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    Summary
    EudraCT Number:2022-000239-21
    Sponsor's Protocol Code Number:MS200569_0048
    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:2022-11-14
    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 number2022-000239-21
    A.3Full title of the trial
    A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants with Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment
    Estudio de fase II, doble ciego, de rango de dosis, con grupos paralelos y de extensión a largo plazo para evaluar la seguridad y la eficacia de Enpatoran en participantes con lupus eritematoso cutáneo subagudo, lupus eritematoso discoide y/o lupus eritematoso sistémico que han completado el tratamiento del estudio WILLOW (MS200569_0003)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The WILLOW LTE study with enpatoran in participants with SCLE, DLE and/or SLE
    Estudio WILLOW ELP con enpatoran en participantes con LECS, LED y/o LES.
    A.3.2Name or abbreviated title of the trial where available
    WILLOW LTE
    WILLOW ELP
    A.4.1Sponsor's protocol code numberMS200569_0048
    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 SponsorMerck Healthcare KGaA
    B.1.3.4CountryGermany
    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 supportMerck Healthcare KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Healthcare KGaA
    B.5.2Functional name of contact pointCommunication Center
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Str. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+34900810844
    B.5.5Fax number+496151722000
    B.5.6E-mailservice@merckgroup.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 nameEnpatoran 25mg
    D.3.2Product code M5049
    D.3.4Pharmaceutical form Film-coated 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 INNEnpatoran
    D.3.9.1CAS number 2101938-42-3
    D.3.9.2Current sponsor codeM5049
    D.3.9.4EV Substance CodeSUB215545
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)
    Lupus Eritematoso Sistémico (LES) y Lupus Eritematoso Cutáneo (LEC)
    E.1.1.1Medical condition in easily understood language
    Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)
    Lupus Eritematoso Sistémico (LES) y Lupus Eritematoso Cutáneo (LEC)
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10056509
    E.1.2Term Cutaneous lupus erythematosus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057903
    E.1.2Term Subacute cutaneous lupus erythematosus
    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 enpatoran in participants with SCLE, DLE, and/or SLE
    Evaluar la seguridad y la eficacia a largo plazo del enpatoran en participantes con LECS, LED y/o LES.
    E.2.2Secondary objectives of the trial
    To evaluate the long-term safety and tolerability of enpatoran in participants with SCLE, DLE, and/or SLE.

    To evaluate the long-term efficacy in disease control of enpatoran in participants with SCLE, DLE, and/or SLE

    To evaluate the long-term efficacy in disease control of enpatoran in participants with SLE
    Evaluar la seguridad y tolerabilidad a largo plazo del enpatoran en participantes con LECS, LED y/o LES.

    Evaluar la eficacia a largo plazo del enpatoran en el control de la enfermedad en participantes con LECS, LED y/o LES.

    Evaluar la eficacia a largo plazo del enpatoran en el control de la enfermedad en participantes con LES.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are ≥ 18 and ≤ 76 years of age at the time of signing the informed consent.
    2. Are SCLE, DLE and/or SLE participants that have completed the 24-week Treatment of the WILLOW study.
    3. Have a BMI within the range 18.5 to 35.0 kg/m2 (inclusive).
    4. Male or Female
    The investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable. The contraception, barrier, and pregnancy testing requirements are below. Contraceptive use will be consistent with local regulations on contraception methods for those participating in clinical studies.
    a) Female participant:
    • Is not breastfeeding
    • Is not pregnant (i.e., has a negative highly sensitive urine pregnancy test, as required by local regulations, within 24 hours before the first dose of study intervention). If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
    •Is not a woman of childbearing potential (WOCBP)
    • If a WOCBP, use a highly effective contraceptive method (i.e., with a failure rate of < 1% per year), preferably with low user dependency (two methods may be considered to achieve optimal results i.e., < 1% failure rate per year), as described in Appendix 3 Contraception and Barrier Requirements for the following time periods:
    b) Male Participants:
    • Refrain from donating fresh unwashed semen.
    PLUS, either:
    • Abstain from any activity that allows for exposure to ejaculate.
    OR
    • Use a male condom:
    Agree to the following during the study until at least 90 days (a spermatogenesis cycle) after the last dose of study intervention.

    Please refer to the Protocol for additional details about this criteria.

