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    Summary
    EudraCT Number:2021-003543-16
    Sponsor's Protocol Code Number:LP0133-1528
    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:2021-12-10
    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 number2021-003543-16
    A.3Full title of the trial
    A 24 week, randomised, assessor blinded, active-controlled, parallel group, phase 3, 2 arm trial to compare the efficacy and safety of delgocitinib cream 20 mg/g twice-daily with alitretinoin capsules once-daily in adult participants with severe chronic hand eczema
    Ensayo de fase 3, aleatorizado, controlado con principio activo, de 2 grupos paralelos, con enmascaramiento para el evaluador y 24 semanas de duración, para comparar la eficacia y la seguridad de delgocitinib crema de 20 mg/g dos veces al día frente a alitretinoína, cápsulas una vez al día, en participantes adultos con eczema de manos crónico severo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 24 week trial to compare the efficacy and safety of delgocitinib cream 20 mg/g twice-daily with alitretinoin capsules once-daily in adult participants with severe chronic hand eczema
    Ensayo de 24 semanas para comparar la eficacia y la seguridad de delgocitinib crema de 20 mg/g dos veces al día frente a alitretinoína, cápsulas una vez al día, en participantes adultos con eczema de manos crónico severo
    A.3.2Name or abbreviated title of the trial where available
    DELTA FORCE
    DELTA FORCE
    A.4.1Sponsor's protocol code numberLP0133-1528
    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 SponsorLEO Pharma A/S
    B.1.3.4CountryDenmark
    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 supportLEO Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLEO Pharma A/S
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressIndustriparken 55
    B.5.3.2Town/ cityBallerup
    B.5.3.3Post code2750
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4553599323
    B.5.6E-mailfmedk@leo-pharma.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 nameDelgocitinib
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDelgocitinib
    D.3.9.1CAS number 1263774-59-9
    D.3.9.2Current sponsor codeLEO 124249
    D.3.9.3Other descriptive nameLEO 124249A, JTE052
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Toctino
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline UK Limited (Trading as Stiefel)
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Capsule, soft
    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 INNALITRETINOIN
    D.3.9.1CAS number 5300-03-8
    D.3.9.4EV Substance CodeSUB00344MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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: 3
    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 Toctino
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline UK Limited (Trading as Stiefel)
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Capsule, soft
    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 INNALITRETINOIN
    D.3.9.1CAS number 5300-03-8
    D.3.9.4EV Substance CodeSUB00344MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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
    Chronic Hand Eczema
    Eczema de manos crónico
    E.1.1.1Medical condition in easily understood language
    Severe Hand Eczema
    Eczema de manos crónico
    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 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084778
    E.1.2Term Chronic hand eczema
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy and health-related quality of life of twice-daily topical application of delgocitinib cream with once-daily oral administration of alitretinoin capsules in the treatment of patients with severe CHE.
    Comparar la eficacia y la calidad de vida relacionada con la salud de la aplicación tópica dos veces al día de delgocitinib en crema frente a la administración oral una vez al día de alitretinoína en cápsulas en el tratamiento de pacientes con CHE severo.
    E.2.2Secondary objectives of the trial
    To compare the safety of twice-daily topical application of delgocitinib cream with once-daily oral administration of alitretinoin capsules in the treatment of patients with severe CHE.
    Comparar la seguridad de la aplicación tópica dos veces al día de delgocitinib en crema frente a la administración oral una vez al día de alitretinoína en cápsulas en el tratamiento de pacientes con CHE severo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be at least 18 years of age inclusive, at the time of signing the informed consent
    2. Diagnosis of CHE defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months.
    3. Disease severity graded as severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 4).
    4. Documented recent history of inadequate response to treatment with TCS (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable
    5. Participant is adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
    6. Contraceptive use must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    1. El participante debe tener como mínimo 18 años de edad en el momento de firma del consentimiento informado
    2. Diagnóstico de eczema de manos crónico (CHE), definido como un edema de manos que ha persistido durante más de 3 meses o que ha reaparecido dos o más veces en los 12 últimos meses.
