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    Summary
    EudraCT Number:2022-001797-59
    Sponsor's Protocol Code Number:MOB015B-44-21-002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-11-16
    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 number2022-001797-59
    A.3Full title of the trial
    A multi-center, single-arm, open-label study to evaluate tolerability, safety, and efficacy of topical MOB015B solution in the treatment of mild to moderate distal subungual onychomycosis (DSO) in subjects aged 6-17 years
    Studio multicentrico, a braccio singolo, in aperto volto a valutare la tollerabilità, la
    sicurezza e l’efficacia della soluzione di MOB015B per uso topico nel trattamento
    dell’onicomicosi subungueale distale (OSD) da lieve a moderata in soggetti di età
    compresa tra 6 e 17 anni
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    non-controlled, open-label study to evaluate tolerability, safety, and efficacy of MOB015B solution for external use in the treatment of mild to moderate fungal infection of the nail in subjects aged 6-17 years
    Studio non controllato, in aperto volto a valutare la tollerabilità, la sicurezza e
    l’efficacia della soluzione di MOB015B per uso esterno nel trattamento di infezione
    fungina da lieve a moderata dell'unghia in soggetti di età compresa tra 6 e 17 anni
    A.3.2Name or abbreviated title of the trial where available
    N.A.
    N.A.
    A.4.1Sponsor's protocol code numberMOB015B-44-21-002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/450/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMoberg Pharma AB
    B.1.3.4CountrySweden
    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 supportMoberg Pharma AB (publ.)
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMoberg Pharma AB (publ.)
    B.5.2Functional name of contact pointCatrine Berlin
    B.5.3 Address:
    B.5.3.1Street AddressGustavslundsvägen 42, 5tr
    B.5.3.2Town/ cityBromma
    B.5.3.3Post code16751
    B.5.3.4CountrySweden
    B.5.4Telephone number0046725685361
    B.5.5Fax number00000000
    B.5.6E-mailcatrine.berlin@mobergpharma.se
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMOB015B
    D.3.2Product code [MOB015B]
    D.3.4Pharmaceutical form Cutaneous solution
    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 INNTerbinafine hydrochloride
    D.3.9.1CAS number 78628-80-5
    D.3.9.2Current sponsor codeMOB015B
    D.3.9.3Other descriptive nameTerbinafine hydrochloride
    D.3.9.4EV Substance CodeSUB04723MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Distal Subungual Onychomycosis
    Onicomicosi subungueale distale
    E.1.1.1Medical condition in easily understood language
    nail fungus
    Micosi dell'unghia
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine theefficacy of MOB015B in children based on assessment of treatment success, mycological cure, clinical cure, and complete cure.
    Esaminare l’efficacia di MOB015B nei bambini in base alla valutazione del successo del
    trattamento, della guarigione micologica, della guarigione clinica e della guarigione
    completa
    E.2.2Secondary objectives of the trial
    To evaluate local tolerability for all treated nails and adjacent skin as well as any other treatment-emergent adverse events (AEs).
    Valutare la tollerabilità locale per tutte le unghie trattate e la cute adiacente,
    nonché per qualsiasi altro evento avverso (EA) emergente dal trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be considered for enrollment in the study:
    1. Male or female subjects 6 to 17 yearsofage (inclusive).
    2. Distal subungual onychomycosis of at least oneof the great toenail(s) affecting at least 20% of the target nail to a maximum of 50% and at least 3 mm of unaffected proximal nail.
    3. Positive culture of dermatophyte and positive KOH microscopy in samples taken from the same great toenail.
    4. Signed written informed assent/consent.
    5. Evidence of ability of the great toenail to grow (eg,subject reports cutting toenails at least monthly).
    6. Able to comply with the study protocol (in the opinion of the investigator).
    Per essere considerati per l’arruolamento nello studio, i soggetti devono soddisfare
    tutti i seguenti criteri di inclusione:
    1. Soggetti di sesso maschile o femminile di età compresa tra 6 e 17 anni (inclusi).
    2. Onicomicosi subungueale distale di almeno uno degli alluci che interessa almeno il
    20% dell’unghia interessata fino a un massimo del 50% e almeno 3 mm di unghia prossimale
    non interessati.
