML
    D.3 Description of the IMP
    D.3.1Product nameponatinib
    D.3.2Product code AP24534
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPonatinib
    D.3.9.1CAS number 943319-70-8
    D.3.9.2Current sponsor codeAP24534
    D.3.9.3Other descriptive namePonatinib hydrochloride
    D.3.9.4EV Substance CodeSUB91901
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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: 4
    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 Tasigna
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 numberEU/3/06/375
    D.3 Description of the IMP
    D.3.1Product namenilotinib
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNILOTINIB
    D.3.9.1CAS number 641571-10-0
    D.3.9.4EV Substance CodeSUB25225
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Chronic Phase Chronic Myeloid Leukemia
    E.1.1.1Medical condition in easily understood language
    Chronic Phase Chronic Myeloid Leukemia
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10054352
    E.1.2Term Chronic phase chronic myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of ponatinib administered at 2 starting
    doses (30 and 15 mg once daily [QD]) compared to nilotinib administered at 400 mg twice daily (BID) in patients with CP-CML who are resistant to imatinib, as measured by major molecular response (MMR) by 12 months.
    E.2.2Secondary objectives of the trial
     To characterize, according to each arm and ponatinib starting dose, the rate of VOEs, AEs, and serious adverse events (SAEs)
     To characterize, according to each arm and ponatinib starting dose, the rate of cytogenetic responses and molecular responses other than MMR
     To further characterize efficacy according to each arm and ponatinib starting dose, including time to response, duration of cytogenetic and molecular response, duration of therapy, progression free survival, overall survival, and impact of dose escalation after loss of response (ponatinib cohorts only)
     To characterize, according to each arm and ponatinib starting dose, the rate of discontinuation, dose reductions, and interruptions
     To characterize, according to each arm and ponatinib starting dose, the rate of hematologic responses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have CP-CML and are resistant to first-line imatinib treatment.
    a. The diagnosis of CML will be made using standard hematopathologic and cytogenetic criteria. CP-CML will be defined by all of the following:
    i <15% blasts in bone marrow
    ii <30% blasts plus promyelocytes in bone marrow
    iii <20% basophils in peripheral blood
    iv ≥100 × 109/L platelets (≥100,000/mm3)
    v No evidence of extramedullary disease except hepatosplenomegaly
    vi No prior diagnosis of AP- or BP-CML
    b. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22) Philadelphia chromosome.
    i Conventional chromosome banding must be performed
    ii A minimum of 20 metaphases must be assessable at entry
    iii Variant translocations are not allowed
    c. BCR-ABL transcript levels must be assessable using the International
    Scale.
    i b2a2 or b3a2 transcript type
    d. Resistance is defined as follows. Patients must meet at least 1 criterion.
    i Three months after the initiation of therapy: No cytogenetic response (>95% Ph+) or failure to achieve CHR.
    ii Six months after the initiation of therapy: BCR-ABLIS >10% and/or >35% Ph+.
    iii Twelve months after the initiation of therapy: BCR-ABLIS >1% and/or Ph+ >0.
    iv At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of MCyR.
    v At any time after the initiation of therapy, the development of new clonal evolution in the absence of MCyR.
    vi At any time after the initiation of therapy, the loss of CHR, the loss of CCyR, or the confirmed loss of MMR (in 2 consecutive tests, one of which has a BCR-ABLIS transcript level of ≥1%.
    [NOTE: The above criteria were adapted from Baccarani et al, 2013.]
    2. Be male or female ≥18 years old.
    3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    4. Have adequate renal function as defined by the following criterion:
    a. Serum creatinine ≤1.5 × upper limit of normal (ULN) for institution.
    5. Have adequate hepatic function as defined by all of the following criteria:
    a. Total serum bilirubin ≤1.5 × ULN, unless due to Gilbert’s syndrome.
    b. Alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 × ULN if leukemic infiltration of the liver is present.
    c. Aspartate aminotransferase (AST) ≤2.5 × ULN or ≤5 × ULN if leukemic infiltration of the liver is present.
    6. Have normal pancreatic status as defined by the following criterion:
    a. Serum lipase and amylase ≤1.5 × ULN.
    7. Have a negative pregnancy test documented prior to enrollment (for females of childbearing potential).
    8. Agree to use a highly effective form of contraception with sexual partners from the time of randomization through at least four (4) months after end of study treatment (for female and male patients who are fertile).
    9. Provide written informed consent.
    10. Be willing and able to comply with scheduled visits and study procedures.
    11. Have fully recovered (≤ grade 1 or returned to baseline or deemed irreversible) from the acute effects of prior cancer therapy (ie, hydroxyurea or imatinib) before initiation of study drug.
    E.4Principal exclusion criteria
    1. Have previously been treated with any approved or investigational TKIs other than imatinib or treated with imatinib within 14 days prior to receiving study drug.
    2. Have previously been treated with any anti-CML therapy other than hydroxyurea, including interferon, cytarabine, immunotherapy, or any cytotoxic chemotherapy, radiotherapy, or investigational therapy.
    3. Underwent autologous or allogeneic stem cell transplant.
    4. Are in CCyR or MMR.
    5. Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
    a. Any history of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (TIA)
    b. Any history of peripheral vascular infarction, including visceral infarction
    c. Any history of a revascularization procedure, including vascular surgery or the placement of a stent
    d. History of venous thromboembolism, including deep venous thrombosis, superficial venous thrombosis, or pulmonary embolism, within 6 months prior to enrollment
    e. Congestive heart failure (New York Heart Association [NYHA] class III or IV) within 6 months prior to enrollment or left ventricular ejection fraction (LVEF) less than 45% or less than the institutional lower limit of normal (whichever is higher) within 6 months prior to enrollment
    6. Have cardiac conduction abnormalities as follows:
    a. QTcF >450 msec on the average of 3 serial baseline ECGs (using the QTcF formula); congenital long QT syndrome, or a known family history of long QT syndrome; or inability to determine the QTcF
    b. Presence of a complete left bundle branch block
    c. Use of a ventricular pacemaker
    d. History of clinically significant (as determined by the treating physician) atrial arrhythmia
    e. Resting bradycardia <50 beats per minute
    f. Any history of ventricular arrhythmia
    7. Are taking medications with a known risk of Torsades de Pointes or that have the potential to prolong the QT interval (Appendix A), unless the medication can be discontinued or be substituted by another without the risk.
    8. Are taking medicines that are strong CYP3A4 inhibitors, unless the medication can be discontinued or be substituted by another that is not an inhibitor (Appendix B)
    9. Are taking medicines that are strong CYP3A4 inducers, unless the medication can be discontinued or be substituted by another that is not an inducer (Appendix B)
    10. Have uncontrolled hypertension (diastolic blood pressure >90 mmHg and/or systolic >150 mmHg). Patients with hypertension should be under treatment at study entry to effect blood pressure control.
    11. Have poorly controlled diabetes, defined as HbA1c values over the previous year of >7.5% (59 mmol/mL) on more than 3 occasions. Patients with preexisting, well-controlled, diabetes are not excluded.
    12. Have uncorrected hypokalemia or hypomagnesemia.
    13. Have active central nervous system (CNS) disease as evidenced by cytology or pathology. In the absence of clinical CNS disease, lumbar puncture is not required. A history of CNS involvement itself is not an exclusion if the CNS has been cleared of disease with a documented negative lumbar puncture.
    14. Have a significant bleeding disorder unrelated to CML.
    15. Have a history of thrombophilia (eg, Protein C deficiency)
    16. Have a history of alcohol abuse.
    17. Have a history of acute pancreatitis within 1 year of study entry or history of chronic pancreatitis.
    18. Have history of malabsorption syndrome or other gastrointestinal condition that could affect oral absorption of study drug.
    19. Have a history of a different malignancy, other than cervical cancer in situ or basal cell or squamous cell carcinoma of the skin, except if patient has been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy.
    20. Are pregnant or lactating.
    21. Have undergone major surgery within 14 days prior to first dose of study treatment. Minor surgical procedures, such as catheter placement or bone marrow biopsy are allowed.
    22. Have an ongoing or active infection. This includes but is not limited to the requirement for intravenous antibiotics.
    23. Have any surgical or medical condition / illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the study drug.
    24. Have hypersensitivity to the active substance in ponatinib and nilotinib or to any of the inactive ingredients listed in Section 14.9.1.1 for ponatinib and in Section 14.9.1.2 for nilotinib
    E.5 End points
    E.5.1Primary end point(s)
    Major molecular response (MMR) by 12 months for each cohort.
    E.5.1.1Timepoint(s) of evaluation of this end point
    By 12 months of treatment.
    E.5.2Secondary end point(s)
    1. Cytogenetic response rates:
    a. Major cytogenetic response (MCyR) by 12 months
    b. Complete cytogenetic response (CCyR) at12 months

