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    Summary
    EudraCT Number:2018-003135-30
    Sponsor's Protocol Code Number:URO-901-3005
    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:2019-12-02
    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 number2018-003135-30
    A.3Full title of the trial
    A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men with Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
    Estudio de fase 3, en doble ciego, aleatorizado, controlado con placebo y multicéntrico, para evaluar la eficacia, seguridad y tolerabilidad de vibegrón en varones con síntomas de vejiga hiperactiva en tratamiento farmacológico por hiperplasia prostática benigna
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate vibegron in men taking stable BPH medications who have overactive bladder symptoms
    Estudio para evaluar vibegrón en varones con síntomas de vejiga hiperactiva en tratamiento farmacológico por hiperplasia prostática benigna
    A.3.2Name or abbreviated title of the trial where available
    Vibegron in Men with BPH with OAB
    Vibegron en Varones con HPB con SVH
    A.4.1Sponsor's protocol code numberURO-901-3005
    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 SponsorUrovant Sciences GmbH
    B.1.3.4CountrySwitzerland
    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 supportUrovant Sciences GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUrovant Sciences GmbH
    B.5.2Functional name of contact pointClinical Trial Information Contact
    B.5.3 Address:
    B.5.3.1Street AddressViaduktstrasse 8
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4051
    B.5.3.4CountrySwitzerland
    B.5.6E-mailinfo@urovant.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 nameVibegron
    D.3.2Product code URO-901, RVT-901
    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 INNVIBEGRON
    D.3.9.1CAS number 1190389-15-1
    D.3.9.2Current sponsor codeURO-901, RVT-901
    D.3.9.4EV Substance CodeSUB189006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    Overactive Bladder (OAB) in men with Benign Prostatic Hyperplasia (BPH)
    Varones con hiperplasia prostática benigna (BPH) y vejiga hiperactiva (OAB)
    E.1.1.1Medical condition in easily understood language
    Overactive bladder (OAB)
    Vejiga hiperactiva (OAB)
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy, safety, and tolerability of vibegron versus placebo in men with OAB symptoms on pharmacological therapy for BPH
    Determinar la eficacia, seguridad y tolerabilidad de vibegrón frente a placebo en varones con síntomas de OAB en tratamiento farmacológico por BPH.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of vibegron compared with placebo in men with OAB symptoms on pharmacological therapy for BPH as defined by other key measures
    Evaluar la eficacia de vibegrón frente a placebo en varones con síntomas de vejiga hiperactiva en tratamiento farmacológico por hiperplasia prostática benigna, en función de otras medidas clave
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    SUB-STUDY IS APPLICABLE ONLY FOR THE UNITED STATES

    Urodynamics Assessments
    For the 60 subjects participating in the urodynamics sub-study in Part 2, urodynamics will be taken at Baseline and Week 12 to measure certain parameters
    EL SUB-ESTUDIO ES SOLO APLICABLE PARA ESTADOS UNIDOS

    Evaluaciones urodinámicas
    En los 60 sujetos que participen en el subestudio urodinámico en la Parte 2, se efectuarán evaluaciones urodinámicas en el momento Basal y en la Semana 12 para determinar ciertos parámetros.
    E.3Principal inclusion criteria
    1. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    2. Male subjects of 45 years of age and above.
    3. Body weight ≥ 50 kg (inclusive).
    4. Subject should have been on and agree to continue to stay on a stable dose of BPH treatment with either a) alpha blocker monotherapy or b) alpha blocker + 5 ARI. Subjects on alpha blockers should have started their therapy at least 3 months prior to screening and be on a stable dose at the start of screening. Subjects on a 5-ARI should have started therapy at least 6 months prior to screening and be on a stable dose at screening.
    5. Has a history of overactive bladder symptoms (frequency of ≥ 8 micturition episodes per day and urgency episodes of ≥ 3 per day with or without incontinence) while taking pharmacological therapy for at least 2 months to treat LUTS due to BPH.
    6. Subject has an IPSS total score of ≥ 8 at Screening and Visit 3 (Baseline).
    7. Subject has a prostate-specific antigen (PSA) level < 4 ng/mL, or if ≥ 4 ng/mL but ≤ 10 ng/mL, prostate cancer has been ruled out to the satisfaction of the investigator.
    8. Subjects agrees to not participate in another interventional drug or device clinical trial during the study.
    9. In the opinion of the investigator, is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the Bladder Diary.
    10. At Visit 2 (Run-in) and Visit 3 (Baseline) visits, subject must have both additional qualifications based on the 3-day Bladder Diary period: a) having an average of ≥ 8 but ≤ 20 micturition episodes per day over the 3-day diary period, and (b) having an average of ≥ 3 urgency episodes per day over the 3-day diary period.
