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    Summary
    EudraCT Number:2018-004889-34
    Sponsor's Protocol Code Number:NN7415-4311
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2021-06-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-004889-34
    A.3Full title of the trial
    Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B with inhibitors
    Efficacia e sicurezza del trattamento in profilassi con concizumab in pazienti affetti da emofilia A o B con inibitori
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study to look at how well the drug concizumab works in your body if you have haemophilia with inhibitors
    Uno studio di ricerca per valutare come funziona nel corpo il farmaco concizumab in pazienti con emofilia A o B con inibitori
    A.3.2Name or abbreviated title of the trial where available
    explorer7
    Explorer 7
    A.4.1Sponsor's protocol code numberNN7415-4311
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1225-9670
    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 SponsorNOVO NORDISK. S.P.A.
    B.1.3.4CountryItaly
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointClinical Disclosure (1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo Allé
    B.5.3.2Town/ cityBagsværd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.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 numberEMA/OD/095/12, EMA/OD/116/17
    D.3 Description of the IMP
    D.3.1Product nameConcizumab C 100 mg/mL PDS290
    D.3.2Product code [NN7415]
    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 INNConcizumab
    D.3.9.2Current sponsor codeConcizumab
    D.3.9.3Other descriptive nameConcizumab
    D.3.9.4EV Substance CodeSUB192373
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.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 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 numberEMA/OD/095/12, EMA/OD/116/17
    D.3 Description of the IMP
    D.3.1Product nameConcizumab C 40 mg/mL PDS290
    D.3.2Product code [NN7415]
    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 INNConcizumab
    D.3.9.2Current sponsor codeNo applicabile
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeSUB192373
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Haemophilia A with inhibitors
    Haemophilia B with inhibitors
    Emofilia A con inibitori
    Emofilia B con inibitori
    E.1.1.1Medical condition in easily understood language
    Bleeding disorders:
    - inherited deficiency in clotting factor VIII with antibodies to replacement therapy
    - inherited deficiency in clotting factor IX with antibodies to replacement therapy
    Disturbi emorragici ereditari:
    - fattore VIII della coagulazione con anticorpi verso la terapia sostitutiva
    - fattore IX della coagulazione con anticorpi verso la terapia sostitutiva
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10053751
    E.1.2Term Hemophilia A with anti factor VIII
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10053752
    E.1.2Term Hemophilia B with anti factor IX
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare effect of concizumab prophylaxis to no prophylaxis (on-demand treatment with bypassing agents) in reducing the number of bleeding episodes in adult and adolescent patients with haemophilia A or B with inhibitors
    Confrontare l'effetto del regime terapeutico in profilassi con concizumab rispetto al trattamento al bisogno (con agenti bypassanti) sulla riduzione del numero di episodi emorragici in pazienti adulti e adolescenti affetti da emofilia A o B con inibitori.
    E.2.2Secondary objectives of the trial
    1. To compare the patient reported outcomes (PROs) after treatment with concizumab prophylaxis vs no prophylaxis in adult and adolescent patients with haemophilia A or B with inhibitors
    2. To investigate the safety of concizumab prophylaxis in adult and adolescent patients with haemophilia A or B with inhibitors
    3. To investigate the PK and PD parameters of concizumab prophylaxis in adult and adolescent patients with haemophilia A or B with inhibitors
    1. Confrontare l’esito relativo ai questionari compilati dai pazienti (Patient Reported Outcomes, PRO) in seguito al trattamento con concizumab in regime di profilassi o in caso di trattamento al bisogno in pazienti adulti e adolescenti affetti da emofilia A o B con inibitori
    2. Valutare la sicurezza del trattamento in regime di profilassi con concizumab in pazienti adulti e adolescenti affetti da emofilia A o B con inibitori
    3. Valutare i parametri di PK e PD (farmacocinetica e farmacodinamica) in pazienti adulti e adolescenti affetti da emofilia A o B con inibitori in regime terapeutico di profilassi con concizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
    - Male aged 12 or older years at the time of signing informed consent
    - Congenital Haemophilia A or B of any severity with documented history of inhibitor (0.6 BU or more)
    - Patient has been prescribed, or in need of, treatment with bypassing agents in the last 24 weeks prior to screening (for patients not previously enrolled in NN7415-4310 Explorer 4)
    - Modulo di consenso informato ottenuto prima di qualsiasi attività correlata alla sperimentazione. Per attività correlate alla sperimentazione si intende qualunque procedura svolta nell’ambito della sperimentazione, incluse le attività richieste per determinarne l’idoneità alla partecipazione nello studio.
