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    Summary
    EudraCT Number:2014-002288-14
    Sponsor's Protocol Code Number:SD-005
    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:2016-08-05
    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 number2014-002288-14
    A.3Full title of the trial
    A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa
    Estudio de fase III, multicéntrico, aleatorizado, doble ciego y controlado con placebo, sobre la eficacia y seguridad de la crema SD-101 en pacientes con epidermólisis ampollosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Investigation into the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa
    Investigación de la eficacia y seguridad de la crema SD-101 en pacientes con epidermólisis ampollosa
    A.3.2Name or abbreviated title of the trial where available
    Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa
    Estudio de efectividad y seguridad de SD-101 en sujectos con elpidermólisis bullosa
    A.4.1Sponsor's protocol code numberSD-005
    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 SponsorScioderm, 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 supportScioderm, INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationScioderm, INC.
    B.5.2Functional name of contact pointRobert Ryan
    B.5.3 Address:
    B.5.3.1Street Address1007 Slater Road, Suite 170
    B.5.3.2Town/ cityDurham
    B.5.3.3Post codeNC 27703
    B.5.3.4CountryUnited States
    B.5.4Telephone number0034620983130
    B.5.5Fax number001919294-4416
    B.5.6E-mailrobert.ryan@sderm.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/145/13
    D.3 Description of the IMP
    D.3.1Product nameZorblisa
    D.3.2Product code SD-101
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALLANTOIN
    D.3.9.1CAS number 97-59-6
    D.3.9.3Other descriptive nameALLANTOIN
    D.3.9.4EV Substance CodeSUB12779MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Epidermolysis Bullosa
    Epidermólisis bullosa
    E.1.1.1Medical condition in easily understood language
    Genetic skin fragility disorder
    enfermedad genética de fragilidad de la piel
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10014989
    E.1.2Term Epidermolysis bullosa
    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
    The primary objective is to evaluate the efficacy and safety of SD-101-6.0vs. SD- 101-0.0 (placebo) in patients with Simplex, Recessive Dystrophic, or Junctional non Herlitz Epidermolysis Bullosa. The primary endpoint is the complete closure of the patient's target wound.
    El objetivo principal es evaluar la eficacia y seguridad de SD-101-6.0 frente a SD-101-0.0 (placebo) en pacientes con epidermólisis ampollosa simple, distrófica recesiva y juntural tipo no-Herlitz. El criterio principal de valoración es el cierre completo de la herida específica del paciente en dos meses.
    E.2.2Secondary objectives of the trial
    Not Applicable
    No proced
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed Consent form signed by the patient or patient's legal representative;
    also, if the patient is under the age of majority but capable of providing assent,
    signed assent from the patient.
    2. Patient (or caretaker) must be willing to comply with all protocol requirements.
    3. Diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB.
    4. Patient must have 1 target wound (size 10 to 50 cm 2 ).
    5. Patients 1 month and older.
    6. Target wound must be present for 21 days or more.
    1. Consentimiento informado firmado por el paciente o por el representante legal del paciente; si el paciente es menor de 18 años de edad pero es capaz de dar su asentimiento, asentimiento firmado por el paciente.
    2. El paciente (o su cuidador) debe estar dispuesto a cumplir todos los requisitos del protocolo.
    3. Diagnóstico de EA simple, distrófica recesiva o juntural tipo no-Herlitz.
    4. Los pacientes deben tener una herida específica (10 a 50 cm2 de tamaño).
    5. Pacientes de 1 mes o más de edad.
    6. La herida específica debe tener una duración de 21 días o más.
    E.4Principal exclusion criteria
    1. Patients who do not meet the entry criteria outlined above.
    2. Selected target wound cannot have clinical evidence of local infection.
    3. Use of any investigational drug within the 30 days before enrollment.
    4. Use of immunotherapy or cytotoxic chemotherapy within the 60 days before
    enrollment.
    5. Use of systemic or topical steroidal therapy within the 30 days before enrollment.
    (Inhaled steroids and ophthalmic drops containing steroids are allowed)
    6. Use of systemic antibiotics within the 7 days before enrollment.
    7. Current or former malignancy.
    8. Arterial or venous disorder resulting in ulcerated lesions.
    9. Pregnancy or breastfeeding during the study. (A urine pregnancy test will be
    performed at screening and every 30 days until the final visit for female patients
    of childbearing potential)
    10. Females of childbearing potential who are not abstinent and not practicing a
    medically acceptable method of contraception.
    1. Pacientes que no cumplan los criterios de inclusión especificados con anterioridad.
    2. La herida específica seleccionada no debe tener signos clínicos de infección local.
    3. Uso de cualquier fármaco en fase de investigación en los 30 días previos a la inclusión.
    4. Uso de inmunoterapia o quimioterapia citotóxica en los 60 días previos a la inclusión.
    5. Uso de tratamiento esteroideo tópico o sistémico en los 30 días previos a la inclusión. (Se permiten los esteroides inhalados o los colirios oftálmicos que contienen esteroides.)
    6. Uso de antibióticos sistémicos en los 7 días previos a la inclusión.
    7. Neoplasia maligna actual o anterior.
    8. Trastorno arterial o venoso que provoca lesiones ulceradas.
    9. Embarazo o lactancia durante el estudio. (En el caso de las pacientes en edad fértil, se realizará una prueba de embarazo en orina en la selección y cada 30 días hasta la visita final.)
    10. Mujeres en edad fértil que no se abstengan de tener relaciones sexuales y no empleen un método de anticoncepción aceptable.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the complete closure of the patient's target wound. Complete target
    wound closure is defined as skin reepithelialization without drainage.
    El criterio principal de valoración es el cierre completo de la herida específica del paciente. El cierre completo de la herida específica se define como la reepitelización de la piel, sin drenaje
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy analysis will compare the proportion of patients achieving this endpoint within two months.
    El análisis principal de la eficacia comparará la proporción de pacientes que alcanza este criterio de valoración en dos meses.
    E.5.2Secondary end point(s)
    The secondary endpoints include the estimation of body surface area (BSA) coverage of lesional skin, and assessment of itching, pain, and scarring.
    Los criterios secundarios de valoración incluyen el cálculo de cobertura de SC de piel afectada por lesiones y la evaluación del picor y el dolor.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Median Time to Complete Target Wound Closure
    Change in lesional skin based on BSA estimates at
    Month 3, compared to Baseline.
    Change in itching assessed at Day 7, compared to Baseline.
    Change in pain assessed at Day 7, compared to Baseline.
    Mediana del tiempo transcurrido hasta el cierre completo de la herida específica.
    Cambio en la piel afectada por lesiones en base a los cálculos de la SC en el mes 3, en comparación con el periodo basal.
    Cambio en el picor evaluado el día 7, en comparación con el periodo basal.
    Cambio en el dolor evaluado el día 7, en comparación con el periodo basal.
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned 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 EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    France
    Italy
    Netherlands
    Poland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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: 90
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 15
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 22
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 24
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 29
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 90
    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)
    The patients from study SD-005 will be offered to roll-over into an open-label extension study (Study SD-006) to continue treatment with SD-101-6.0 to collect long term safety data. If they choose not to participate, patients will return to normal standard of care.
    Los paciente del estudio SD-005 tendrán la posibilidad de participar en el estudio de extensión abierto (estudio SD-006) para continuar con el tratamiento con SD-101-6.0 y recoger datos de seguridad a largo plazo. Si el paciente opta por not participar en el estudio de extensión, volverá a su tratamiento standard
    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 Decision2016-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-05
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