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    EudraCT Number:2011-005040-10
    Sponsor's Protocol Code Number:PRO045-CLIN-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-02-27
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-005040-10
    A.3Full title of the trial
    A phase I/II, open-label study to assess the efficacy, safety, pharmacodynamics and pharmacokinetics of multiple doses of PRO045 in subjects with Duchenne muscular dystrophy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test if multiple injections of PRO045 are safe and effective in people who suffer from Duchenne muscular dystrophy
    A.4.1Sponsor's protocol code numberPRO045-CLIN-01
    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 SponsorProsensa Therapeutics BV
    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 supportProsensa Therapeutics BV
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProsensa Therapeutics BV
    B.5.2Functional name of contact pointClinical department
    B.5.3 Address:
    B.5.3.1Street AddressJ.H. Oortweg 21
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CH
    B.5.4Telephone number310713322100
    B.5.5Fax number310713322088
    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/3/12/991
    D.3 Description of the IMP
    D.3.1Product namePRO045
    D.3.2Product code PRO045
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPS220
    D.3.9.2Current sponsor codePS220
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Duchenne muscular dystrophy resulting from a mutation correctable by PRO045-induced DMD exon 45 skipping
    Distrofia muscolare di Duchenne risultante da una mutazione correggibile con il salto dell’esone 45 indotto da PRO045
    E.1.1.1Medical condition in easily understood language
    Duchenne muscular dystrophy
    Distrofia muscolare di Duchenne
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10013801
    E.1.2Term Duchenne muscular dystrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of PRO045 after 48 weeks treatment in ambulant subjects with Duchenne muscular dystrophy.
    Valutare l’efficacia di PRO045 dopo 48 settimane di trattamento in soggetti in grado di deambulare affetti da distrofia muscolare di Duchenne.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of PRO045 after 48 weeks of treatment in all study subjects with Duchenne muscular dystrophy including subjects from the dose-escalation phase of the study.

    To determine the pharmacokinetics of PRO045 at different dose levels after subcutaneous administration in subjects with Duchenne muscular dystrophy.

    To assess the pharmacokinetics, bioavailability and safety of PRO045 following single intravenous dose administration at different dose levels.

    To assess the pharmacodynamics of PRO045 at different dose levels after subcutaneous administration in subjects with Duchenne muscular dystrophy.

    To assess trend in efficacy in all subjects with Duchenne Muscular Dystrophy not included in the primary objective after 48 weeks of treatment.
    Valutare la sicurezza e la tollerabilità di PRO045 dopo 48 settimane di trattamento in tutti i soggetti dello studio affetti da distrofia muscolare di Duchenne, inclusi i soggetti provenienti dalla fase di incremento della dose dello studio.
    Determinare la farmacocinetica di PRO045 a diversi livelli di dosaggio dopo somministrazione per via sottocutanea in soggetti affetti da distrofia muscolare di Duchenne.
    Valutare la farmacocinetica, la biodisponibilità e la sicurezza di PRO045 a seguito di una singola somministrazione di una dose per via endovenosa a diversi livelli di dosaggio.
    Valutare la farmacodinamica di PRO045 a diversi livelli di dosaggio dopo una somministrazione per via sottocutanea in soggetti affetti da distrofia muscolare di Duchenne.
    Valutare il trend di efficacia in tutti i soggetti affetti da distrofia muscolare di Duchenne non inclusi nell'obiettivo primario dopo 48 settimane di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Duchenne muscular dystrophy resulting from a mutation correctable by treatment with PRO045 confirmed by a state-of-the-art DNA diagnostic technique covering all DMD gene exons, including but not limited to MLPA (Multiplex Ligation-dependent Probe Amplification), CGH (Comparative Genomic Hybridisation), SCAIP (Single Condition Amplification/Internal Primer) or HRMCA (High-Resolution Melting Curve Analysis).

