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    Summary
    EudraCT Number:2019-001084-71
    Sponsor's Protocol Code Number:B7981032
    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:2020-03-12
    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 number2019-001084-71
    A.3Full title of the trial
    A PHASE 3 OPEN LABEL, MULTI CENTER, LONG TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA
    ESTUDIO DE FASE III, ABIERTO, MULTICÉNTRICO, A LARGO PLAZO, PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE PF-06651600 EN PARTICIPANTES ADULTOS Y ADOLESCENTES CON ALOPECIA AREATA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-Term PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-LT)
    PF-06651600 a largo plazo para el tratamiento de alopecia areata (ALLEGRO-LT)
    A.3.2Name or abbreviated title of the trial where available
    Study Evaluating PF-06651600 in Adults and Adolescents with Alopecia Areata
    Estudio para evaluar PF-06651600 en adultos y adolescentes con alopecia areata
    A.4.1Sponsor's protocol code numberB7981032
    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 SponsorPfizer Inc. 235 East 42nd Street, New York, New York
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34914909900
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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.3.2Product code PF-06651600
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number Not availabl
    D.3.9.2Current sponsor codePF-06651600
    D.3.9.3Other descriptive nameJanus Kinase 3 inhibitor
    D.3.9.4EV Substance CodeSUB174316
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Alopecia areata
    Alopecia areata
    E.1.1.1Medical condition in easily understood language
    Scalp Hair Loss
    Pérdida de cabello en el cuero cabelludo
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10001761
    E.1.2Term Alopecia areata
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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 long term safety and tolerability of PF-06651600 in adult and adolescent participants with AA in the treatment period over time.
    Evaluar la seguridad y la tolerabilidad a largo plazo de PF-06651600 en adultos y adolescentes participantes con AA en el periodo de tratamiento a lo largo del tiempo.
    E.2.2Secondary objectives of the trial
    To evaluate the long term efficacy of PF-6651600 in adult and adolescent participants with AA.
    Evaluar la eficacia a largo plazo de PF-06651600 en adultos y adolescentes participantes con AA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for De Novo Participants and Those Originating from B7931005 or B7981015 with >30 Days between the Index Study and Study B7981032
    1.Participants must meet the following AA criteria:
    •Have a clinical diagnosis of AA with no other etiology of hair loss (including, but not limited to traction and scarring alopecia, telogen effluvium). Androgenetic alopecia coexistent with AA is allowed provided that the following criteria are met;
    • >=25% scalp hair loss due to AA (including AT and AU), as measured by SALT, at both the screening and Day 1 visits which, in the opinion of the investigator, is appropriate for systemic therapy;
    •For male de novo participants with known androgenetic alopecia, in the assessment of the investigator, the participant’s prior or current Hamilton Norwood Grade must be <IV (Appendix 17). Hair loss must be carefully reviewed to verify that >=25% scalp hair loss is due to AA (ie, SALT (AA) score is >=25%). If, in cases of concomitant AA and androgenetic alopecia, it cannot be verified that SALT (AA) score is >=25%, then the participant must be excluded from the study.
    •No evidence of terminal scalp hair regrowth within 6 months of both the screening and Day 1 visits (for de novo participants only);
    •Current episode of hair loss due to AA =<10 years (for de novo participants only);
    •Photographs of the scalp taken at screening must be submitted to the designated independent consultant for verification that the percentage of scalp hair loss due to AA meets the study entry criteria.
    Inclusion Criteria for All Participants Originating from B7931005 or B7981015
    2.Participants enrolling from Study B7931005 must have:
    •Taken the last dose of PF 06700841 (a TYK2/JAK1 inhibitor) in Study B7931005 >12 weeks prior to the Study B7981032 Day 1 visit.
    3.Participants enrolling from Study B7981015 must have:
    •Completed >=34 weeks of study intervention.
