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    EudraCT Number:2019-000733-39
    Sponsor's Protocol Code Number:ABX464-104
    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:2019-11-11
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-000733-39
    A.3Full title of the trial
    A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.
    Estudio en fase IIb, abierto, de la eficacia y la seguridad de ABX464 como tratamiento de mantenimiento en pacientes con colitis ulcerosa de moderada a intensa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients
    Tratamiento de mantenimiento abierto en pacientes con colitis ulcerosa de moderada a intensa
    A.4.1Sponsor's protocol code numberABX464-104
    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 SponsorABIVAX
    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 supportABIVAX
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro Medico Tecknon
    B.5.2Functional name of contact pointMiguel Sans Cuffi
    B.5.3 Address:
    B.5.3.1Street AddressCalle Vilana, 12
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08022
    B.5.4Telephone number+34690039598
    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 ABX464
    D.3.4Pharmaceutical form Capsule, hard
    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 INNABX464
    D.3.9.2Current sponsor codeABX464
    D.3.9.3Other descriptive nameABX464
    D.3.9.4EV Substance CodeSUB184487
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Ulcerative Colitis
    Español Colitis ulcerosa de moderada a intensa
    E.1.1.1Medical condition in easily understood language
    In Ulcerative Colitis the lining of the colon becomes inflamed and develops tiny open sores that produce pus and mucous.This causes abdominal discomfort and frequent emptying of the colon (diarrhoea).
    En la colitis ulcerosa el revestimiento del colon se inflama y desarrolla pequeñas llagas abiertas que producen pus y moco. Esto causa molestias abdominales y vaciado frecuente del colon (diarrea).
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess in all patients the long-term efficacy of ABX464 given at 50 mg QD on clinical remission at week 48 compared to the induction study baseline (ISB).
    El objetivo principal del estudio es evaluar en todos los pacientes la eficacia a largo plazo de ABX464 administrado en dosis de 50 mg 1 v/d en la remisión clínica en la semana 48 en comparación con el inicio del estudio de inducción (induction study baseline, ISB).
    E.2.2Secondary objectives of the trial
    To evaluate:
    -the clinical remission at week 48 compared to the baseline of the open label study (BOLS)
    - the proportion of patients with glucocorticoid-free clinical remission at W48
    -the effect of ABX464 50 mg QD:
    ~on Modified Mayo Score at week 48 and on partial MMS, among patients, at every study visit compared to ISB (Induction study baseline)
    ~on endoscopic improvement and remission and sustained endoscopic improvement and remission, by segment at W48 compared to ISB and BOLS
    ~on stool and rectal bleeding frequency at every study visit compared to BOLS
    ~on fecal calprotectin and CRP levels at W24 and W48 visits compared to BOLS
    ~on clinical response at W48 compared to ISB and BOLS
    ~on miR-124 expression in colon tissue (RNA later) and at W48 and in total blood at W24 and W48
    ~on patients’ quality of life at W24 and W48 compared to BOLS
    ~on the rectal/sigmoidal infiltrates at W48 compared to ISB and BOLS
    -the long-term safety profile of ABX464 50 mg QD
    - La remisión clínica en la semana 48 en comparación con el inicio del estudio abierto (baseline of the open label study, BOLS).
    - La proporción de pacientes con remisión clínica sin glucocorticoides en la semana 48.
    - El efecto de ABX464 50 mg 1 v/d:
    ~ En la puntuación Mayo modificada en la semana 48 y en la PMM parcial, entre los pacientes, en cada visita del estudio comparado con el SEL (inicio del estudio de inducción).
    ~ En la mejoría y remisión endoscópica y en la mejoría y remisión endoscópica mantenida por segmento en la S48 comparado con el SEL y el BOLS.
    ~ En la frecuencia de las deposiciones y sangrado rectal en cada visita del estudio comparado con el BOLS.
    ~ En los niveles de calprotectina fecal y de PCR en las visitas de la S24 y la S48 comparado con el BOLS.
    ~ En la respuesta clínica en la S48 comparado con el SEL y el BOLS.

    Ver protocolo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible to participate in this study if ALL the following criteria are met:
     Patients must have completed the 16-week induction treatment period (ABX464-103);
     Patients are able and willing to comply with study visits and procedures as per protocol;
     Patients should understand, sign and date the written voluntary informed consent form prior to any protocol-specific procedures are performed;
     Patients should be affiliated to a social security regimen (for French sites only);
     Females and males receiving the study treatment (potentially in combination with immunosuppressant) and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to screening. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True
    abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male patients should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male patients must not donate sperm as long as contraception is required.
    Un paciente será apto para participar en este estudio si cumple TODOS los criterios siguientes:
     Los pacientes deben haber completado el periodo de tratamiento de inducción de 16 semanas (ABX464-103).
