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    Summary
    EudraCT Number:2022-001251-16
    Sponsor's Protocol Code Number:M-14789-42
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-12-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-001251-16
    A.3Full title of the trial
    Open phase IV study to assess the impact of tirbanibulin on the well-being of patients with actinic keratoses (TIRBASKIN).
    Estudio abierto de fase IV para evaluar el impacto de tirbanibulina en el bienestar de los pacientes con queratosis actínica (TIRBASKIN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open phase IV study to assess the impact of tirbanibulin on the well-being of patients with actinic keratoses (TIRBASKIN).
    Estudio abierto de fase IV para evaluar el impacto de tirbanibulina en el bienestar de los pacientes con queratosis actínica (TIRBASKIN).
    A.3.2Name or abbreviated title of the trial where available
    Impacto de tirbanibulina en el bienestar de los pacientes con queratosis actínica
    A.4.1Sponsor's protocol code numberM-14789-42
    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 SponsorAlmirall, S.A.
    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 supportAlmirall S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOpis Spain S.L.
    B.5.2Functional name of contact pointGiovanni Trolese
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de Bruselas 15
    B.5.3.2Town/ cityAlcobendas
    B.5.3.3Post code28180
    B.5.3.4CountrySpain
    B.5.4Telephone number003491076 68 45
    B.5.6E-mailspain@opisresearch.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 Yes
    D.2.1.1.1Trade name Klisyri
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall Hermal GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameTirbanibulin
    D.3.2Product code M-14789-42
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Tirbanibulin is a new topical treatment for actinic keratosis (AK) of the face and scalp.
    La tirbanibulina es un nuevo tratamiento tópico para la queratosis actínica (QA) de la cara y el cuero cabelludo.
    E.1.1.1Medical condition in easily understood language
    Tirbanibulin is a new topical treatment for actinic keratosis (AK) of the face and scalp.
    La tirbanibulina es un nuevo tratamiento tópico para la queratosis actínica (QA) de la cara y el cuero cabelludo.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    Primary
    The primary objective is to assess treatment satisfaction on Day 57 in patients with AK of the face or scalp following treatment with tirbanibulin ointment 1% administered once daily for 5 consecutive days.
    Principales
    El objetivo principal es evaluar la satisfacción con el tratamiento en el día 57 en pacientes con QA de la cara o el cuero cabelludo tras el tratamiento con tirbanibulina en pomada al 1% administrada una vez al día durante 5 días consecutivos.
    E.2.2Secondary objectives of the trial
    Secondary
    The secondary objective is to evaluate patient-reported outcomes, physician-reported outcomes, efficacy, and safety following treatment with tirbanibulin ointment 1% administered once daily for 5 consecutive days.
    Secundarios
    El objetivo secundario es evaluar los resultados percibidos por los pacientes, los resultados comunicados por los médicos, la eficacia y la seguridad tras el tratamiento con tirbanibulina en pomada al 1% administrada una vez al día durante 5 días consecutivos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent.
    2. Males or females aged ≥18 years.
    3. Diagnosis of clinically typical AK in one contiguous area on the face or scalp with a treatment area of 25 cm2 containing 4‒8 AK lesions.
    4. Patients not previously treated for AK on the current treatment area of the face or scalp in the last 6 months. However, previous AK treatment in other small areas (up to 25cm2) in the last >1 to <6 months is allowed.
    5. Females must be postmenopausal (A female said to be postmenopausal should be >45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of child-bearing potential, must be using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive implant, injection or patch, intrauterine device, or complete abstinence from sexual intercourse.
    6. Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment.
    7. All subjects must agree not to donate sperm or eggs from screening through 90 days following their last dose of study treatment.
    8. Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0 prior to dose administration.
    9. Willing to avoid excessive sun or UV light exposure to the face or scalp.
    1. Consentimiento informado por escrito.
    2. Hombre o mujer, ≥18 años.
    3. Diagnóstico de QA clínicamente característica en una zona contigua de la cara o el cuero cabelludo con una zona de tratamiento de 25 cm2 que contenga entre 4 y 8 lesiones de QA.