    Ambulant boys aged at least 5 years on the day of first dosing able to walk for at least 230 meters in the 6 minute walking distance (6MWD) at the first screening visit and also at the baseline visit. In addition, 2 of the 3 pre-treatment 6MWD tests (screen 1, screen 2, baseline) must be within ± 30 meters of each other prior to first PRO045 administration.

    Adequate quality for biopsy (confirmed with MRI) of the lateral head of the gastrocnemius muscle. An alternative muscle may be considered for biopsy but only following discussion between the Principal Investigator and the Prosensa Medical Monitor.

    Life expectancy of at least 3 years after inclusion in the study.

    Glucocorticosteroid use which is stable for at least 3 months prior to first PRO045 administration. Subjects must have been receiving glucocorticosteroids for at least 6 months prior to the first PRO045 administration.

    Willing and able to adhere to the study visit schedule and other protocol requirements.

    Written informed consent signed (by parent(s)/legal guardian and/or the subject, according to the local regulations).

    In France, a subject will be eligible for inclusion in this study only if either affiliated to, or a beneficiary of, a social security category.
    1. Distrofia muscolare di Duchenne causata da una mutazione correggibile mediante trattamento con PRO045, confermata da una tecnica diagnostica sul DNA all’avanguardia che analizza tutti gli esoni del gene della distrofia muscolare di Duchenne (DMD), tra cui e non in via esclusiva i test MLPA (Multiplex Ligation-dependent Probe Amplification [amplificazione legatura-dipendente multipla della sonda]), CGH (Comparative Genomic Hybridisation [ibridazione comparativa del genoma]), SCAIP (Single Condition Amplification/Internal Primer) o HRMCA (High-Resolution Melting Curve Analysis [analisi della curva di dissociazione ad alta risoluzione]).
    2. Bambini in grado di deambulare, che al momento della prima somministrazione abbiano almeno 5 anni compiuti e che siano in grado di percorrere almeno 230 metri nel test del cammino in 6 minuti (6MWD) alla prima visita di screening e anche alla visita di baseline. Inoltre, 2 dei 3 test 6MWD pre-trattamento (screen 1, screen 2, baseline) devono avvenire entro ±30 metri l'uno dall'altro prima della prima somministrazione di PRO045.
    3. Qualità adatta alla biopsia (confermata tramite RMI) del capo laterale del muscolo gastrocnemio. Per la biopsia può essere considerato un muscolo alternativo, ma solo a seguito di una discussione tra lo Sperimentatore principale e il responsabile del monitoraggio medico di Prosensa.
    4. Aspettativa di vita di almeno 3 anni successivamente all’inclusione nello studio.
    5. Uso di glucocorticosteroidi stabile da almeno 3 mesi prima della prima somministrazione di PRO045. I soggetti devono aver ricevuto glucocorticosteroidi per almeno 6 mesi prima della prima somministrazione di PRO045.
    6. Disponibilità e capacità di rispettare il programma delle visite dello studio e gli altri requisiti del protocollo.
    7. Consenso informato scritto firmato (dal/i genitore/i, tutore legale e/o dal soggetto, in conformità alle normative locali).
    E.4Principal exclusion criteria
    Known presence of dystrophin in ≥5% of fibres in a pre-study diagnostic muscle biopsy (i.e. historic muscle biopsy taken prior to written informed consent for this study).

    Current or history of liver disease or impairment.

    Current or history of renal disease or impairment.

    At least two aPTT above ULN within the last month.

    Screening platelet count below the lower limit of normal (LLN).

    Acute illness within 4 weeks prior to first dose of PRO045 which may interfere with the study assessments.

    Severe mental retardation or behavioural problems which, in the opinion of the investigator, prohibit participation in this study.

    Severe cardiomyopathy which in the opinion of the investigator prohibits participation in this study. If a subject has a left ventricular ejection fraction <45% at screening, the investigator should discuss inclusion of the subject with the Medical Monitor.

    Expected need for daytime mechanical ventilation within the next year.

    Use of anticoagulants, antithrombotics or antiplatelet agents.

