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    Summary
    EudraCT Number:2013-001152-35
    Sponsor's Protocol Code Number:UX003-CL201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-001152-35
    A.3Full title of the trial
    An Open-Label Phase 1/2 Study to Assess the Safety, Efficacy and Dose of UX003 rhGUS Enzyme Replacement Therapy in Patients with MPS 7
    Estudio abierto de fase 1/2 para evaluar la seguridad, la eficacia y la dosis de la terapia sustitutiva enzimática con la GUShr UX003 en pacientes con MPS VII
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A safety and efficacy study in MPS 7 patients receiving enzyme (UX003) replacement by intravenous injection
    Un estudio de seguridad y eficacia en pacientes con MPS VII tratados con una enzima (UX003) sustitutiva por vía intravenosa
    A.4.1Sponsor's protocol code numberUX003-CL201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01856218
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUltragenyx Pharmaceutical 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 supportUltragenyx Pharmaceutical Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUltragenyx Pharmaceutical Inc.
    B.5.2Functional name of contact pointClinical Operation
    B.5.3 Address:
    B.5.3.1Street Address60 Leveroni Court
    B.5.3.2Town/ cityNovato, CA
    B.5.3.3Post code94949
    B.5.3.4CountryUnited States
    B.5.4Telephone number34917088600
    B.5.6E-mailschesler@ultragenyx.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/3/12/973
    D.3 Description of the IMP
    D.3.1Product nameRecombinant human beta-glucuronidase
    D.3.2Product code UX003
    D.3.4Pharmaceutical form 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 INNNot available
    D.3.9.2Current sponsor codeUX003
    D.3.9.3Other descriptive nameRECOMBINANT HUMAN BETA GLUCURONIDASE; RHGUS
    D.3.9.4EV Substance CodeSUB128266
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mucopolysaccharidosis type 7 (MPS 7, Sly syndrome)
    Mucopolisacaridosis de tipo VII (MPS VII, síndrome de Sly)
    E.1.1.1Medical condition in easily understood language
    Mucopolysaccharidosis type 7 (MPS 7, Sly syndrome)
    Mucopolisacaridosis de tipo VII (MPS VII, síndrome de Sly)
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the study are to evaluate:
    -Safety and tolerability of UX003 exposure.
    -Efficacy as determined by the reduction of total urinary GAG (uGAG) excretion.
    Los objetivos principales son evaluar:
    -La seguridad y la tolerabilidad de la exposición al UX003.
    -La eficacia según lo determinado por la reducción de la excreción de GAG urinarios (GAGu) totales.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the effect of rhGUS on:
    -Total uGAG excretion to assess the optimal dose using a forced dose titration regimen.
    -Walking capacity as measured by the 6 Minute Walk Test (6MWT).
    -Stair climbing capacity as measured by the 3 Minute Stair Climb Test (3MSCT).
    -Pulmonary function as measured by forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and maximum voluntary ventilation in one minute (MVV1).
    -Height and weight growth velocity compared to estimated pretreatment growth rate velocity from medical records (prepubertal pediatric patients only).
    -Shoulder range of motion as measured by goniometry.
    Los objetivos secundarios son evaluar el efecto de la GUShr en:
    -La excreción de GAGu totales para evaluar la dosis óptima utilizando un esquema de ajuste forzado de la dosis.
    -La capacidad de marcha según lo determinado mediante la prueba de marcha de 6 minutos (6 Minute Walk Test, 6MWT).
    -La capacidad de subir escaleras según lo determinado mediante la prueba de subir escaleras de 3 minutos (3 Minute Stair Climb Test, 3MSCT).
    -La función pulmonar según lo determinado por la capacidad vital forzada (CVF), el volumen espiratorio máximo en un segundo (VEM1) y la ventilación voluntaria máxima en un minuto (VVM1).
    -La velocidad de crecimiento en peso y talla en comparación con la velocidad de crecimiento estimada previa al tratamiento obtenida de la historia clínica (solo pacientes pediátricos en edad prepuberal).
    -La amplitud de movimiento de hombros según lo determinado mediante goniometría.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Individuals eligible to participate in this study must meet all of the following inclusion criteria:
    -Confirmed diagnosis of MPS 7 based on leukocyte or fibroblast glucuronidase enzyme assay or genetic testing confirming diagnosis.
    -Elevated uGAG excretion at a minimum of 2-fold over the mean normal for age.
    -Between 5 and 30 years of age, inclusive.
    -Willing and able to provide written, signed informed consent, or in the case of subjects under the age of 18 (or 16 years, depending on the region), provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
    -Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study.
    -Females of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have had total hysterectomy, have been in menopause for at least two years, or have had tubal ligation at least one year prior to Screening.
    Las personas aptas para participar en este estudio deben cumplir todos los siguientes criterios de inclusión:
    -Diagnóstico confirmado de MPS VII basado en la determinación enzimática de glucuronidasa en leucocitos o fibroblastos o en el análisis genético que confirme el diagnóstico.