    4. Pacientes que no hayan recibido tratamiento previo para la QA en la zona actual de la cara o el cuero cabelludo en los últimos 6 meses. Sin embargo, se permite el tratamiento previo de la QA en otras zonas pequeñas (hasta 25 cm2) en los últimos >1 a <6 meses.
    5. Las mujeres deben ser posmenopáusicas (se considera que una mujer es posmenopáusica si tiene más de 45 años y al menos 12 meses de amenorrea), estériles quirúrgicamente (por histerectomía, ovariectomía bilateral o ligadura de trompas) o, si están en edad fértil, deben utilizar métodos anticonceptivos altamente eficaces durante al menos 30 días o un ciclo menstrual, lo que sea más largo, antes del tratamiento del estudio y deben aceptar seguir utilizando métodos anticonceptivos altamente eficaces durante al menos 30 días después de la última dosis del tratamiento del estudio. La anticoncepción de alta eficacia incluye los anticonceptivos hormonales orales, el implante, inyección o parche anticonceptivo hormonal, el dispositivo intrauterino o la abstinencia completa de las relaciones sexuales.
    6. Los varones sexualmente activos que no se hayan sometido a una vasectomía, y cuya pareja sea fértil, deben aceptar utilizar métodos anticonceptivos de barrera desde la selección hasta 90 días después de la última dosis del tratamiento del estudio.
    7. Todos los participantes deben aceptar no donar esperma ni óvulos desde la selección hasta 90 días después de la última dosis del tratamiento del estudio.
    8. Las mujeres en edad fértil deben tener una prueba de embarazo negativa en suero en el momento de la selección y una prueba de embarazo negativa en orina el día 0 antes de la administración de la dosis.
    9. Estar dispuesto a evitar la exposición excesiva al sol o a los rayos UV en la cara o el cuero cabelludo.
    E.4Principal exclusion criteria
    1. Clinically atypical and/or rapidly changing AK lesions.
    2. Location of the treatment area is within 5 cm of an incompletely healed wound or a suspected basal cell carcinoma (BCC)/squamous cell carcinoma (SCC).
    3. Skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., open wounds, scarring) in the treatment area that might interfere with the study results or suppose anunacceptable risk. 4. History of sensitivity to any of the ingredients in the tirbanibulin formulation.
    5. Participated in a clinical trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing.
    6. Patients with a history of tirbanibulin treatment for AK lesions and patients who are currently on tirbanibulin treatment for AK lesions.
    7. Use of immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/ interferon inducers and systemic immunosuppressive agents (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab) within 4 weeks prior to the Screening visit, except for organ transplant recipients under stable immunosuppressive therapy for 6 months.
    8. Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit.
    9. Use of the following therapies and/or medications within 2 weeks prior to the Screening Visit:
    • Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area
    • Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area
    • Topical salves (nonmedicated/nonirritant lotion and cream are acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or within 5 cm of the selected treatment area
    10. Females who are pregnant or nursing.
    1. Lesiones de QA que no son clínicamente características o que cambian rápidamente.
    2. La ubicación de la zona de tratamiento está a menos de 5 cm de una herida que no se ha curado completamente o de un presunto carcinoma basocelular (CBC)/carcinoma epidermoide (CE).
    3. Enfermedad (p. ej., dermatitis atópica, psoriasis, eczema) o afección (p. ej., heridas abiertas, cicatrices) cutánea en la zona de tratamiento que puedan interferir con los resultados del estudio o presentar un riesgo inaceptable.
    4. Antecedentes de sensibilidad a cualquiera de los ingredientes de la formulación de tirbanibulina.
    5. Haber participado en un ensayo clínico durante el cual se administró un medicamento de estudio en investigación dentro de los 30 días o 5 semividas del producto en investigación, lo que sea más largo, antes de la dosis.