    11. Subject must have a post void residual (PVR) volume value of < 100 mL at Screening, Visit 2 (Run-In) and Visit 3 (Baseline).
    12. At Visit 2 (Run-in) and Visit 3 (Baseline) visits, having at least 2 average nocturia episodes per night based on 3-day Bladder Diary at baseline. Nocturia is defined as waking to pass urine during the main sleep period.
    1. Sujeto capaz de otorgar el consentimiento informado por escrito, lo que incluye el cumplimiento de los requisitos y las restricciones que se señalan en el documento de consentimiento.
    2. Varón de 45 años o más.
    3. Con peso corporal ≥ 50 kg (inclusive).
    4. Sujeto que ha estado recibiendo y acepta continuar recibiendo una dosis estable de tratamiento para la hiperplasia prostática benigna con: a) bloqueante alfa en monoterapia o b) bloqueante alfa + inhibidor de la 5-alfa-reductasa. Los sujetos que reciban bloqueantes alfa deberán haber comenzado el tratamiento por lo menos 3 meses antes de la selección y hallarse con una dosis estable al inicio de la selección. Los sujetos que reciban inhibidores de la 5-alfa-reductasa deberán haber comenzado el tratamiento por lo menos 6 meses antes de la selección y hallarse con una dosis estable en la selección.
    5. Sujeto con antecedentes de síntomas de vejiga hiperactiva (polaquiuria >=8 episodios miccionales al día y >=3 episodios de micción imperiosa al día, con o sin incontinencia) durante un tratamiento farmacológico de por lo menos 2 meses de duración para síntomas de vías urinarias bajas debidos a hiperplasia prostática benigna.
    6. Sujeto con una puntuación total del Índice internacional de síntomas prostáticos (International Prostate Symptom Score, IPSS) >=8 en la Selección y en la Visita 3 (Basal).
    7. Sujeto con un nivel de antígeno prostático específico (PSA) <4 ng/ml o, si fuera >=4 ng/ml pero <=10 ng/ml, se ha descartado el cáncer de próstata a satisfacción del investigador.
    8. Sujeto que acepta no participar en otro ensayo clínico con un medicamento o producto sanitario en investigación durante el estudio.
    9. Sujeto capaz y dispuesto, en opinión del investigador, a cumplir los requisitos del protocolo, lo que comprende la cumplimentación de los cuestionarios del estudio y el Diario Miccional.
    10. Sujeto que en la Visita 2 (Preinclusión) y en la Visita 3 (Basal) cumple los requisitos adicionales según el Diario Miccional de 3 días:
    a) promedio >=8 pero <=20 episodios miccionales al día durante el periodo del diario de 3 días, y
    b) promedio >=3 episodios de micción imperiosa al día durante el periodo del diario de 3 días.
    11. Sujeto con un volumen residual posmiccional <100 ml en la Selección, en la Visita 2 (Preinclusión) y en la Visita 3 (Basal).
    12. Sujeto que en la Visita 2 (Preinclusión) y en la Visita 3 (Basal) presenta un promedio de por lo menos 2 episodios de nicturia por noche según el Diario Miccional de 3 días en el momento basal. Se define como nicturia el despertar para orinar durante el periodo de sueño principal.
    E.4Principal exclusion criteria
    1. Subject has a history of 24-hour urine volume greater than 3,000 mL or over 3,000 mL based on 3-day Bladder Diary at Visit 2 (Run-In ) or Visit 3 (Baseline) visits.
    2. Has lower urinary tract pathology that could, in the opinion of the investigator, be responsible for urgency, frequency, or incontinence; including, but not limited to, bladder stones, interstitial cystitis, prostate cancer, persistent urethral stricture, urogenital tuberculosis, and urothelial tumor.
    3. Has a history of prostate surgery, including minimally invasive transurethral or transrectal procedures, procedural treatments for BPH within 6 months of Screening or has a planned prostate surgery, including minimally invasive prostate procedures, during the study period. Has a previous or planned pelvic radiation, low anterior resections (LAR), or any abdominoperineal resections (APR) during the study period.
    4. Has a history of urinary retention requiring an intervention (eg, catheterization) for any reason.
    5. Has maximum urinary flow (Qmax) < 5.0 mL/second with a minimum voided volume of 125 mL at Screening and Visit 3 (Baseline).
    6. Has a history of or current nocturnal polyuria at Visit 2 (Run-In ) or Visit 3 (Baseline) visits, based on 3-day Bladder Diary. Nocturnal polyuria is defined as more than one third of the total urine output per 24 hours occurring at night time.
    7. Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or laboratory criteria (≥ 5 white blood cells [WBC]/hpf with presence of red blood cell [RBC] and/or a positive urine culture, defined as ≥ 105colony forming units [CFU]/mL in 1 specimen). Subjects diagnosed with a urinary tract infection (UTI) at the Screening Visit may be treated until the infection has resolved.