    - Soggetti di sesso maschile, di età pari o superiore a 12 anni di età al momento della firma del modulo di consenso informato.
    - Soggetti affetti da emofilia congenita A o B di qualsiasi severità con storia medica documentata di inibitori (uguale o superiore a 0,6 UB [Unità Bethesda]).
    - Soggetti ai quali è stato prescritto o che abbiano avuto necessità di un trattamento con agenti bypassanti nelle 24 settimane precedenti lo screening (per pazienti non precedentemente arruolati nello studio clinico NN7415-4310 Explorer 4).
    E.4Principal exclusion criteria
    - Known or suspected hypersensitivity to any constituent of the trial product or related products
    - Known inherited or acquired coagulation disorder other than congenital haemophilia
    - Ongoing or planned Immune Tolerance Induction treatment
    - History of thromboembolic disease (includes arterial and venous thrombosis including myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events and peripheral artery occlusion). Current clinical signs of, or treatment for thromboembolic disease. Patients who in the judgement of the investigator are considered at high risk of thromboembolic events (thromboembolic risk factors could include, but are not limited to, hypercholesterolemia, diabetes mellitus, hypertension, obesity, smoking, family history of thromboembolic events, arteriosclerosis, other conditions associated with increased risk of thromboembolic events).
    - Ipersensibilità nota o sospetta a qualsiasi componente del prodotto sperimentale o dei prodotti correlati
    - Patologie della coagulazione note ed ereditarie o acquisite diverse dall’emofilia congenita
    - Terapia di induzione della tolleranza immunologica (ITI) in corso o programmata
    - Storia clinica di malattia tromboembolica (compresa la trombosi arteriosa e venosa incluso l'infarto del miocardio, embolia polmonare, infarto/trombosi cerebrale, trombosi venosa profonda, altri eventi tromboembolici clinicamente significativi e occlusione dell'arteria periferica). Segni clinici attuali o trattamento della malattia tromboembolica. Pazienti che, a giudizio dello sperimentatore, sono considerati ad alto rischio di eventi tromboembolici (i fattori di rischio tromboembolici potrebbero includere, a titolo esemplificativo, ipercolesterolemia, diabete mellito, ipertensione, obesità, fumo, storia familiare di eventi tromboembolici, arteriosclerosi, altre condizioni associato ad un aumentato del rischio di eventi tromboembolici).
    E.5 End points
    E.5.1Primary end point(s)
    The number of treated spontaneous and traumatic bleeding episodes.
    Il numero di episodi di sanguinamento spontaneo e traumatico trattati.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On demand (arm 1): From randomisation (week 0) up until start of concizumab treatment (at least 24 weeks)
    Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the primary analysis cut-off (at least 32 weeks)
    On-demand (braccio 1): dalla randomizzazione (settimana 0) fino all'inizio del trattamento con concizumab (almeno 24 settimane)
    Concizumab (braccio 2): dall'inizio del nuovo regime di dosaggio di concizumab (settimana 0) fino all'interruzione dell'analisi primaria (almeno 32 settimane)
    E.5.2Secondary end point(s)
    1. Change in 36 Item short form health survey version 2 (SF36v2) bodily pain
    2. Change in SF36v2 physical functioning
    3. Number of treated spontaneous bleeding episodes
    4. Number of treated joint bleeds
    5. Number of treated target joint bleeds
    6. Number of thromboembolic events
    7. Number of thromboembolic events
    8. Number of hypersensitivity type reactions
    9. Number of hypersensitivity type reactions
    10. Number of injection site reactions
    11. Number of injection site reactions
    12. Number of patients with antibodies to concizumab
    13. Number of patients with antibodies to concizumab
    14. Pre-dose (trough) concizumab plasma concentration (Ctrough)
    15. Pre-dose peak thrombin generation
    16. Pre-dose free tissue factor pathway inhibitor (TFPI) concentration
    17. Maximum concizumab plasma concentration (Cmax)
    18. Area under the concizumab plasma concentration-time curve (AUC)