    Use of idebenone or other forms of coenzyme Q10 within 1 month prior to the start of the screening for the study.

    Use of nutritional or herbal supplements which, in the opinion of the investigator, may influence muscle performance, within1 month of the study

    Use of any other investigational product or participation in another trial with an investigational product, within 6 months prior to the start of the screening for the study.
    1. Presenza nota di distrofina in ≥5% delle fibre risultante da una biopsia muscolare diagnostica precedente allo studio (ovvero una biopsia muscolare anamnestica prelevata prima della firma del consenso informato per questo studio).
    2. Malattia o insufficienza epatica in corso o passata.
    3. Malattia o insufficienza renale in corso o passata.
    4. Almeno due aPTT oltre il limite superiore (ULN, upper limit of normal)entro l’ultimo mese.
    5. Conta piastrinica allo screening al di sotto del limite inferiore dell’intervallo di normalità (LLN, lower limit of normal).
    6. Patologie acute insorte nelle 4 settimane precedenti alla prima somministrazione di PRO045, che potrebbero interferire con le valutazioni dello studio.
    7. Grave ritardo mentale o problemi comportamentali che, a parere dello sperimentatore, impediscono la partecipazione a questo studio.
    8. Grave cardiomiopatia che a parere dello sperimentatore impedisce la partecipazione a questo studio. Se un soggetto ha una frazione di eiezione ventricolare sinistra <45% allo screening, lo sperimentatore dovrebbe discutere l’inclusione del soggetto con il responsabile del monitoraggio medico.
    9. Necessità di ventilazione meccanica diurna prevista nel corso dell’anno successivo.
    10. Uso di agenti anticoagulanti, antitrombotici o antipiastrinici.
    11. Uso di idebenone o di altre forme del coenzima Q10 nel corso del mese precedente l’inizio dello screening per lo studio.
    12. Uso di altri integratori nutrizionali o a base di erbe che, secondo il parere dello sperimentatore, potrebbero influenzare le prestazioni muscolari, entro 1 mese dello studio.
    13. Uso di altri prodotti sperimentali o partecipazione ad uno studio con un altro prodotto
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in 6MWD after 48 weeks of treatment phase at the selected dose
    Variazione dalla baseline nel test 6MWD dopo una fase di trattamento di 48 settimane al dosaggio selezionato
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 48 weeks of treatment phase .
    a 48 settimane di trattamento
    E.5.2Secondary end point(s)
    • Muscle function (North Star Ambulatory Assessment, Timed tests, 6MWD)
    • Muscle strength (spirometry, handheld myometry)
    • Performance of upper limb (PUL)
    • DMD Functional Outcomes Questionnaire (DMD-FOS)
    • Exploratory efficacy endpoints:
    - Accelerometry
    - Myotools (grip strength, key pinch, moviplate)

    Safety parameters:
    • Adverse events
    • Local tolerability
    • Laboratory assessments including:
    - Routine biochemistry and haematology
    - Urinalysis (routine parameters plus α1-microglobulin, microscopy) and 24-hour urine (additionally including protein electrophoresis, urine cystatin, KIM-1 and exploratory measurement of specific DMD protein biomarkers and micro RNAs)
    - Coagulation parameters (aPTT, PTT [INR], fibrinogen)
    - Complement split products (C3a, SC5b-9, Bb)
    - Pro inflammatory markers (cytokines IL-6, TNF-α and chemokine MCP-1)
    • Anti-dystrophin antibodies
    • ECG parameters
    • Vital signs (temperature, blood pressure, pulse rate, respiration rate)
    • Echocardiography
    • Physical examination and DEXA
    • Standard renal ultrasound

    Pharmacokinetic parameters
    • t ½
    • AUC: 0-24h, 0-7d, 0-∞
    • Cmax, Ctrough, 7d
    • tmax
    • Vd/F (Volume of distribution)
    • CL/F (clearance)
    • PRO045 levels in urine
    • PRO045 levels in muscle tissue