    3. Enfermedad de intensidad calificada como severa en la selección y en el basal según IGA-CHE (esto es, una puntuación IGA-CHE de 4).
    4. Historia reciente documentada de respuesta inadecuada al tratamiento con TCS (en cualquier momento en el plazo del 1 año anterior a la visita de Selección) o con contraindicación documentada al uso de TCS
    5. El participante observa las medidas no médicas habituales de cuidados cutáneos, lo que incluye evitar los irritantes y alérgenos conocidos y relevantes.
    6. Su uso de medidas anticonceptivas deberá concordar con las normativas locales en cuanto a los métodos anticonceptivos para los participantes en estudios clínicos.
    E.4Principal exclusion criteria
    1. Concurrent skin diseases on the hands.
    2. Active atopic dermatitis requiring medical treatment in regions other than the hands and feet.
    3. Active psoriasis on any part of the body.
    4. Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
    5. Clinically significant infection on the hands.
    6. Participants who cannot receive alitretinoin
    7. Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with the evaluation of the IMP, or reduce the participant´s ability to participate in the trial.
    8. History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant’s verbal report.
    9. Any disorder that is not stable and could: a) Affect the safety of the participant throughout the trial b) Impede the participant´s ability to complete the trial.
    10. Positive HBsAg or HCV antibody serology at screening.
    11. Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 28 days prior to baseline.
    12. Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days prior to baseline.
    13. Previous or current treatment with JAK inhibitors, systemic or topical.
    14. Cutaneously applied treatment with immunomodulators or TCS on the hands within 14 days prior to baseline.
    15. Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.
    16. Other transdermal and cutaneously applied therapy on the hands (except for the use of participant´s own emollients) within 7 days prior to baseline.
    17. Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern, within 7 days prior to baseline.
    18. Treatment with any marketed biological therapy or investigational biologic agents, except vaccines:
    a. Any cell-depleting agents including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
    b. Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
    19. Previously used alitretinoin or participated in a clinical trial with alitretinoin or delgocitinib.
    1. Otras enfermedades cutáneas actuales de las manos.
    2. Dermatitis atópica activa que precisa tratamiento médico en regiones distintas de manos y pies.
    3. Psoriasis activa en cualquier parte del cuerpo.
    4. Eczema de manos hiperqueratósico junto con historia de psoriasis en cualquier parte del cuerpo.
    5. Infección clínicamente importante en las manos.
    6. Participantes que no pueden recibir alitretinoína
    7. Infección clínicamente importante en el plazo de los 28 días anteriores al momento basal que, en opinión del investigador, podría afectar a la seguridad del participante en el ensayo, interferir con la evaluación del producto en investigación o reducir la capacidad del sujeto para participar en el ensayo.
    8. Historia de cualquier trastorno de inmunodeficiencia primaria, incluida la positividad del HIV en la selección, o participante en tratamiento con antirretrovirales, según se desprende de la historia médica y/o de su comunicación verbal por el participante.
    9. Todo trastorno que no se encuentre estable y que pueda: a) afectar a la seguridad del participante a lo largo del ensayo, b) disminuir la capacidad del participante de completar el ensayo.
    10. Serología positiva de HBsAg o anticuerpos anti-HCV en la selección.
    11. Tratamiento sistémico con inmunosupresores, inmunomoduladores, retinoides o corticosteroides en el plazo de los 28 días anteriores al momento basal.
    12. Uso de cabinas de bronceado, fototerapia o baños de lejía en las manos en el plazo de los 28 días anteriores al momento basal.
    13. Tratamiento previo actual con inhibidores de JAK, sistémicos o tópicos.
    14. Aplicación cutánea en manos de inmunomoduladores o TCS en el plazo de los 14 días anteriores al momento basal.
    15. Uso de antibióticos sistémicos o de aplicación cutánea en las manos en el plazo de los 14 días anteriores al momento basal.
    16. Otro tratamiento transdérmico o de aplicación cutánea en las manos (excepto el uso de sus cremas hidratantes por el propio participante) en el plazo de los 7 días anteriores al momento basal.