    Inclusion Criteria for All Participants
    4.All participants must be >=12 years of age, at the time they or their parent or guardian signs the informed consent. Participants below the age of 18 years will only be enrolled into this study if permitted by the sponsor, local competent authority, and institutional review board (IRB)/ethics committee (EC). Otherwise, only participants 18 years or older (or age by applicable reviewer) will be enrolled in those countries, regions or sites.Within the EU, subjects must be aged 18 through 74 years at the time of informed consent.
    5.Male or Female
    For all participants contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    a.Male participants:
    No contraceptive measures required.
    b.Female participants:
    •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    •Is not a woman of childbearing potential (WOCBP), See Appendix 4.
    •OR
    •Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Appendix 4 during the intervention period and for at least 28 days after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
    •A WOCBP must have a negative highly sensitive (Appendix 2) pregnancy test (urine or serum as required by local regulations) at the Day 1 visit before the first dose of study intervention.
    •If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
    •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
    6.All participants must be capable of giving signed informed consent/assent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    7.All participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    8.If receiving permitted concomitant medications for any reason other than AA, participants should be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half lives (whichever is longer) prior to Day 1. Participants must be willing to stay on a stable regimen during the duration of the study (see Section 6.5).
    9.All participants must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
    Criterios de inclusión para los participantes nuevos y procedentes de los estudios B7931005 o B7981015 con >30 días entre el estudio inicial y el estudio B7981032
    1. Los participantes deben cumplir los siguientes criterios de AA:
    •Tener un diagnóstico clínico de AA sin ninguna otra etiología para la pérdida del pelo (como, por ejemplo, tracción y alopecia cicatricial, efluvio telógeno). Se permite la coexistencia de alopecia androgénica con la AA siempre que se cumplan los criterios siguientes;
    • >=25 % de pérdida de pelo en el cuero cabelludo debida a AA (incluyendo alopecia totalis [AT] y alopecia universalis [AU]), medida según SALT, tanto en la selección como en las visitas del día 1 que, en opinión del investigador, sea adecuada para un tratamiento sistémico;
    •En los participantes masculinos nuevos con alopecia androgénica conocida, según la evaluación del investigador, el grado de Hamilton-Norwood previo o actual del participante debe ser <IV (apéndice 17). Debe examinarse cuidadosamente la caída del cabello para verificar que la pérdida de pelo del cuero cabelludo >=25 % se deba a AA (es decir, que la puntuación en SALT [para AA] sea >=25 %). Si, en los casos de AA concomitante y alopecia androgénica, no se puede verificar que la puntuación en SALT (para AA) es >=25 %, se deberá excluir al participante del estudio.
    •Ningún indicio de crecimiento de pelo terminal nuevo en el cuero cabelludo en las zonas afectadas por AA dentro de los 6 meses anteriores a las visitas de selección y del día 1 (para los participantes nuevos solamente);
    •Episodio actual de pérdida de pelo por AA =<10 años (para los participantes nuevos solamente);
    •Las fotografías del cuero cabelludo tomadas en la selección se deben enviar al asesor independiente designado para verificar que el porcentaje de pérdida de pelo en el cuero cabelludo debido a AA cumple los criterios de inclusión en el estudio.
    Criterios de inclusión para todos los participantes procedentes de los estudios B7931005 o B7981015
    2. Los participantes inscritos procedentes del estudio B7931005 deben haber:
    •Tomado la última dosis de PF-06700841 (un inhibidor de TYK2/JAK1) en el estudio B7931005 >12 semanas antes de la visita del día 1 del estudio B7981032.
    3. Los participantes inscritos procedentes del estudio B7981015 deben haber:
    •Terminado >=34 semanas de la intervención del estudio.
    Criterios de inclusión para todos los participantes
    4. Todos los participantes deben tener >=12 años de edad en el momento en que ellos o su progenitor o tutor firmen el consentimiento informado. Los participantes menores de 18 años solo se inscribirán en este estudio si lo permiten el promotor, la autoridad competente local y el comité de ética (CE). De lo contrario, en esos países, regiones o centros solo se inscribirán participantes de 18 años de edad en adelante (o la edad que establezca el revisor pertinente). Dentro de los países del procedimiento voluntario de armonización (VHP) de la UE, los participantes nuevos deben tener entre 18 y 74 años en el momento del consentimiento informado.