    6. Pacientes con antecedentes de tratamiento con tirbanibulina para lesiones de QA y pacientes que están actualmente en tratamiento con tirbanibulina para lesiones de QA.
    7. Uso de inmunomoduladores (p. ej., azatioprina), fármacos citotóxicos (p. ej., ciclofosfamida, vinblastina, clorambucil, metotrexato) o interferones/inductores de interferón y agentes inmunosupresores sistémicos (p. ej., ciclosporina, prednisona, metotrexato, alefacept, infliximab) dentro de las 4 semanas anteriores a la visita de selección, excepto en el caso de los receptores de trasplantes de órganos que hayan recibido un tratamiento inmunosupresor estable durante 6 meses.
    8. Uso de retinoides sistémicos (p. ej., isotretinoína, acitretina, bexaroteno) en los 6 meses anteriores a la visita de selección.
    9. Uso de los siguientes tratamientos o medicamentos dentro de las 2 semanas anteriores a la visita de selección:
    • Procedimientos cosméticos o terapéuticos (p. ej., uso de nitrógeno líquido, escisión quirúrgica, raspado, dermabrasión, exfoliación química de profundidad media o mayor, rejuvenecimiento con láser) dentro de la zona de tratamiento o a menos de 2 cm de la zona de tratamiento seleccionada
    • Productos terapéuticos que contienen ácido (p. ej., ácido salicílico o ácidos de frutas, como los ácidos alfa y beta-hidróxido y los ácidos glicólicos), retinoides tópicos o exfoliaciones químicas ligeras dentro de la zona de tratamiento
    • Bálsamos tópicos (se aceptan lociones y cremas no medicadas/no irritantes) o esteroides tópicos dentro de la zona de tratamiento o a menos de 2 cm de la zona de tratamiento seleccionada; bronceadores artificiales dentro de la zona de tratamiento o a menos de 5 cm de la zona de tratamiento seleccionada
    10. Mujeres embarazadas o en periodo de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    The primary trial endpoint is Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) score at Day 57.
    El criterio de valoración principal del ensayo es la puntuación del Cuestionario de satisfacción con el tratamiento del fármaco versión 9 (CSTF-9) en el día 57.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 57
    En el día 57
    E.5.2Secondary end point(s)
    Patient-Reported Outcomes:
    • Change from baseline in Skindex-16 at Day 57.
    • Organoleptic properties of tirbanibulin assessed on a Likert Scale at Day 8.
    • TSQM Version 1.4 (TSQM 1.4) at Day 57.
    • Patient treatment preference assessed through question 1 (Q1) to question 9 (Q9) of the Expert Panel Questionnaire (EPQ) at Day 57.
    Resultados percibidos por los pacientes:
    • Cambio desde el valor de referencia en el Skindex-16 en el día 57.
    Propiedades organolépticas de la tirbanibulina evaluadas en una escala de Likert en el día 8.
    • CSTF-9 versión 1.4 (CSTF 1.4) en el día 57.
    • La preferencia de tratamiento de los pacientes se evaluó mediante las preguntas 1 (P1) a 9 (P9) del Cuestionario del panel de expertos (CPE) en el día 57.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patient-Reported Outcomes: Day 57 with Questionnaire
    Paciente reporta resultados percibidos: day 57 con cuestionario
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    The objective is to assess treatment satisfaction on Day 57 in patients with AK of the face or scalp following treatment with tirbanibulin ointment 1% administered once daily for 5 consecutive days.
    El objetivo es evaluar la satisfacción con el tratamiento en el día 57 en pacientes con QA de la cara o el cuero cabelludo tras el tratamiento con tirbanibulina en pomada al 1% administrada una vez al día durante 5 días consecutivos.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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
    last visit of the last subject
    Ultima visita del ultimo 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 years0
    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 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: 400
    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 Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state420
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 420
    F.4.2.2In the whole clinical trial 420
    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
    No
    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 Decision2022-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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