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    Summary
    EudraCT Number:2016-003784-19
    Sponsor's Protocol Code Number:RJ-CPX01
    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:2017-04-18
    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 number2016-003784-19
    A.3Full title of the trial
    Phase III, multicentre, randomised, double blind, parallel-group, clinical trial
    to evaluate the efficacy and safety of a new medicated nail lacquer for the treatment
    of toenail fungal infection
    Ensayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, de grupos paralelos, para evaluar la eficacia y seguridad de un nuevo barniz de uñas medicamentoso para el tratamiento de la infección fúngica en las uñas del pie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study with a medicated nail lacquer for the treatment of toenail fungal infection
    Un estudio con un barniz de uñas medicamentoso para el tratamiento de la infección fúngica en las uñas del pie
    A.4.1Sponsor's protocol code numberRJ-CPX01
    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 SponsorLaboratorio Reig Jofre, SA
    B.1.3.4CountrySpain
    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 supportLaboratorio Reig Jofre, SA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorio Reig Jofre, SA
    B.5.2Functional name of contact pointClinical R&D
    B.5.3 Address:
    B.5.3.1Street AddressC/ Gran Capità, 10
    B.5.3.2Town/ citySant Joan Despí, Barcelona
    B.5.3.3Post code08970
    B.5.3.4CountrySpain
    B.5.4Telephone number0034658271136
    B.5.6E-mailJordi.Picas@reigjofre.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRJ-0265
    D.3.2Product code RJ-0265
    D.3.4Pharmaceutical form Cutaneous liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Conjunctival use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCICLOPIROX
    D.3.9.1CAS number 29342-05-0
    D.3.9.2Current sponsor codeRJ-0265
    D.3.9.4EV Substance CodeSUB06245MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Ony-Tec
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios MEDEA, S.A
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameOny-Tec
    D.3.4Pharmaceutical form Cutaneous liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCICLOPIROX
    D.3.9.1CAS number 29342-05-0
    D.3.9.4EV Substance CodeSUB06245MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 placeboCutaneous liquid
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    toenail onychomycosis
    onicomicosis de la uña del dedo del pie
    E.1.1.1Medical condition in easily understood language
    toenail fungal infection
    infección por hongos de la uña del pie
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10030338
    E.1.2Term Onychomycosis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of RJ-0265, in terms of complete cure, compared to placebo, for the treatment of toenail onychomycosis due to dermatophyte fungi.
    Evaluar la eficacia del RJ-0265, en términos de curación completa en comparación con placebo, para el tratamiento de la onicomicosis en las uñas del pie debida a hongos dermatófitos
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of RJ-0265, in terms of clinical success, responder and improvement, in comparison with placebo at week 52.
    - To evaluate the efficacy of RJ-0265, in terms of complete cure, in comparison with the marketed reference ciclopirox nail lacquer at week 52.
    -To evaluate the efficacy of RJ-0265, in terms of clinical success, responder and improvement, compared to marketed reference ciclopirox nail lacquer at week 52.
    -To assess the growth rate of healthy nail, at week 52.
    -To assess the time (months) to complete cure or clinical success, at week 52.
    -To assess all efficacy endpoints at week 48 (end of treatment).
    -To evaluate the efficacy of RJ-0265, in terms of complete cure, Clinical success and Responders in comparison with placebo at week 52 depending on the baseline degree of involvement

    Overall safety of 48 weeks of treatment and follow-up
    -Evaluar eficacia de RJ-0265, en términos de éxito médico, sujetos que responden al tratamiento y mejora en comparación con placebo en semana 52
    -Evaluar eficacia de RJ-0265, en términos de curación completa, en comparación con el barniz de uñas con ciclopirox comercializado de referencia en semana 52.
    -Evaluar la eficacia de RJ-0265, en términos de éxito médico, sujetos que responden al tratamiento y mejora en comparación con el barniz de uñas con ciclopirox comercializado de referencia en semana 52.
    -Evaluar tasa de crecimiento de uña sana en semana 52.
    -Determinar el tiempo hasta la curación completa o éxito médico, en semana 52.
    -Evaluar criterios de valoración de la eficacia en semana 48 (findel tratamiento).
    -Evaluar eficacia de RJ-0265, en términos de completa cura, de éxito médico, de sujetos que responden según evaluación realizada por una entidad independiente la semana 52 (comparación RJ-0265 y placebo) dependiendo del grado basal de implicación

    Seguridad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent before starting any study related procedures.