     Los pacientes son capaces y están dispuestos a cumplir con las visitas y los procedimientos del estudio conforme al protocolo.
     Los pacientes deben entender, firmar y fechar el formulario de consentimiento informado voluntario por escrito antes de que se realice ningún procedimiento específico del protocolo.
     Los pacientes deben estar afiliados a un régimen de la seguridad social (solo para los centros de Francia).
     Las mujeres y los hombres que recibieron el tratamiento del estudio (posiblemente en combinación con inmunosupresor) y sus parejas deben acceder a usar un método anticonceptivo muy eficaz durante el estudio y durante 6 meses (180 días) después de la finalización del estudio o finalización anticipada. Se deben estar usando anticonceptivos al menos 2 semanas antes de la selección. Las mujeres deben ser quirúrgicamente estériles o si están en edad fértil deben usar un método anticonceptivo muy eficaz. Las mujeres en edad fértil (MEF) entrarán en el estudio después de confirmarse el periodo menstrual y un resultado negativo en la prueba de embarazo. Los métodos anticonceptivos altamente eficaces incluyen la abstinencia real, dispositivo intrauterino (DIU) o anticonceptivos hormonales que inhiben la ovulación, sistema intrauterino liberador de hormonas, ligadura de trompas bilateral, pareja vasectomizada. La abstinencia real se define como cuando esta se corresponde con la forma de vida preferida y habitual de la paciente. En cada caso de retraso del periodo menstrual (más de un mes entre menstruaciones) es obligatoria la confirmación de la ausencia de embarazo. Esta recomendación también es aplicable a MEF con ciclos menstruales irregulares o infrecuentes. Los pacientes varones y mujeres no deben planificar un embarazo durante el ensayo y durante 6 meses después de la finalización de su participación en el ensayo. Además, los pacientes varones deben usar preservativo durante el ensayo y durante los 6 meses (180 días) siguientes a la finalización de su participación en el estudio. Los pacientes varones no deben donar esperma mientras se requiera anticoncepción.
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria will be excluded from the study:
     Patients who had major protocol deviation(s) in the induction study;
     Patients who permanently discontinued study the treatment in induction study (ABX464-103) because of an adverse event (AE) regardless of relatedness to investigational product;
     Patients who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study;
     Patients with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for
    entry into this study;
     Patients who are participating or plan to participate in other investigational studies (other than induction study) during the study.
    Se excluirá del estudio a los pacientes que cumplan alguno de los siguientes criterios de exclusión:
     Pacientes que se hayan desviado del protocolo de forma importante en el estudio de inducción.
     Pacientes que hayan suspendido de forma permanente el tratamiento del estudio en el estudio de inducción (ABX464-103) a causa de un acontecimiento adverso (AA), independientemente de la relación con el producto en investigación.
     Pacientes que hayan desarrollado alguna enfermedad/afección importante o signos de una afección clínica inestable (excepto la CU) que, a criterio del investigador, aumentarán de forma sustancial el riesgo para el participante si participa en el estudio.
     Pacientes con alguna otra afección intensa médica o psiquiátrica, aguda o crónica, o alteraciones en la analítica o el electrocardiograma (ECG) que pudieran aumentar el riesgo asociado con la participación en el estudio o con la administración del producto en investigación, o que pudieran interferir con la interpretación de los resultados del estudio y, a juicio del investigador, hacer que el paciente no sea idóneo para participar en este estudio.
     Pacientes que estén participando o tengan previsto participar en otros estudios de investigación (distintos del estudio de inducción) durante el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with clinical remission at week 48 compared to induction study baseline.
    Clinical remission (based on the Mayo scoring system) is defined as: a rectal bleeding sub-score = 0,
    AND an endoscopy sub-score ≤1 (excluding friability), AND at least 1-point decrease in stool frequency sub-score from baseline to achieve a stool frequency sub-score ≤1.
    Proporción de pacientes con remisión clínica en la semana 48 en comparación con el inicio del estudio de inducción.
    La remisión clínica (basada en el sistema de puntuación Mayo) se define como una subpuntuación de hemorragia rectal = 0 Y una subpuntuación de la endoscopia ≤ 1 (excluida la friabilidad) Y un descenso en al menos 1 punto en la subpuntuación de la frecuencia de las deposiciones desde el inicio para lograr una subpuntuación de la frecuencia de las deposiciones ≤ 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 48
    En la semana 48
    E.5.2Secondary end point(s)
    Reduction relative to baseline in Modified Mayo Score at week 48 and in partial Modified Mayo Score at every study visit among all patients.
    Proportion of patients with either endoscopic improvement or/and endoscopic remission by segment at week 48 among all patients. Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability). Endoscopic remission is defined as a Mayo endoscopic sub score of 0.
    Proportion of patients with sustained endoscopic improvement at week 48. Sustained endoscopic improvement is defined as the number of patients with endoscopic improvement at week 48 among patients who had endoscopic improvement during the Induction study (at week 8 or week 16).