    -Excreción elevada de GAGu a un mínimo de 2 veces la media normal para la edad.
    -Entre 5 y 30 años de edad, inclusive.
    -Voluntad y capacidad para dar su consentimiento informado por escrito firmado o, en el caso de pacientes menores de 18 años (o de 16, según la región), para proporcionar asentimiento por escrito (si es necesario) y consentimiento informado por escrito firmado por un representante legalmente autorizado después de que se les haya explicado la naturaleza del estudio y antes de que se efectúe cualquier procedimiento relacionado con la investigación.
    -Los pacientes sexualmente activos deben estar dispuestos a usar un método anticonceptivo aceptable durante su participación en el estudio.
    -Las mujeres con capacidad para procrear deben obtener un resultado negativo en la prueba de embarazo en la selección y estar dispuestas a hacerse otras pruebas de embarazo durante el estudio. Las mujeres a las que se considera sin capacidad para procrear son aquellas que se han sometido a una histerectomía total, que tengan menopausia desde hace al menos dos años o que se hayan sometido a una ligadura de trompas al menos un año antes de la selección.
    E.4Principal exclusion criteria
    Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
    -Has undergone a successful bone marrow or stem cell transplant or has any degree of detectable chimaerism with donor cells.
    -Any hypersensitivity to rhGUS or its excipients that, in the judgment of the Investigator, place the subject at increased risk for adverse effects.
    -Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study.
    -Use of any investigational product (drug or device or combination product) within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments at any time during the study.
    -Has a condition of such severity and acuity, in the opinion of the Investigator, that it warrants immediate surgical intervention or other treatment or may not allow safe study participation.
    -Has a concurrent disease or condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study, or would interfere with study participation or affect safety.
    Las personas que cumplan alguno de los siguientes criterios de exclusión no serán aptas para participar en el estudio:
    -Se ha sometido a un trasplante exitoso de médula ósea o células madre, o tiene algún grado de quimerismo detectable con células del donante.
    -Cualquier hipersensibilidad conocida a la GUShr o sus excipientes que, en opinión del investigador, aumenta el riesgo del paciente de sufrir efectos adversos.
    -Está embarazada o en período de lactancia en la selección o planea quedar embarazada (la paciente o la pareja de un paciente) en cualquier momento durante el estudio.
    -Uso de un producto en fase de investigación (medicamento o dispositivo, o combinación) dentro de los 30 días anteriores a la selección o necesidad de un fármaco en fase de investigación antes de finalizar todas las evaluaciones programadas del estudio en cualquier momento durante su transcurso.
    -Tiene una enfermedad de tal gravedad e intensidad que, en opinión del investigador, justifica una intervención quirúrgica inmediata o cualquier otro tratamiento o puede impedir la participación segura en el estudio.
    -Tiene una enfermedad o un trastorno concurrente que, en opinión del investigador, pone al paciente en un alto riesgo de no cumplir adecuadamente con el tratamiento o de no completar el estudio o que podría interferir en la participación en el estudio o comprometer la seguridad.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of this study are:
    -Safety of UX003 as measured by the incidence and frequency of AEs and serious adverse events (SAEs), including clinically significant changes from Baseline to scheduled time points in Medical history, Physical examination findings, Vital signs, Clinical laboratory evaluations, Concomitant medications, Pregnancy testing/pregnancy of partner, IgG antibodies to rhGUS, Complement C3, C4 and CH50 (or CH100) levels.
    -Efficacy of UX003 as determined by mean change in total urinary glycosaminoglycan (uGAG) excretion from Week 0.
    Las variables principales de este estudio son:
    -La seguridad de UX003 se evaluará por la incidencia y la frecuencia de los acontecimientos adversos (AA) y los acontecimientos adversos graves (AAG), incluidos los cambios significativos de los valores iniciales respecto de los puntos de evaluación programados en antecedentes médicos, observaciones de la exploración física, constantes vitales, evaluaciones de laboratorio clínico, medicamentos concomitantes, pruebas de embarazo / embarazo de la pareja, anticuerpos IgG contra la GUShr, concentraciones de complemento C3, C4 y CH50 (o CH100).
    -La eficacia de UX003 determinada por el cambio medio en la excreción total urinaria de glucosaminoglucanos GAGu desde la semana 0.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Safety: Assessed up to Week 72. Serious adverse events (SAEs) will be recorded beginning at the time the subject signs the informed consent form (ICF) through 30 days following the last study visit. Non-serious AEs will be recorded from the time of signing the ICF through the last study visit.
    -Efficacy (total urinary GAG excretion): Urine samples will be collected every other week up to Week 36 and at Weeks 48, 60 and 72 in the extension phase, and 2 samples will be collected during the baseline week. The primary efficacy analysis will evaluate the mean change in urinary GAG excretion from Week 0 to Week 12.