    2. Adult men and women aged 18 to 70 years with distal mild to moderate onychomycosis due
    to dermatophyte fungi (i.e. involving > or = 20% to < or = 60% of the distal bed adherent nail plate,
    without involvement of the lunula) affecting at least one big toenail.
    3. Disease proven by culture at screening (positivity confirmed before randomization).
    4. Positive KOH preparation at screening (positivity confirmed before randomization).
    1. Firma un consentimiento informado antes de iniciar cualquiera de los procedimientos relacionados con el estudio.
    2. Es un hombre o mujer adulto de entre 18 y 70 años de edad (ambos inclusive) con onicomicosis distal leve o moderada debida a hongos dermatófitos (esto es, con afectación > o = 20 % y < o = 60 % de la lámina ungueal distal adherida del lecho, sin afectación de la lúnula) y que afecta al menos a una uña del dedo gordo del pie.
    3. Afección constatada mediante cultivo en el momento de la selección (positividad confirmada antes de la aleatorización).
    4. Preparación KOH positiva en el momento de la selección (positividad confirmada antes de la aleatorización).
    E.4Principal exclusion criteria
    1. Allergy to ciclopirox or to any component of the study medication.
    2. Life expectancy less than 2 years at screening.
    3. Regular use of cosmetic lacquer on the toenails, unwilling to interrupt.
    4. Pregnancy or breast-feeding.
    5. Woman of child bearing potential who does not use any reliable contraception.
    6. Systemic antifungal drugs in the 6 months prior to screening, or need for same.
    7. Topical antifungal drugs in the four weeks prior to screening visit.
    8. Chemotherapy in the 12 weeks prior to screening or need for same.
    9. Immunosuppressive therapy in the 12 weeks prior to screening or need for same.
    10. Systemic glucocorticosteroids in the 4 weeks prior to screening or need for same.
    11. Systemic antimetabolites in the 4 weeks prior to screening or need for same.
    12. Systemic immunostimulants in the 4 weeks prior to screening or need for same.
    13. Evidence of psoriasis.
    14. Uncontrolled diabetes mellitus (irrespective IDDM, NIDDM).
    15. Suspicion or evidence of severe liver or kidney disease.
    16. Alcohol or substance abuse.
    17. AIDS or any other immunodeficiency.
    18. Onychomycosis caused by yeasts or non-dermatophytes moulds.
    19. Mucocutaneous candidiasis.
    20. White superficial onychomycosis.
    21. Proximal subungual involvement (marker of immunosuppressed patient).
    22. “Yellow spikes” on nail (extension of fungal infection from distal to proximal part of nail).
    23. Patients with recurrent erysipela at the screening (if erysipela infection occur during the study,
    the patient will be allowed to continue the study and to be treated with antibiotic (penicillin)).
    24. Any other medical condition which, in the investigator’s opinion, contraindicates the subject’s
    participation in the trial.
    25. Forecast of little cooperation, non-compliance of medical treatment or little credibility.
    26. Has participated in any clinical investigation with medicine within the last 6 months prior to
    screening visit.
    1. Alergia al ciclopirox o a cualquiera de los componentes de la medicación del estudio.
    2. Esperanza de vida menor de 2 años en el momento de la selección.
    3. Uso habitual de barniz cosmético en las uñas de los pies y falta de disposición para interrumpir este uso.
    4. Embarazo o en periodo de lactancia.
    5. Mujer con posibilidad de quedar embarazada que no utilice ningún método anticonceptivo fiable.
    6. Uso de fungicidas sistémicos en los 6 meses anteriores a la selección, o necesidad de los mismos.
    7. Uso de fungicidas tópicos en las 4 semanas anteriores a la visita de selección.
    8. Quimioterapia en las 12 semanas anteriores a la selección, o necesidad de la misma.
    9. Tratamiento inmunodepresor en las 12 semanas anteriores a la selección, o necesidad del mismo.
    10. Glucocorticoesteroides sistémicos en las 4 semanas anteriores a la selección, o necesidad de los mismos.
    11. Antimetabolitos sistémicos en las 4 semanas anteriores a la selección, o necesidad de los mismos.
    12. Inmunoestimulantes sistémicos en las 4 semanas anteriores a la selección, o necesidad de los mismos.
    13. Indicios de psoriasis.
    14. Diabetes no controlada (independientemente de si es DDI, o DII).
    15. Sospecha o indicios de hepatopatía o nefropatía grave.
    16. Alcoholismo o toxicomanía.
    17. SIDA o cualquier otra inmunodeficiencia.
    18. Onicomicosis causada por hongos levaduriformes u hongos no dermatófitos.
    19. Candidiasis mucocutánea.
    20. Onicomicosis superficial blanca.
    21. Afectación subungueal proximal (marcador de paciente inmunodeprimido).
    22. «Puntas amarillas» en la uña (extensión de la micosis desde la parte distal a la proximal de la uña).