    17. Tratamientos aplicados cutáneamente en regiones distintas de las manos que pudieran interferir con las evaluaciones clínicas o suponer un problema de seguridad, en el plazo de los 7 días anteriores al basal.
    18. Tratamiento con cualquier agente biológico comercializado o en fase de investigación, a excepción de vacunas:
    a. Todo agente de depleción celular, tal como, entre otros, el rituximab: en el plazo de los 6 meses anteriores al momento basal o hasta que el recuento de linfocitos vuelva la normalidad, eligiéndose el mayor de estos plazos.
    b. Otros agentes biológicos: en el plazo de 3 meses o de 5 semividas del producto, eligiéndose el más prolongado de estos, antes del momento basal.
    19. Uso previo de alitretinoína o participación en un ensayo clínico con alitretinoína o delgocitinib.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    - Change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12.
    Criterios de valoración principal:
    - Cambio en la puntuación del Hand Eczema Severity Index (HECSI) desde el basal a la Semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    from baseline to Week 12
    Desde el basal a la Semana 12
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    • HECSI-90 (at least 90% improvement in HECSI score from baseline) at Week 12.
    • Investigator´s Global Assessment for chronic hand eczema© treatment success (IGA-CHE TS) at Week 12.
    • Change in Hand Eczema Symptom Diary© (HESD) itch score (weekly average) from baseline to Week 12.
    • Change in HESD pain score (weekly average) from baseline to Week 12.
    • AUC of HECSI-90 from baseline up to Week 24.
    • AUC of change from baseline in Dermatology Life Quality Index (DLQI) score up to Week 24.
    • Change in HECSI score from baseline to Week 24.

    Secondary endpoints:
    • Number of treatment-emergent AEs from baseline up to Week 26.
    • Number of treatment-emergent SAEs from baseline up to Week 26.
    • Number of AEs leading to IMP discontinuation up to Week 24.
    Criterios de valoración secundarios clave:
    • HECSI-90 (mejoría de como mínimo el 90% en la puntuación del HECSI frente al basal) en la Semana 12.
    • Investigator´s Global Assessment for chronic hand eczema© treatment success (IGA-CHE TS) en la Semana 12.
    • Cambio en la puntuación de prurito del Hand Eczema Symptom Diary© (HESD) (media semanal) desde el momento basal a la Semana 12.
    • Cambio en la puntuación de dolor del HESD (media semanal) desde el basal a la Semana 12.
    • AUC del HECSI-90 desde el basal hasta la Semana 24.
    • AUC del cambio en la puntuación del Dermatology Life Quality Index (DLQI) desde el basal hasta la Semana 24.
    • Cambio en la puntuación del HECSI desde el basal a la Semana 24.
    Criterios de valoración secundarios:
    • Número de acontecimientos adversos surgidos durante el tratamiento desde el basal hasta la Semana 26.
    • Número de acontecimientos adversos graves surgidos durante el tratamiento desde el basal hasta la Semana 26.
    • Número de acontecimientos adversos resultantes en el abandono del medicamento en investigación hasta la Semana 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    from baseline up to Week 26
    Desde el basal hasta la Semana 26
    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 Yes
    E.6.13.1Other scope of the trial description
    Health Related Quality of Life
    Health Related Quality of Life
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Enmascaramiento del tratamiento para el evaluador
    Assessor blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Austria
    Canada
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    France
    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
    The end of the trial is defined as the date of the last visit of the last participant in the trial.
    Se define como fin del ensayo la fecha de la última visita del último participante en el ensayo.
    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 months6
    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 months6
    E.8.9.2In all countries concerned by the trial days15
    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: 459
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 439
    F.4.2.2In the whole clinical trial 510
    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)
    After the end of the trial, participants will be treated at the investigator´s discretion or referred to other physician(s) according to standard practice.
    Una vez finalizado el ensayo, los participantes recibirán tratamiento a criterio por el investigador o, dependiendo de la práctica habitual, se remitirán a otro u otros médicos.
    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 Decision2022-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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