    5. Hombre o mujer
    En todos los participantes, el uso de anticonceptivos por parte de los hombres o de las mujeres debe cumplir la reglamentación local con respecto a métodos anticonceptivos para participantes en estudios clínicos.
    a. Participantes de sexo masculino:
    No se requieren medidas anticonceptivas.
    b. Participantes de sexo femenino:
    •Las mujeres podrán participar si no están embarazadas ni amamantando y si se cumple al menos una de las condiciones siguientes:
    •No es una mujer con capacidad de concebir (MCC); véase el apéndice 4.
    •O
    •Es una MCC y usa un método anticonceptivo muy eficaz con una tasa de fracasos <1 % según lo descrito en el apéndice 4, durante el período de la intervención y durante al menos 28 días después de la última dosis de la intervención del estudio. El investigador debe evaluar la eficacia del método anticonceptivo en relación con la primera dosis de la intervención del estudio.
    •Las MCC deben presentar un resultado negativo en una prueba de embarazo de alta sensibilidad (apéndice 2) (orina o suero, según lo exigido por la
    reglamentación local) en la visita del día 1 antes de la primera dosis de la intervención del estudio.
    •Si no se puede confirmar si una prueba en orina es negativa (p. ej., un resultado ambiguo), será preciso realizar una prueba de embarazo en suero. En tales casos, debe excluirse de intervenir a esa participante si el resultado de la prueba de embarazo en suero es positivo.
    •El investigador será el responsable de revisar el historial médico, los antecedentes menstruales y la actividad sexual reciente para reducir el riesgo de inclusión de una mujer con un embarazo incipiente no detectado.
    6. Todos los participantes deben ser capaces de otorgar su asentimiento/consentimiento [….]
    Para el resto de criterios de inclusión por favor refieranse al protocolo del estudio.
    E.4Principal exclusion criteria
    Exclusion Criteria for Participants Originating from B7931005 or B7981015 with <=30 Days between Studies
    1.During Study B7931005 or B7981015 or in the period between the index study and Study B7981032, presence of events meeting criteria in the Discontinuation section of Appendix 8 (eg, serious infections, laboratory results, ECG results).
    2.Discontinuation from Study B7931005 or B7981015 for safety related events. Participants discontinued from Study B7931005 or B7981015 due to issues other than safety-related events must be discussed with the sponsor prior to enrollment in Study B7981032.
    Exclusion Criteria for De Novo Participants and Those Originating from B7931005 or B7981015 with >30 Days between the Index Study and Study B7981032
    3.Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc).
    4.Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).
    5.Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria:
    a.Suicidal ideation associated with actual intent and a method or plan in the past year: “Yes” answers on items 4 or 5 of the Columbia Suicide Severity Rating Scale (C SSRS) (Section 8.2.9).
    b.For participants who had previous history of suicidal behaviors in the past >1 year to <5 years: “Yes” answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C SSRS or any lifetime history of serious or recurrent suicidal behavior, a risk assessment must be performed, and documented, by a qualified mental health professional to assess whether it is safe for the participant to participate in the trial.
    c.The presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria.
    d.Clinically significant depression as indicated by a Patient Health Questionnaire 8 Items (PHQ 8) total score >=15 (Section 8.2.10).
    NOTE: For any participant who has significant depression or any suicidal behavior, the participant will not be assigned to study intervention and should be referred for appropriate evaluation and treatment.
    6.Have hearing loss with progression over the previous 5 years, or sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere’s disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating or progressive.
    •Participants originating from Study B7931005 or B7981015 with occurrences of any of the above either during the index study or between the end of the index study and Study B7981032 can only be enrolled in Study B7981032 with prior approval of the sponsor.
    Exclusion Criteria for All Participants
    7.Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.
