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    Summary
    EudraCT Number:2021-002365-18
    Sponsor's Protocol Code Number:CP543.5002
    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:2021-10-26
    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 number2021-002365-18
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CTP-543 IN ADULT PATIENTS WITH MODERATE TO SEVERE ALOPECIA AREATA
    ESTUDIO DE EXTENSIÓN ABIERTO, MULTICÉNTRICO, PARA EVALUAR LA EFICACIA Y SEGURIDAD A LARGO PLAZO DE CTP-543 EN PACIENTES ADULTOS CON ALOPECIA AREATA DE MODERADA A GRAVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the long-term efficacy and safety following administration of CTP-543 in adult patients with moderate to severe alopecia areata
    Estudio para evaluar la eficacia y seguridad a largo plazo tras la administración de CTP-543 en pacientes adultos con alopecia areata de moderada a grave
    A.4.1Sponsor's protocol code numberCP543.5002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05041803
    A.5.4Other Identifiers
    Name:INDNumber:131,423
    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 SponsorConcert Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportConcert Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLinical France SARL
    B.5.2Functional name of contact pointMedical Manager
    B.5.3 Address:
    B.5.3.1Street Address52 Take Ionescu Boulevard
    B.5.3.2Town/ cityTimisoara
    B.5.3.3Post code300073
    B.5.3.4CountryRomania
    B.5.4Telephone number+40256207271
    B.5.5Fax number+40256207273
    B.5.6E-maildiana.chera@linical.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 namedeuruxolitinib (Tablet 8 mg every 12 hours)
    D.3.2Product code CTP-543
    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 INNdeuruxolitinib phosphate
    D.3.9.1CAS number 2147706-60-1
    D.3.9.2Current sponsor codeCTP-543 phosphate
    D.3.9.3Other descriptive nameC-21543; D8-RUXOLITINIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 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 namedeuruxolitinib (Tablet 12 mg every 12 hours)
    D.3.2Product code CTP-543
    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 INNdeuruxolitinib phosphate
    D.3.9.1CAS number 2147706-60-1
    D.3.9.2Current sponsor codeCTP-543 phosphate
    D.3.9.3Other descriptive nameC-21543; D8-RUXOLITINIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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
    MODERATE TO SEVERE ALOPECIA AREATA IN ADULT PATIENTS
    ALOPECIA AREATA EN PACIENTES ADULTOS DE MODERADA A GRAVE
    E.1.1.1Medical condition in easily understood language
    EPISODE OF HAIR LOSS ASSOCIATED WITH ALOPECIA AREATA IN ADULT PATIENTS
    EPISODIO DE PÉRDIDA DE CABELLO ASOCIADO A ALOPECIA AREATA EN PACIENTES ADULTOS
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 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
    The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with moderate to severe alopecia areata
    Los objetivos generales del estudio son evaluar la seguridad a largo plazo de CTP-543 y valorar los efectos a largo plazo de CTP-543 en el tratamiento de la pérdida del cabello en pacientes adultos con alopecia areata de moderada a grave.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent, and authorization for release and use of protected health information.
    2.Have completed a 24-week Treatment Period in a previous qualifying CTP-543 clinical trial.
    3.Female subjects are eligible to participate if at least one of the following conditions applies:
    a) Is a woman of childbearing potential (WOCBP) and using a medically highly effective form of birth control with a failure rate less than 1% per year from at least 4 weeks prior to Baseline until at least 30 days following last dose of study drug. Examples of medically highly effective birth control methods include:
    i.Combined (estrogen and progestogen containing) hormonal contraception (oral, patch, vaginal ring)
    ii.Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
    iii.Intrauterine device or intrauterine hormone-releasing system
    iv.Bilateral tubal occlusion
    v.Vasectomized partner (partner is the sole sexual partner of the WOCBP trial participant and the vasectomized partner has received medical assessment of the surgical success)
    vi.Sexual abstinence (reliable as refraining from heterosexual intercourse during the above-mentioned period)
    b) Is not a WOCBP:
    i. Premenopausal with one of the following:
    a. Documented hysterectomy;
    b. Documented bilateral salpingectomy;
    c. Documented bilateral oophorectomy.
    ii. Postmenopausal (cessation of menses for at least 12 months prior to screening)
    Postmenopausal is defined as no menses for 12 months without an alternative medical cause. In addition, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm postmenopausal in women under 60 years old and not using hormonal contraception or hormone replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Females on HRT and whose menopausal status is in doubt will be required to use one of the nonestrogen hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment
    4.Male participants must:
    a.Agree to use, with their partners, male contraception (condom) and one of the highly effective contraceptive methods listed in Inclusion Criterion 3, from Baseline until at least 90 days following last dose of study drug.
    b.Refrain from donating sperm during the study and for at least 90 days after the end of the study.
    5.Willing to comply with the study visits and requirements of the study protocol.
    1. Consentimiento informado por escrito y autorización para la divulgación y el uso de información médica protegida.
    2. Haber completado un Periodo de Tratamiento de 24 semanas en un ensayo clínico de CTP-543 que haya cumplido los requisitos.