    1. Variazione del dolore fisico registrato nelle 36 voci in forma abbreviata versione 2 (SF36v2)
    2. Variazione della funzionalità fisica registrata nel questionario di SF36v2
    3. Numero di episodi di sanguinamento spontaneo trattati
    4. Numero di sanguinamenti articolari trattati
    5. Numero di sanguinamenti alle target joint trattati
    6. Numero di eventi tromboembolici
    7. Numero di eventi tromboembolici
    8. Numero di reazioni di tipo ipersensibilità
    9. Numero di reazioni di tipo ipersensibilità
    10. Numero di reazioni nel sito di iniezione
    11. Numero di reazioni nel sito di iniezione
    12. Numero di pazienti con anticorpi contro concizumab
    13. Numero di pazienti con anticorpi contro concizumab
    14. Concentrazione plasmatica di pre-dose (trough) di concizumab (Ctrough)
    15. Generazione di picco di trombina pre-dose
    16. Concentrazione pre-dose di inibitori della via del fattore di tessuto libero (TFPI)
    17. Massima concentrazione plasmatica di concizumab (Cmax)
    18. Area al di sotto della curva concentrazione plasmatica-tempo di concizumab (AUC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2:Start of treatment (week (wk) 0), wk 24
    3-5:
    On demand (arm 1): Randomisation (wk 0) to start of concizumab (min. 24 wks)
    Concizumab (arm 2): Start of new concizumab dosing (wk 0) to primary analysis cut-off (min. 32 wks)
    6, 8, 10 & 12:
    On demand (arm 1 main part):
    -Randomisation to on demand treatment to start of concizumab
    Concizumab (arms 2-4):
    -Before pause: Start of concizumab (wk 0) to 7 wks after treatment pause
    -After pause: From start of concizumab (wk 0) to primary analysis cutoff (min. 32 wks)
    7, 9, 11 & 13:
    Concizumab:
    -Before pause: Start of treatment (wk 0) to 7 wks after treatment pause
    -After pause: Start of concizumab to end of trial (wk 167)
    14-16: Prior to concizumab dose at wk 24 (after restart)
    17-18: 0-24 hrs (0: time of concizumab dose at wk 24 (after restart))
    1-2:Da inizio trattamento(sett.0),sett.24
    3-5:braccio1:da randomizzazione(sett.0)a inizio concizumab-min.24 sett.
    braccio2:da inizio nuovo dosaggio concizumab(sett.0)a cut-off analisi primaria-min.32 sett.
    6,8,10,12:braccio1parte principale dello studio:da randomizzazione a inizio concizumab
    Concizumab(braccio2-4):
    -Pre pausa:da inizio concizumab(sett.0)a7sett.dopo pausa trattamento
    -Post pausa:da inizio concizumab(sett.0)a cut-off analisi primaria-min.32sett.
    7,9,11,13:Concizumab:
    -Prima della pausa:da inizio trattamento(sett.0)a7sett.dopo pausa trattamento
    -Dopo la pausa:da inizio concizumab a fine sperimentazione(sett.167)
    14-16:prima della dose di concizumab alla sett.24(dopo il riavvio)
    17-18:0-24 ore(0:tempo somministrazione concizumab alla sett.24(dopo il riavvio))
    sett.=settimana/e
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 Yes
    E.8.1.7.1Other trial design description
    due bracci randomizzati (in profilassi e non in profilassi)e due bracci non randomizzati.
    2 randomised treatment arms (ppx/no ppx) and two non-randomised treatment arms
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    I pazienti saranno quindi suddivisi nei diversi bracci dello studio sulla base del regime di trattam
    Treatment regimen before entering the trial will determine the assignment to the four treatment arms
    E.8.2.4Number of treatment arms in the trial4
    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 EEA59
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Algeria
    Australia
    Canada
    India
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Russian Federation
    Serbia
    South Africa
    Turkey
    Ukraine
    United States
    Norway
    European Union
    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
    Last Patient Last Visit (LPLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 96
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 136
    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
    nessuno
    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 Decision2019-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-24
    P. End of Trial
    P.End of Trial StatusRestarted
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