    3. Coltura positiva di dermatofita e microscopia con KOH positiva in campioni prelevati
    dallo stesso alluce.
    4. Consenso/assenso informato scritto firmato.
    5. Evidenza della capacità di crescere dell’alluce (ad es., il soggetto riferisce di
    aver tagliato le unghie con cadenza almeno mensile).
    6. Capacità di attenersi al protocollo dello studio (secondo il parere dello
    sperimentatore).
    E.4Principal exclusion criteria
    Subjects meeting any of the following exclusion criteria will not be enrolled in the study:
    1. Proximal subungual onychomycosis, superficial white onychomycosis, significant dystrophy, severe onychorrhexis, or anatomic abnormalities of the great toenail(s) that in the opinion of the investigator would impair clinical evaluation of onychomycosis.
    2. Distal subungual onychomycosis where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 3 mm).
    3. Target toenail with greater than 50% disease involvement.
    4. Target toenail thickness more than 3 mm.
    5. “Spike” of onychomycosisextending to eponychium of the target nail.
    6. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
    7. Conditions other than distal subungual onychomycosis known to cause abnormal nail appearance, presence of melanonychia or subungual hematoma that could obscure visualization of nail clearing.
    8. Other microbial infections of the target toenail, for example, candida or mold infections without isolation of a dermatophyte
    9. Subjects with psoriasis, lichen planus, history of mucocutaneous candidiasis, or other conditions that affect nail appearance and/or growth.
    10. Previous target toenail surgery with any residual disfigurement.
    11. Topical treatment of the toenails with other antifungal medication within 4 weeks before screening/Visit 1.
    12. Use of systemic antifungal treatment within 6 months before screening/Visit 1.
    13. History or ongoing/active moderate to severe Moccasin tinea pedis.
    14. Having a diagnosis of type 1 diabetes or uncontrolled type 2 diabetes.
    15. Known immunodeficiency.
    16. Known human immunodeficiency virus (HIV)infection.
    17. Participation in another clinical study with an investigational drug or device during the previous 3 months before screening/Visit 1.
    18. Known allergy to any of the tested treatment products.
    19. A positive pregnancy test at enrollment/baseline (Visit 2).
    20. Female subjects physiologically capable of becoming pregnant but are unwilling to refrain from sexual intercourse during the whole study duration or unwilling to use acceptable methods of contraception as agreed with the investigator.
    21. Female subjects who are pregnant, breastfeedingmothers, those planning a pregnancy during the study or who become pregnant.
    I soggetti che soddisfano uno qualsiasi dei seguenti criteri di esclusione non saranno
    arruolati nello studio:
    1. Onicomicosi subungueale prossimale, onicomicosi bianca superficiale, distrofia
    significativa, onicorressi grave o anomalie anatomiche dell’alluce (o degli alluci) che,
    a giudizio dello sperimentatore, potrebbero compromettere la valutazione clinica
    dell’onicomicosi.
    2. Onicomicosi subungueale distale in cui il coinvolgimento si è esteso nella porzione
    prossimale dell’unghia interessata (la parte prossimale non colpita dell’unghia è
    inferiore a 3 mm).
    3. Unghia del piede interessata con coinvolgimento della malattia superiore al 50%.
    4. Spessore dell’unghia del piede interessata superiore a 3 mm.
    5. “Punta” di onicomicosi che si estende all’iponichio dell’unghia interessata.
    6. Presenza di dermatofitoma (definito come masse spesse di ife fungine e cheratina
    necrotica tra la lamina e il letto ungueale) sull’unghia interessata.
    7. Condizioni diverse dall’onicomicosi subungueale distale, che causano notoriamente un
    aspetto anomalo dell’unghia, presenza di melanonichia o ematoma subungueale che potrebbe
    oscurare la visualizzazione della schiaritura delle unghie.
    8. Onicomicosi causata da candida, muffa o altri non dermatofiti. Nel caso di una
    coltura mista (dermatofita e contaminante), la coltura pura del dermatofita viene
    identificata e segnalata come positiva.