    Pharmacodynamic parameters:
    • Presence of (BMD-like) dystrophin expression after treatment (in muscle biopsy)
    • Histological and immunological staining on cross-sections of muscle tissue
    • Production of exon skip 45 mRNA (in muscle biopsy)
    • Exploratory PD endpoints:
    - Nuclear Magnetic Resonance imaging and spectroscopy (MRI and MRS)
    - Exploratory biomarkers(e.g. TIMP, MMP-9, miR-1, miR-133)
    – Efficacia:
    - Funzione muscolare (scala di valutazione North Star [North Star Ambulatory Assessment], test cronometrici, 6MWD)
    - Forza muscolare (spirometria, miometria manuale)
    - Prestazioni degli arti superiori (PUL, Performance of Upper Limb)
    - Questionario sui risultati funzionali della DMD (DMD-FOS, DMD Functional Outcomes Questionnaire)
    Endpoint di efficacia esplorativi:
    - Accelerometria
    - Dispositivi muscolari (forza di afferrare, presa a pinza, dispositivo MoviPlate)
    – Parametri di sicurezza:
    - Eventi avversi
    - Tollerabilità locale
    - Valutazioni di laboratorio, tra cui:
    - Biochimica ed ematologia di routine
    - Analisi delle urine (parametri di routine più α1-microglobulina, microscopia) e test dell’urina nelle 24 ore (compresa elettroforesi proteica, cistatina C, proteina KIM1 e misurazione esplorativa di biomarcatori specifici della proteina DMD e micro RNA)
    - Parametri di coagulazione (aPTT, PTT [INR], fibrinogeno)
    - Prodotti di scissione del complemento (C3a, SC5b-9, Bb)
    - Marcatori pro-infiammatori (citochine IL-6, TNF-α e chemochina MCP-1)
    - Anticorpi anti-distrofina
    - Parametri ECG
    - Segni vitali (temperatura, pressione sanguigna, frequenza cardiaca, frequenza respiratoria)
    - Ecocardiogramma
    - Esame obiettivo e DEXA
    - Ecografia renale color Doppler
    – Parametri di farmacocinetica:
    - t ½
    - AUC: 0-24 h, 0-7 gg, 0-∞
    - Cmax, Ctrough, 7gg
    - tmax
    - Vd/F(Volume di distribuzione)
    - CL/F (clearance)
    - Livelli di PRO045 nelle urine
    - Livelli di PRO045 nei tessuti muscolari
    – Parametri farmacodinamici:
    - Presenza di un’espressione della distrofina (BMD-simile) dopo il trattamento (nella biopsia muscolare)
    - Colorazione istologica e immunologica sulle sezioni trasversali del tessuto muscolare
    - Produzione di mRNA saltando l’esone 45 (nella biopsia muscolare)
    - Endpoint esplorativi di PD:
    - Risonanza magnetica nucleare per immagini e spettroscopia (RMI e RMS)
    - - Biomarcatori esplorativi (ad es. TIMP, MMP9, miR1, miR-133)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: at all available study visits
    Safety: at all time points
    Pharmacokinetic parameters: at all available study visits
    Pharmacodynamic parameters: at all available study visits
    – Efficacia: in occasione di tutte le visite dello studio disponibili
    – Sicurezza: a tutti i time points
    – Parametri di Farmacocinetica: a tutte le visite disponibili
    – Parametri di Farmacodinamica: a tutte le visite disponibili
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last Subject Last Visit
    ultima visita dell'ultimo paziente (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial 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 Yes
    F.1.1Number of subjects for this age range: 45
    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) Yes
    F. of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 5
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 Yes
    F. of subjects incapable of giving consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    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)
    Dependent on emerging safety and/or PD data from the PRO045 development program, the subjects in this study may be offered the potential for further longer-term dosing with PRO045. Any further dosing and assessments after completion of the 48-week treatment phase will be presented and justified either within an amendment to this protocol or by a new clinical study protocol.
    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 Decision2013-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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