    5. Are up to date, according to local guidelines, with vaccination against Streptococcus pneumoniae and influenza virus (as seasonally required for influenza virus).
    6. Capable of giving signed informed consent, as indicated in Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and this protocol.
    1. Tener ≥18 y ≤76 años en el momento de la firma del consentimiento informado.
    2. Ser participantes con LECS, LED o LES que hayan completado el tratamiento de 24 semanas del estudio WILLOW.
    3. Tener un IMC dentro del intervalo de 18,5 a 35,0 kg/m2 (inclusive).
    4. Hombre o mujer
    El investigador confirma que todos los participantes aceptan usar métodos anticonceptivos y de barrera adecuados, si procede. Los requisitos anticonceptivos, de métodos de barrera y sobre las pruebas de embarazo se muestran a continuación. El uso de anticonceptivos debe realizarse de conformidad con las normativas locales relativas a los métodos anticonceptivos para los participantes en estudios clínicos.
    a) Participante de sexo femenino:
    • No estar en periodo de lactancia.
    • No estar embarazada (es decir, obtiene un resultado negativo en una prueba de embarazo en orina de alta sensibilidad, según lo exigido por la normativa local, en las 24 horas previas a la primera dosis del tratamiento del estudio). Si no se puede confirmar el resultado negativo de una prueba en orina (p. ej., en caso de un resultado ambiguo), será necesaria una prueba de embarazo en suero.
    • No es una mujer con posibilidad de quedarse embarazada (MPE).
    Si es una MPE, debe utilizar un método anticonceptivo de alta eficacia (es decir, con una tasa de ineficacia <1 % al año), de preferencia con baja dependencia del usuario (puede considerarse que dos métodos alcanzan resultados óptimos, es decir, una tasa de ineficacia <1 % al año), como se describe en el anexo 3 Requisitos anticonceptivos y de métodos de barrera, durante los siguientes periodos:
    b) Participantes de sexo masculino:
    • Abstenerse de donar semen reciente no lavado. ADEMÁS DE:
    • Abstenerse de cualquier actividad que permita la exposición a una eyaculación.
    O BIEN
    • Utilizar un preservativo masculino:
    Deberán aceptar lo siguiente durante el estudio hasta al menos 90 días (un ciclo de espermatogénesis) después de la última dosis del tratamiento del estudio.

    Por favor, revisar el Protocolo para detalles adicionales sobre este criterio.