    9. Soggetti con psoriasi, lichen planus, anamnesi di candidiasi mucocutanea o altre
    condizioni che influiscono sull’aspetto e/o sulla crescita dell’unghia.
    10. Pregresso intervento di chirurgia dell’unghia del piede interessata con eventuale
    deturpazione residua.
    11. Trattamento topico delle unghie dei piedi con altri farmaci antimicotici nelle 4
    settimane precedenti l’arruolamento/il basale.
    12. Uso di un trattamento antimicotico sistemico nei 6 mesi precedenti l’arruolamento/il
    basale.
    13. Anamnesi o tinea pedis “a mocassino” in corso/attiva.
    14. Diagnosi di diabete di tipo 1 o di diabete di tipo 2 non controllato.
    15. Immunodeficienza nota.
    16. Infezione nota da virus dell’immunodeficienza umana (HIV).
    17. Partecipazione a un altro studio clinico con un farmaco o dispositivo sperimentale
    nei 3 mesi precedenti l’arruolamento/il basale.
    18. Allergia nota a uno qualsiasi dei prodotti di trattamento testati.
    19. Test di gravidanza positivo allo screening o all’arruolamento/al basale (Visita 2).
    20. Soggetti di sesso femminile fisiologicamente in grado di rimanere incinte ma non
    disposti ad astenersi dai rapporti sessuali per l’intera durata dello studio o non
    disposti a utilizzare metodi contraccettivi accettabili come concordato con lo
    sperimentatore.
    21. Soggetti di sesso femminile in gravidanza, che allattano al seno, che pianificano
    una gravidanza durante lo studio o che rimangono incinte.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment success (defined as 0-10% clinical disease involvement of the target toenail and mycologicalcure of target toenail) at Week 48
    Successo del trattamento (definito come coinvolgimento clinico della malattia pari
    allo 0-10% dell’unghia del piede interessata e guarigione micologica dell’unghia del
    piede interessata) alla Settimana 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 48
    Settimana 48
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints at 48 weeks:
    - Clinical cure (defined as target toenail free of clinicaldiseaseinvolvement) at Week 48.
    - Complete cure (defined as negative fungal culture, negative direct potassium hydroxide [KOH] microscopy, and free of clinical disease involvement) of target toenail at Week 48.
    - Mycological cure (defined as negative fungal culture of dermatophytes and negative direct KOH microscopy) of target toenail at Week 48.

    Secondary safety endpoints:
    - Local tolerability of all treated toenails and surrounding skin at baseline and Weeks 4, 8, 12, 24, 36, and 48.
    - All adverse events (AEs) at baseline and Weeks 4, 8, 12, 24, 36, and 48.
    Endpoint secondari di efficacia a 48 settimane:
    • Guarigione clinica (definita come unghia del piede interessata priva di
    coinvolgimento clinicodella malattia) alla Settimana 48.
    • Guarigione completa (definita come coltura fungina negativa, microscopia diretta con
    idrossido di potassio [KOH] negativa e assenza di coinvolgimento clinico della
    malattia) dell’unghia del piede interessata alla Settimana 48.
    • Guarigione micologica (definita come coltura fungina negativa di dermatofiti e
    microscopia diretta con KOH negativa) dell’unghia del piede interessata alla Settimana
    48.
    Endpoint secondari di sicurezza:
    • Tollerabilità locale di tutte le unghie del piede trattate e della cute circostante
    al basale e alle Settimane 4, 8, 12, 24, 36 e 48.
    • Tutti gli eventi avversi (EA) al basale e alle Settimane 4, 8, 12, 24, 36 e 48.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: week 48
    Safety: weeks 4, 8, 12, 24, 36, and 48
    Efficacia: Settimana 48
    Sicurezza: Settimane 4, 8, 12, 24, 36, and 48
    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 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) 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 No
    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 EEA10
    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
    France
    Iceland
    Italy
    Poland
    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
    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 months9
    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 months9
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) No
    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 27
    F.4.2.2In the whole clinical trial 30
    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 Decision2023-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-19
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    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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