    Proportion of patients with glucocorticoid-free clinical remission at week 48. Glucocorticoid-free clinical remission is defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 8 weeks prior to week 48.
    Reduction relative to baseline in stool and rectal bleeding frequency at every study visit.
    Reduction relative to baseline in fecal calprotectin and CRP levels at week 24 and 48.
    Proportion of patients with clinical response at week 48.
    Clinical response is defined as: a reduction in Mayo Score ≥ 3 points and ≥ 30 % from baseline with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.
    Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at week 48 and in total blood at week 24 and week 48.
    Scores and changes from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) domains at week 24 and 48.
     Reduction relative to ISB of infiltrate/histopathology (rectal/ sigmoidal biopsies) using the Robarts Histopathology Index (RHI), the Geboes and Nancy Histology Scoring Scales at week 48.
    Number and rate of all adverse events, causally-related adverse events, all SAE and causallyrelated SAEs classified by severity.
    Incidence of treatment-emergent serious adverse event, hospitalizations, total inpatient days.
    Incidence of adverse events leading to investigational product discontinuation.
    Number of clinically significant laboratory abnormalities.
     Reducción con respecto al inicio en la puntuación de Mayo modificada en la semana 48 y en la puntuación parcial Mayo modificada en cada visita del estudio entre todos los pacientes.
     Proporción de pacientes con mejoría o remisión endoscópica por segmento en la semana 48 en todos los pacientes. La mejoría endoscópica se define como una subpuntuación Mayo endoscópica ≤ 1 (excluida friabilidad). La remisión endoscópica se define como una subpuntuación Mayo endoscópica de 0.
     La proporción de pacientes con mejoría endoscópica mantenida en la semana 48. La mejoría endoscópica mantenida se define como el número de pacientes con mejoría endoscópica en la semana 48 entre los pacientes que presentaron mejoría endoscópica durante el estudio de inducción (en las semanas 8 o 16).
     Proporción de pacientes con remisión clínica sin glucocorticoides en la semana 48. La remisión clínica sin glucocorticoides se define como remisión clínica además de que no se requiera ningún tratamiento con glucocorticoides durante al menos las 8 semanas anteriores a la semana 48.
     Reducción en relación con el inicio en la frecuencia de las deposiciones y del sangrado rectal en cada visita del estudio.
     Reducción con respecto al inicio en las concentraciones de calprotectina fecal y de PCR en las semanas 24 y 48.
     Proporción de pacientes con respuesta clínica en la semana 48. La respuesta clínica se define como una reducción en la puntuación Mayo ≥ 3 puntos y ≥ 30 % desde el inicio con un descenso acompañante de la subpuntuación del sangrado rectal ≥ 1 punto o de la subpuntuación del sangrado rectal absoluta ≤ 1 punto.
     Cambio con respecto al inicio en la expresión de miARN-124 en las biopsias rectales/sigmoideas en la semana 48 y en la sangre total en las semanas 24 y 48.
     Puntuaciones y cambios desde el inicio en los dominios del Cuestionario de enfermedad inflamatoria intestinal (CEII) en las semanas 24 y 48.
     Reducción con respecto al ISB en infiltrado/histopatología (biopsias rectales/sigmoideas) usando el índice de histopatología de Robarts (IHR), las escalas de puntuación histológica de Geboes y Nancy en la semana 48.
     Número y tasa de todos los acontecimientos adversos, acontecimientos adversos relacionados causalmente, todos los AAG y los AAG relacionados causalmente clasificados por intensidad.
     Incidencia de acontecimientos adversos graves durante el tratamiento, hospitalizaciones, días de ingreso totales.
     Incidencia de acontecimientos adversos que lleven a la interrupción del producto en investigación.
     Número de anomalías analíticas clínicamente significativas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) MMS at week 48 and pMMS at every visit
    2) at week 48
    3) at week 48
    4) at week 48
    5) at every study visit
    6) at week 24 and 48
    7) at week 48
    8) at week 24 and 48
    9) at week 24 and 48
    10) at week 48
    11) through the study
    12) through the study
    13) through the study
    14) through the study
    1) PMM en la semana 48 y PMMp en cada visita
    2) En la semana 48
    3) En la semana 48
    4) En la semana 48
    5) En cada visita del estudio
    6) En las semanas 24 y 48
    7) En la semana 48
    8) En las semanas 24 y 48
    9) En las semanas 24 y 48
    10) En la semana 48
    11) A lo largo del estudio
    12) A lo largo del estudio
    13) A lo largo del estudio
    14) A lo largo del estudio
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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. 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    Czech Republic
    United Kingdom
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 202
    F.4.2.2In the whole clinical trial 232
    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)
    No plans for treatment post-trial participation
    No hay planes de tratamiento tras la participación en el ensayo
    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 Decision2019-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
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