    2. Molecular response rates: MR2, MR3/MMR, MR4, MR4.5 at 3-month intervals until end-of-treatment and MR1 (≤10% BCR-ABLIS) at 3 months

    3. Safety
    a. Vascular occlusive events in each cohort
    b. AEs in each cohort
    c. SAEs in each cohort

    4. Time to response

    5. Duration of response:
    a. MR2 and MMR at 3, 6, 9, and 12 months, and then at 3-month intervals until completion of treatment
    b. MCyR at 12 months, by cytogenetic analysis
    c. Duration of response in responders
    d. Duration of therapy

    6. Progression-free survival

    7. Overall survival

    8. Hematologic response: complete hematologic response (CHR)

    9. Tolerability:
    a. Discontinuations due to AEs in each cohort
    b. Dose reductions due to toxicity (prior to response) in each cohort
    c. Dose interruptions in each cohort

    10. Progression to accelerated phase (AP) or blast phase (BP) CML
    E.5.2.1Timepoint(s) of evaluation of this end point
    At each visit and the final analysis will be done at the end of the study.
    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 No
    E.6.7Pharmacodynamic No
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    Austria
    Belgium
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Hong Kong
    Hungary
    Israel
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Singapore
    Spain
    Switzerland
    Turkey
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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: 384
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 216
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with incurable diseases
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 369
    F.4.2.2In the whole clinical trial 600
    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 Decision2016-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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