    5. Estar al día, según las directrices locales, de la vacunación contra Streptococcus pneumoniae y el virus de la gripe (según se requiera en la temporada del virus de la gripe).
    6. Poder otorgar un consentimiento informado firmado, como se indica en el anexo 2, lo que incluye el cumplimiento de los requisitos y restricciones enumerados en el FCI y en este protocolo.
    E.4Principal exclusion criteria
    1. Participants who experienced serious event(s) related to the study intervention during the WILLOW study, an unstable medical condition, or any other reason, in the opinion of the Investigator or Sponsor/designee that would preclude participation in this LTE study.
    2. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with LTE study participation or study intervention administration and, in the judgement of the Investigator or Sponsor/designee opinion, would make the participant inappropriate to participate in this LTE study.
    3. Active clinically significant viral (including SARS-CoV-2), bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered sufficiently controlled will not be exclusionary. Note: if sign/symptoms suggest any underlying infection (at Investigator discretion), a negative or normal test result must be provided and discussed with the Medical Monitor.
    • In Japan and in other countries if required per local guidelines, participants who entered the WILLOW study with positive anti HBc antibody and/or anti-HBs antibody with non-detectable HBV DNA at Screening must provide a negative HBV DNA PCR result.
    4. Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24/EOT Visit (may require prior discussion with medical monitor).
    5. Participation in any other investigational drug study after the WILLOW study Week 24/EOT Visit.
    6. Withdrawn during the WILLOW study due to any of the pre-defined criteria for study intervention or study withdrawal.
    7. Planned major elective medical or surgical procedure.
    8. Breastfeeding/lactating or pregnant women. Lactating women are excluded regardless of whether or not they are nursing infant(s).
    1. Participantes que presenten acontecimientos graves relacionados con el tratamiento del estudio durante el estudio WILLOW, una afección médica inestable o cualquier otra razón que, a juicio del investigador o del promotor/persona designada, impidieran la participación en este estudio de ELP.
    2. Otras afecciones médicas o psiquiátricas agudas o crónicas graves o anomalías analíticas que puedan aumentar el riesgo asociado con la participación en el estudio de ELP o con la administración del tratamiento del estudio y que, a juicio del investigador o el promotor/persona designada, hicieran que no fuera adecuado que el sujeto participara en este estudio de ELP.
    3. 3. Infección vírica, bacteriana o fúngica clínicamente significativa y activa (incluido el SARS-CoV-2) o cualquier episodio importante de infección que requiera hospitalización o tratamiento con fármacos contra las infecciones por vía parenteral. La candidiasis vaginal, la onicomicosis y los virus del herpes simple o común bucal o genital que se consideren suficientemente controlados no serán excluyentes. Nota: Si los signos o síntomas sugieren alguna infección subyacente (a criterio del investigador), se debe proporcionar un resultado negativo o normal de la prueba y comentarlo con el monitor médico.
    • En Japón y en otros países, en función de las directrices locales, los participantes que entraron en el estudio WILLOW con anticuerpo anti-HBc positivo o anticuerpos anti-HBs con ADN del VHB no detectable en la selección deberán proporcionar un resultado negativo en la PCR de ADN del VHB.
    4. Haber recibido medicación prohibida en la ELP durante el estudio WILLOW o después de la visita de la semana 24/FdT del estudio WILLOW (puede requerir una consulta previa con el monitor médico).
    5. Participación en cualquier otro estudio con un fármaco en investigación después de la visita de la semana 24/FdT del estudio WILLOW.
    6. Haberse retirado durante el estudio WILLOW debido a cualquiera de los criterios predefinidos para el tratamiento del estudio o la retirada del estudio.
    7. Intervención médica o quirúrgica mayor programada.
    8. Mujeres embarazadas o en periodo de lactancia. Las mujeres en periodo de lactancia están excluidas, independientemente de si están amamantando o no.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of adverse events (treatment-emergent adverse events [TEAEs], serious adverse events [SAEs], and adverse events of special interest [AESIs]) from Day 1 through the end of the Safety Follow-up period (up to Week 50)
    Aparición de acontecimientos adversos (acontecimientos adversos surgidos durante el tratamiento [AAST], acontecimientos adversos graves [AAG] y acontecimientos adversos de especial interés [AAEI]) desde el día 1 hasta el final del periodo de seguimiento de la seguridad (hasta la semana 50).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Day 1 through the end of the Safety Follow-up period (up to Week 50)
    Desde el día 1 hasta el final del periodo de seguimiento de la seguridad (hasta la semana 50)
    E.5.2Secondary end point(s)
    Occurrence of abnormalities (Grade ≥ 3) in laboratory parameters
    Occurrence of clinically important increases in QTcF

    Percent change from WILLOW study baseline in CLASI-A score at Weeks 0, 2, 4, 12, 24, 36, and 48
    Change from WILLOW study baseline in CLA-IGA at Weeks 0, 2, 4, 12, 24, 36, and 48

    BICLA response at Weeks 24 and 48
    SRI-4 response at Weeks 24 and 48
    Aparición de anomalías (grado ≥3) en los parámetros analíticos.
    Aparición de aumentos clínicamente importantes en el QTcF.

    Cambio porcentual desde los valores iniciales en el estudio WILLOW en la puntuación CLASI-A en las semanas 0, 2, 4, 12, 24, 36 y 48.
    Cambio con respecto a los valores iniciales del estudio WILLOW en
    CLA-IGA en las semanas 0, 2, 4, 12, 24, 36 y 48.

    Respuesta BICLA en las semanas 24 y 48
    Respuesta SRI-4 en las semanas 24 y 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 0, 2, 4, 12, 24, 36, and 48

    Weeks 24 and 48
    Semanas 0, 2, 4, 12, 24, 36 y 48.

    Semanas 24 y 48.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Diferente dosis del mismo producto
    Different dose of the same product
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Brazil
    Chile
    China
    Colombia
    Israel
    Japan
    Korea, Republic of
    Mauritius
    Mexico
    Philippines
    South Africa
    Taiwan
    United States
    Poland
    Bulgaria
    Romania
    Spain
    Greece
    Moldova, Republic of
    Russian Federation
    Ukraine
    Serbia
    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 scheduled procedure for the last participant in the study globally.
    El último procedimiento programado para el último participante en el estudio global.
    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 months6
    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 months6
    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: 430
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-11-14. Yes
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 113
    F.4.2.2In the whole clinical trial 440
    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 Decision2022-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-08
    P. End of Trial
    P.End of Trial StatusOngoing
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