    -Seguridad: Evaluados hasta la semana 72. Los acontecimientos adversos graves (AAG) se registrarán desde el momento en que el paciente firma el formulario de consentimiento informado (FCI) hasta 30 días después de la última visita del estudio. Los AA no graves se registrarán desde el momento en que se firma el FCI hasta la última visita del estudio.
    -Eficacia (excreción de GAG urinarios totales): las muestras de orina se recogerán cada dos semanas hasta la semana 36 y en las semanas 48, 60 y 72 en la fase de extensión, y dos muestras de orina se obtendrán durante la semana de inicio. El análisis principal de eficacia evaluará el cambio medio en la excreción de GAG urinarios desde la semana 0 hasta la semana 12.
    E.5.2Secondary end point(s)
    The secondary endpoints of this study are:
    -Walking capacity as measured by the 6 Minute Walk Test (6MWT).
    -Stair climbing capacity as measured by the 3 Minute Stair Climb Test (3MSCT).
    -Pulmonary function testing (spirometry) as measured by Forced Vital Capacity(FVC), Forced Expiratory Volume (FEV1) and Maximal Voluntary Ventilation (MVV1).
    -Growth velocity for height and weight as calculated from anthropometric measurements (standing height, either measured or derived from ulnar length measures and weight) and compared with pretreatment growth velocity when available.
    -Shoulder range of motion as measured by goniometry.
    -Optimal dose as determined by total urinary GAG excretion using a forced dose titration regimen.
    Las variables secundarias son:
    -La capacidad de marcha según lo determinado mediante la prueba de marcha de 6 minutos (6 Minute Walk Test, 6MWT).
    -La capacidad de subir escaleras según lo determinado mediante la prueba de subir escaleras de 3 minutos (3 Minute Stair Climb Test, 3MSCT).
    -La función pulmonar según lo determinado por la capacidad vital forzada (CVF), el volumen espiratorio máximo en un segundo (VEM1) y la ventilación voluntaria máxima en un minuto (VVM1).
    -La velocidad de crecimiento en peso y talla calculada mediante mediciones antropométricas (talla en bipedestación, ya sea medida o calculada a partir de la longitud del cúbito, y el peso) y en comparación con la velocidad del crecimiento previa al tratamiento, si estuviera disponible.
    -La amplitud de movimiento de hombros según lo determinado mediante goniometría.
    -Dosis óptima determinada por la excreción de GAG urinarios totales utilizando un esquema de ajuste forzado de la dosis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -6MWT: Assessed at 0, 6, 12, 22, 30, 36, 48, 60, 72 Weeks.
    -3MSCT: Assessed at 0, 6, 12, 22, 30, 36, 48, 60, 72 Weeks.
    -Pulmonary function testing (spirometry): Assessed at 0, 6, 12, 22, 30, 36, 48, 60, 72 Weeks.
    -Growth velocity for height and weight anthropometric measurements (standing height, either measured or derived from ulnar length measures and weight): Assessed at 0, 12, 22, 30, 36, 48, 60, 72 Weeks.
    -Shoulder range of motion as measured by goniometry: Assessed at 0, 6, 12, 22, 30, 36, 48, 60, 72 Weeks.
    -Optimal dose as determined by total uGAG excretion using a forced dose titration regimen up to Week 36.
    -6MWT: Evaluada en las semanas 0, 6, 12, 22, 30, 36, 48, 60, 72.
    -3MSCT: Evaluada en las semanas 0, 6, 12, 22, 30, 36, 48, 60, 72 .
    -Prueba de la función pulmonar (espirometría): Evaluada en las semanas 0, 6, 12, 22, 30, 36, 48, 60, 72.
    -Mediciones antropométricas para calcular la velocidad de crecimiento para peso y talla (talla en bipedestación, ya sea medida o calculada a partir de la longitud del cúbito, y el peso): Evaluadas en las semanas 0, 12, 22, 30, 36, 48, 60, 72.
    -Amplitud de movimiento de los hombros medida por goniometría: Evaluada en las semanas 0, 6, 12, 22, 30, 36, 48, 60, 72.
    -Dosis óptima determinada por la excreción de GAG urinarios totales utilizando un esquema de ajuste forzado de la dosis hasta la semana 36.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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 trial1
    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 EEA4
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 5
    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.1.1.5.1Number of subjects for this age range: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric patients.
    Pacientes pediátricos.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5
    F.4.2.2In the whole clinical trial 5
    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)
    Patients who complete all study requirements in Study UX003-CL201 may be eligible to participate in an extension study, if offered. However, patients are not obligated to participate in any additional studies, and the sponsor cannot guarantee that such studies will occur.
    Los pacientes que hayan completado todos lo requisitos del estudio UX003-CL201 podrían ser idóneos para participar en un estudio de extensión, en caso de que este tenga lugar. No obstante, los pacientes no están obligados a participar en estudios adicionales y el promotor no puede garantizar que estos estudios se realicen.
    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 Decision2014-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-13
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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