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    The EU Clinical Trials Register currently displays   42771   clinical trials with a EudraCT protocol, of which   7044   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-005679-96
    Sponsor's Protocol Code Number:SD-006
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-005679-96
    A.3Full title of the trial
    An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of ZorblisaTM (SD-101-6.0) in Patients with Epidermolysis Bullosa
    An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of ZorblisaTM (SD-101-6.0) in Patients with Epidermolysis Bullosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream
    used by Patients with Epidermolysis Bullosa.
    Sperimentazione per lo studio della sicurezza a lungo termine di Zorblisa (SD-101-6.0) crema utilizzata su pazienti con epidermolisi bollsa.
    A.3.2Name or abbreviated title of the trial where available
    Long-term Safety study of Zorblisa in Patients with Epidermolysis Bullosa
    Studio di sicurezza a lungo termine di Zorblisa in pazienti con Epidermolisi Bollosa
    A.4.1Sponsor's protocol code numberSD-006
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/266/2014
    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 pointJamie L. Gault
    B.5.3 Address:
    B.5.3.1Street Address4601 CREEKSTONE DRIVE SUITE 160
    B.5.3.2Town/ cityDurham
    B.5.3.3Post codeNC 27703
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019193282022
    B.5.5Fax number0019192944416
    B.5.6E-mailjamie.gault@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.3.4Pharmaceutical 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 INNALLANTOINA
    D.3.9.1CAS number 97-59-6
    D.3.9.2Current sponsor codeSD-101
    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 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 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
    Epidermolysis Bullosa
    Epidermolisi bollosa
    E.1.1.1Medical condition in easily understood language
    Genetic skin fragility disorder
    Disordine genetico che caus fragilit¿ della pelle
    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 20.0
    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 demonstrate the long-term safety of
    ZORBLISA in patients, with Simplex, Recessive Dystrophic and Junctional
    non-Herlitz Epidermolysis Bullosa.
    dimostrare la sicurezza a lungo termine di ZORBLISA in pazienti affetti da epidermolisi bollosa semplice, distrofica recessiva o giunzionale, di tipo non-Herlitz.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the efficacy of ZORBLISA in
    terms of the change in Body Surface Area (BSA) of lesional skin and
    wound burden; as well as closure of unhealed target wounds from the
    SD-005 study
    Gli obiettivi secondari comprendono la valutazione dell'efficacia di ZORBLISA in termini di variazioni dell¿area della superficie corporea (BSA) interessata dalla cute lesa e della portata della ferita, nonch¿ la rimarginazione delle ferite non guarite nel corso dello studio SD-005
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Informed Consent form signed by the patient or patient's legal representative; if the patient is under the age of 18 but capable of providing assent, signed assent from the patient.
    2. Patient (or caretaker) must be willing to comply with all protocol requirements.
    3. Patient who completed the SD-005 study (on study drug at Visit 5)
    1. Modulo di consenso informato firmato dal soggetto o dal suo rappresentante legale; qualora il soggetto sia minorenne ma in grado di fornire il proprio consenso, dovrà essere ottenuto un modulo di assenso firmato da quest’ultimo.
    2. Volontà da parte del soggetto (o del prestatore di cure) di ottemperare a tutti i requisiti del protocollo.
    3. Completamento dello studio SD-005 da parte del soggetto (in trattamento con il farmaco in studio alla Visita 5)
    E.4Principal exclusion criteria
    1. Patients who do not meet the entry criteria outlined in the Inclusion criteria.
    2. Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at the final visit for SD-005 for female patients of childbearing potential and repeated at Visit 1 if these visits do not occur on the same day)
    3. Females of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception.
    Mancata adesione ai criteri di inclusione di cui
    sopra.
    2. Gravidanza o allattamento nel corso dello
    studio (per le pazienti in età fertile, verrà
    eseguito un test di gravidanza sulle urine alla
    visita finale dello studio SD-005 e sarà ripetuto alla visita 1 se queste visite non avvengono nello stesso giorno).
    3. Mancato uso, da parte delle donne in età fertile,
    di un metodo contraccettivo accettabile, ivi
    compresa l’astinenza.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the long-term safety of ZORBLISA in patients with Simplex, Recessive Dystrophic, and Junctional non-Herlitz Epidermolysis Bullosa
    L'endpoint primario dello studio è dimostrare la sicurezza a lungo termine di ZORBLISA in pazienti affetti da epidermolisi bollosa semplice, distrofica recessiva o giunzionale, di tipo non-Herlitz
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety is assessed via monitoring of local tolerabilty at the application sites, occurrence of adverse events and physical examinations at Months 1,3,6,9,12,15,18, and 21
    La sicurezza sarà valutata in base alla tollerabilità locale della crema insorgenza eventi avversi ed esame fisico ai Mesi 1, 3, 6, 9, 12, 15, 18 e 21.
    E.5.2Secondary end point(s)
    The secondary endpoints include the change from baseline in BSA coverage of lesional skin and wound burden; as well as closure of unhealed target wounds from the SD-005 study.
    Gli endpoint secondari comprendono le variazioni dell'area della superficie corporea (BSA) interessata dalla cute lesa e della portata della ferita, nonch¿ la rimarginazione delle ferite non guarite nel corso dello studio SD-005
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change in lesional skin based on BSA estimates at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48 compared to Baseline.
    - Change in total corporal lesions based on BSA estimates at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48 compared to Baseline.
    - For target wounds that are not closed by the end of Study SD-005, the target wound area at the final visit for Study SD-005 will be used as the baseline
    area size of the target wound for SD-006. The unhealed target wound from SD-005 will be assessed at each subsequent scheduled visit until the target wound is documented as closed.
    Cambiamenti della cute lesa da valutare in base alla BSA ai mesi 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45 e 48 confrontata con il basale.
    - Cambiamenti nelle lesioni corporee totali da valutare in base alla BSA ai mesi 1, 3 , 6 , 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45 e 48 confrontata con il basale
    - Per le lesioni bersaglio non rimarginate alla fine dello studio SD-005, l'area delle lesioni bersaglio alla visita finale dello studio SD-005 sar¿ usata come dimensione di lesione basale per lo studio SD-006. Le ferite bersaglio verranno seguite durante ciascuna visita fino alla documentata completa chiusura
    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 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.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    Australia
    Austria
    Belgium
    Bulgaria
    France
    Germany
    Israel
    Italy
    Lithuania
    Netherlands
    Poland
    Romania
    Serbia
    Spain
    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
    Ultima visita dell'ultimo paziente
    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 months10
    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 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.1.1.1In 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: 14
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 59
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 27
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 150
    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 Decision2015-05-15
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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