    8.Participation in studies other than B7931005 or B7981015 involving investigational drug(s) within 8 weeks (12 weeks for JAK inhibitors other than PF 06651600 received in Study B7931005 or B7981015) or within 5 half lives (if known), whichever is longer, prior to study entry and/or during study participation.
    Please see the Protocol for a complete list of exclusion criteria.
    Criterios de exclusión para los participantes procedentes del estudio B7981015 con <=30 días entre estudios
    1.Durante el estudio B7981015, o en el periodo entre el estudio inicial y el estudio B7981032, presencia de acontecimientos que cumplan los criterios de la sección Interrupción del apéndice 8 (p. ej., infecciones graves, resultados analíticos, resultados de ECG).
    2. Interrupción del estudio B7981015 por acontecimientos relacionados con la seguridad. Los casos de los participantes que hayan interrumpido el estudio B7981015 debido a problemas que no sean acontecimientos relacionados con la seguridad se deben comentar con el Promotor antes de su inscripción en el estudio B7981032.
    Criterios de exclusión para los participantes nuevos y procedentes de los estudios B7931005 o B7981015 con >30 días entre el estudio inicial y el estudio B7981032
    3.Otra enfermedad del cuero cabelludo que pueda afectar a la evaluación de la AA (p. ej., psoriasis en el cuero cabelludo, dermatitis, etc.).
    4. Enfermedades sistémicas activas que puedan causar pérdida de cabello (p. ej., lupus eritematoso, tiroiditis, esclerosis sistémica, liquen plano, etc.).
    5. Cualquier trastorno psiquiátrico, incluidas las ideas de suicidio recientes o activas, o los comportamientos que cumplan alguno de los criterios siguientes:
    a. Ideas de suicidio asociadas a intento real y un método o plan durante el año anterior: Respuestas de “Sí” en los ítems 4 o 5 de la Escala de Columbia para Evaluar la Gravedad del Riesgo de Suicidio (C-SSRS) (sección 8.2.9).
    b.Para los participantes que hayan tenido antecedentes de comportamiento suicida hace >1 año y <5 años: En caso de que hayan respondido “Sí” (a episodios producidos en los 5 años anteriores) a alguno de los ítems de conductas suicidas de la C-SSRS o de antecedentes de comportamiento suicida grave o recurrente en algún momento de la vida, debe llevarse a cabo y documentarse una evaluación de riesgos a cargo de un profesional de la salud mental cualificado para evaluar si es seguro para esa persona participar en el ensayo.
    c. La presencia de cualquier trastorno psiquiátrico importante en activo que no esté permitido explícitamente en los criterios de inclusión/exclusión.
    d. Depresión clínicamente significativa según una puntuación total >=15 en los ítems del Cuestionario de salud del paciente de 8 ítems (PHQ-8) (sección 8.2.10).
    NOTA: A cualquier participante que presente depresión significativa o cualquier conducta suicida se le excluirá de la intervención del estudio y se le derivará para recibir una evaluación y tratamiento adecuados.
    6.Haber tenido hipoacusia con progresión durante los 5 años anteriores o hipoacusia repentina, o alguna enfermedad del oído medio o interno, como otitis media, colesteatoma, enfermedad de Ménière, laberintitis u otro trastorno auditivo que se considere agudo, fluctuante o progresivo.
    •Los participantes procedentes de los estudios B7931005 o B7981015 que hayan presentado cualquiera de lo anterior durante el estudio inicial o entre el final del estudio inicial y el estudio B7981032, solo se podrán inscribir en el estudio B7981032 con la aprobación previa del promotor.
    Criterios de exclusión para todos los participantes
    7.Empleados del centro del investigador implicados directamente en la realización del estudio y sus familiares, empleados del centro supervisados de alguna otra manera por el investigador o participantes que sean empleados de Pfizer, incluidos sus familiares, directamente implicados en la realización del estudio.