    23. Pacientes con erisipela recurrente en el momento de la selección (si la infección por erisipela se produce durante el estudio, se permitirá al paciente continuar en el estudio y se tratará con antibióticos (penicilina)).
    24. Cualquier otra afección médica que, en opinión del investigador, desaconseje la participación del sujeto en el ensayo.
    25. Previsión de poca cooperación, incumplimiento terapéutico o escasa credibilidad.
    26. Haber participado en alguna investigación clínica con medicación en los últimos 6 meses anteriores a la visita de selección.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of complete cure, assessed by an independent evaluator, at week 52 (comparison between RJ-0265 and placebo).
    Tasa de curación completa evaluada por una entidad independiente en la semana 52 (comparación entre RJ-0265 y placebo)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 52
    En la semana 52
    E.5.2Secondary end point(s)
    - Rate of clinical success as assessed by the independent evaluator at week 52 (comparison between RJ-0265 and placebo)
    - Rate of responders as assessed by the independent evaluator at week 52 (comparison between RJ-0265 and placebo).
    - Rate of improvement, as assessed by the independent evaluator, at the end of treatment versus baseline and conversion to negative KOH and culture (comparison between RJ-0265 and placebo).
    - Decrease of diseased nail area to ≤10% of total, as assessed by the independent evaluator at week 52 (comparison between RJ-0265 and placebo).
    - Conversion to negative of culture at week 52 (comparison between RJ-0265 and placebo).
    - Conversion to negative of microscopy findings on KOH examination at week 52 (comparison between RJ-0265 and placebo).
    - Preliminary assessment of clinical cure, clinical success and responder rate by investigators at week 52.
    - Growth rate of healthy nail, at week 52.
    - Diseased nail area by computer planimetry evaluation, after confirmation of independent evaluator (comparison between RJ-0265 and placebo).
    - Time (months) to complete cure or clinical success as assessed by the independent evaluator and by the investigator.
    - Rate of complete cure, clinical success and Responders as assessed by the independent evaluator at week 52 (comparison between RJ-0265 and placebo) depending on the baseline degree of involvement (e.g. <30%, <50%, etc.)
    - Tasa de éxito médico según la evaluación realizada por una entidad independiente en la semana 52 (comparación entre RJ-0265 y placebo).
    - Tasa de sujetos que responden al tratamiento según la evaluación realizada por una entidad independiente en la semana 52 (comparación entre RJ-0265 y placebo).
    - Tasa de mejora, según la evaluación realizada por una entidad independiente al final del tratamiento frente al estado inicial, y conversión a KOH y cultivo negativo (comparación entre RJ-0265 y placebo).
    - Reducción del área de la uña afectada hasta ≤ 10 % del total, según la evaluación realizada por una entidad independiente en la semana 52 (comparación entre RJ-0265 y placebo).
    - Conversión a negativo del cultivo en la semana 52 (comparación entre RJ-0265 y placebo).
    - Conversión a negativo de los hallazgos del examen microscópico con KOH en la semana 52 (comparación entre RJ-0265 y placebo).
    - Evaluación preliminar de la tasa de curación, éxito médico y sujetos que responden al tratamiento por parte de los investigadores en la semana 52.
    - Tasa de crecimiento de la uña sana, en la semana 52.
    - Área de uña afectada mediante evaluación planimétrica computarizada, tras la confirmación realizada por una entidad independiente (comparación entre RJ-0265 y placebo).
    - Tiempo (meses) hasta la curación completa o éxito médico, según lo evaluado por una entidad independiente y por el investigador.
    - Tasa de completa cura, de éxito médico, de sujetos que responden según la evaluación realizada por una entidad independiente en la semana 52 (comparación entre RJ-0265 y placebo) Dependiendo del grado basal de implicación (por ejemplo <30%, <50%, etc.)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 52
    En la semana 52
    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) 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 No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Latvia
    Mexico
    Spain
    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
    LSLV
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    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 months1
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 255
    F.4.2.2In the whole clinical trial 360
    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
    Ninguno
    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 Decision2017-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-16
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