    3. Las mujeres son aptas para participar si se cumple al menos una de las siguientes condiciones:
    a) Ser una mujer en edad fértil (MEF) y utilizar un método anticonceptivo altamente eficaz desde el punto de vista médico con una tasa de fallo inferior al 1 % al año desde al menos 4 semanas antes del Inicio hasta al menos 30 días después de la última dosis del fármaco del estudio. Algunos ejemplos de métodos anticonceptivos de gran eficacia médica son los siguientes:
    i. Anticoncepción hormonal combinada (con estrógeno y progestágeno) (oral, parche, anillo vaginal)
    ii. Anticonceptivo hormonal solo con progestágeno asociado a la inhibición de la ovulación (oral, inyectable, implantable)
    iii. Dispositivo intrauterino o sistema intrauterino liberador de hormonas
    iv. Oclusión tubárica bilateral
    v. Tener pareja vasectomizada (la pareja es la única pareja sexual de la participante MEF que participa en el ensayo y la pareja vasectomizada ha recibido una evaluación médica satisfactoria de la intervención)
    vi. Abstinencia sexual (fiable se define como la abstinencia de relaciones heterosexuales durante el periodo mencionado).
    b) No es una MEF:
    i. Premenopáusica con una de las siguientes características:
    a. Histerectomía documentada;
    b. Salpingectomía bilateral documentada;
    c. Ovariectomía bilateral documentada.
    ii. Posmenopáusica (cese de la menstruación durante al menos 12 meses antes de la selección)
    Posmenopáusica se define como ausencia de menstruación durante 12 meses sin una causa médica alternativa. Además, se puede utilizar un nivel alto de hormona foliculoestimulante (FSH) en el intervalo posmenopáusico para confirmar la posmenopausia en mujeres menores de 60 años y que no utilizan anticonceptivos hormonales o terapia de reemplazo hormonal (TRH). Sin embargo, en ausencia de 12 meses de amenorrea, una sola medición de FSH es insuficiente. A las mujeres en TRH y cuyo estado de menopausia sea dudoso deberán utilizar alguno de los métodos anticonceptivos hormonales de gran eficacia sin estrógenos si desean continuar con el TRH durante el estudio. En caso contrario, deben interrumpir el TRH para permitir la confirmación del estado posmenopáusico antes de la inclusión en el estudio
    4. Los participantes de sexo masculino deben:
    a. Aceptar el uso, con sus parejas, de la anticoncepción masculina (preservativo) y alguno de los métodos anticonceptivos de gran eficacia mencionados en el criterio de inclusión 3, desde el Inicio hasta al menos 90 días después de la última dosis del fármaco del estudio.
    b. Abstenerse de donar esperma durante el estudio y durante al menos 90 días después del final del estudio.
    5. Estar dispuesto a cumplir con las visitas y los requisitos del protocolo del estudio.
    E.4Principal exclusion criteria
    1.Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body.
    2.Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication.
    3.Donation of blood at any point throughout the study and for 30 days after last dose of study medication.
    4.Most recent hematologic parameters do not permit continued dosing; i.e., criteria for withholding IP have been met and have not recovered to values required to resume dosing.
    5.Any medical, psychiatric, or social condition that is likely to unfavorably affect the risk-benefit of continued study participation, interfere with study compliance, or confound safety or efficacy assessments.
    1. Inflamación activa del cuero cabelludo, psoriasis o dermatitis seborreica que requiera tratamiento tópico en el cuero cabelludo, traumatismo significativo en el cuero cabelludo u otra afección en el cuero cabelludo que pueda interferir en la evaluación con SALT o queratosis actínica no tratada en cualquier parte del cuerpo.
    2. Mujeres en período de lactancia, embarazadas o que prevean quedarse embarazadas mientras participan en el estudio y durante 30 días después de la última dosis del medicamento del estudio.
    3. Donación de sangre en cualquier momento a lo largo del estudio y durante 30 días después de la última dosis del medicamento del estudio.
    4. La mayoría de los parámetros hematológicos recientes no permiten continuar con la administración; es decir, se han cumplido los criterios para suspender la administración del PEI y no se han recuperado los valores necesarios para reanudarla.
    5. Cualquier problema médico, psiquiátrico o social que pueda afectar desfavorablemente a la relación riesgo-beneficio de la participación continuada en el estudio, interferir con el cumplimiento del estudio o confundir las evaluaciones de seguridad o eficacia.
    E.5 End points
    E.5.1Primary end point(s)
    Safety of CTP-543 will be assessed by evaluating adverse event, clinical laboratories, physical examinations, vital signs, concomitant medications, and electrocardiogram results.
    Efficacy of CTP-543 will include all patients who receive study drug and have at least 1 post-treatment SALT assessment in this study. Relative change in SALT score over time will be summarized descriptively by visit, as appropriate.
    La seguridad de CTP-543 se evaluará mediante la valoración de los acontecimientos adversos, las mediciones de laboratorio, las exploraciones físicas, las constantes vitales, los medicamentos concomitantes y los resultados del electrocardiograma.
    La eficacia de CTP-543 incluirá a todos los pacientes que reciben el fármaco del estudio y tienen al menos 1 evaluación SALT posterior al tratamiento en este estudio. El cambio relativo en la puntuación SALT a lo largo del tiempo se resumirá de forma descriptiva por visita, según corresponda.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After at least 1 post-treatment SALT assessment (week 4) in this study
    Después de al menos 1 evaluación SALT posterior al tratamiento (semana 4) en este estudio
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    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 trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    LVLS
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 290
    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 Decision2022-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
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