    8.La participación en estudios aparte de B7931005 o B7981015 con fármacos experimentales dentro de las 8 semanas (12 semanas para los inhibidores de la JAK distintos del PF-06651600 recibido en los estudios B7931005 o B7981015) o de las 5 semividas (si se conocen) –lo que suponga más tiempo– anteriores a la entrada en el estudio o durante la participación en este.
    Por favor refieranse al protocolo para listado completo de criterios de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    •Incidence of treatment emergent adverse events (TEAEs);
    •Incidence of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation;
    •Incidence of clinically significant abnormalities in vital signs;
    •Incidence of clinically significant abnormalities in clinical laboratory values.
    •Incidencia de acontecimientos adversos surgidos durante el tratamiento (AAST);
    •Incidencia de acontecimientos adversos graves (AcAG) y de acontecimientos adversos (AcA) que provoquen la interrupción del tratamiento;
    •Incidencia de anomalías clínicamente significativas en los signos vitales;
    •Incidencia de anomalías clínicamente significativas en los valores analíticos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ongoing evaluation at intermittent timepoints until Day 720/EOT
    Evaluación continua en puntos temporales intermitentes hasta el dia 720/FDT
    E.5.2Secondary end point(s)
    •Response based on achieving absolute Severity of Alopecia Tool (SALT) score ≤10 at all time points collected, for overall and AA SALT score;
    •Absolute SALT scores at all time points collected, for overall and AA SALT score;
    •Response based on achieving at least 50% improvement in SALT (SALT50) from baseline at all time points collected, for overall and AA SALT score;
    •Response based on achieving at least 75%, improvement in SALT (SALT75) from baseline at all time points collected, for overall and AA SALT score;
    •Response based on achieving at least 90% improvement in SALT (SALT90) from baseline at all time points collected, for overall and AA SALT score;
    •Response based on achieving at least a 2 grade improvement from baseline or a score of 3 in Eyebrow Assessment (EBA) score at all time points collected;
    •Response based on achieving at a least 2 grade improvement from baseline or a score of 3 in Eyelash Assessment (ELA) score at all time points collected.
    •Respuesta basada en la consecución de una puntuación absoluta en el Severity of Alopecia Tool [Instrumento para la gravedad de la alopecia, SALT] ≤10 en los puntos temporales en que se mida, en la puntuación general y en la de SALT para AA;
    •Puntuaciones absolutas de SALT en todos los puntos temporales en que se mida, en la puntuación general y en la de SALT para AA;
    •Respuesta basada en la consecución de una mejoría al menos del 50 % en SALT (SALT50) con respecto al inicio en todos los puntos temporales en que
    se mida, en la puntuación general y en la de SALT para AA;
    •Respuesta basada en la consecución de una mejoría al menos del 75 % en SALT (SALT75) con respecto al inicio en todos los puntos temporales en que
    se mida, en la puntuación general y en la de SALT para AA;
    •Respuesta basada en la consecución de una mejoría al menos del 90 % en SALT (SALT90) con respecto al inicio en todos los puntos temporales en que
    se mida, en la puntuación general y en la de SALT para AA;
    •Respuesta basada en la consecución de una mejoría al menos de 2 grados con respecto al inicio o de una puntuación de 3 en la Eyebrow Assessment
    [Evaluación de las cejas, EBA] en todos los puntos temporales en que se mida;
    •Respuesta basada en la consecución de una mejoría al menos de 2 grados con respecto al inicio o de una puntuación de 3 en la Eyelash Assessment
    [Evaluación de las pestañas, ELA] en todos los puntos temporales en que se mida.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the Month 24 or Early Termination visit
    En el mes 24 o visita de finalización anticipada
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Argentina
    Australia
    Canada
    Chile
    China
    Colombia
    Czech Republic
    Germany
    Hungary
    Japan
    Korea, Republic of
    Mexico
    Poland
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    E.8.9.2In all countries concerned by the trial months11
    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: 99
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 99
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 545
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 129
    F.4.2.2In the whole clinical trial 860
    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)
    There is no intervention required by the protocol following the end of the study
    No es necesaria ninguna intervención por protocolo después del final del estudio
    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 Decision2020-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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