    8. Has an implanted sacral neurostimulation (SNS) or use of any posterior tibial nerve stimulation (PTNS) device.
    9. Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 mg/dL or 8.33 mmol/L or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the investigator, is uncontrolled.
    10. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mmHg and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute.
    11. Subjects who have systolic blood pressures ≥ 160 mmHg but < 180 mmHg are excluded, unless deemed by the investigator as safe to proceed in this study and able to complete the study per protocol; these subjects must be on stable hypertension medication for at least 3 months prior to Screening Visit.

    For the complete list of exclusion criteria please refer to Study Protocol
    1. Sujeto con antecedentes de volumen de orina de 24 horas mayor de 3000 ml o con un valor superior a 3000 ml según el Diario Miccional de 3 días en la Visita 2 (Preinclusión) o en la Visita 3 (Basal).
    2. Con algún proceso patológico de las vías urinarias inferiores que, en opinión del investigador, sea el causante de la micción imperiosa, la polaquiuria o la incontinencia, como, entre otros, cálculos vesicales, cistitis intersticial, cáncer de próstata, estenosis uretral persistente, tuberculosis genitourinaria y tumor urotelial.
    3. Con antecedentes de cirugía prostática, incluidas las intervenciones transuretrales o transrectales mínimamente invasivas, tratamientos quirúrgicos para la hiperplasia prostática benigna en el plazo de los 6 meses anteriores a la Selección o cirugía prostática programada, incluidas las intervenciones prostáticas mínimamente invasivas, durante el periodo del estudio. Con antecedentes o previsión de radioterapia pélvica, resecciones anteriores bajas o resecciones abdominoperineales durante el periodo del estudio.
    4. Con antecedentes de retención urinaria que precise intervención (por ejemplo, sondaje) por cualquier motivo.
    5. Con un flujo urinario máximo (Qmax) <5,0 ml/s junto a un volumen mínimo evacuado de 125 ml en la Selección y en la Visita 3 (Basal).
    6. Con antecedentes o presencia de poliuria nocturna en la Visita 2 (Preinclusión) o en la Visita 3 (Basal) según el Diario Miccional de 3 días. La poliuria nocturna se define como la excreción por la noche de más de un tercio de la diuresis total de 24 horas.
    7. Con infección urinaria activa o recurrente (>3 episodios al año), diagnosticada por el cuadro clínico o por criterios de laboratorio (>=5 leucocitos/campo de gran aumento y presencia de hematíes y/o urocultivo positivo, definido como >=105 unidades formadoras de colonias/ml en 1 muestra). Los sujetos con diagnóstico de infección urinaria en la Visita de Selección podrán recibir tratamiento hasta que se resuelva la infección.
    8. Que lleve implantado un dispositivo de neuroestimulación sacra o que utilice un dispositivo de estimulación del nervio tibial posterior.
    9. Con hiperglucemia no controlada (definida como glucemia en ayunas >150 mg/dl u 8,33 mmol/l o glucemia sin estar en ayunas >200 mg/dl o 11,1 mmol/l) o que el investigador considere que no está controlada.
    10. Con hipertensión arterial no controlada (presión arterial sistólica >=180 mmHg y/o diastólica >=100 mmHg) o frecuencia cardiaca (según el pulso) en reposo >=100 latidos por minuto.
    11. Se excluirá del estudio a los sujetos con presión arterial sistólica >=160 mmH pero <180 mmHg, salvo que el investigador considere que el sujeto va a poder participar sin riesgo indebido en este estudio y concluirlo conforme al protocolo; estos sujetos deberán mantenerse con dosis estables de medicación antihipertensiva desde por lo menos 3 meses antes de la Visita de Selección.
    Véase la lista completa de los criterios de exclusión en el protocolo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline (CFB) in the average number of micturition episodes per day
    - CFB in the average number of urgency episodes (urgency: need to urinate immediately) per day
    - Variación del número medio de episodios miccionales al día con respecto al basal
    - Variación del número medio de episodios de micción imperiosa (micción imperiosa: necesidad de orinar de inmediato) al día con respecto al basal
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 12
    en la semana 12
    E.5.2Secondary end point(s)
    - CFB in the average number of nocturia episodes per night
    - CFB in the average number of urge urinary incontinence episodes per day for subjects with urinary incontinence at baseline
    - CFB in the average of International Prostate Symptom Score (IPSS) Storage score (1-week
    recall)
    - CFB in the average volume voided per micturition
    - Variación del número medio de episodios de nicturia por noche con respecto al basal
    - Variación del número medio de episodios de incontinencia imperiosa urinaria al día con respecto al basal en los sujetos con incontinencia urinaria en la evaluación basal
    - Variación de la puntuación de Almacenamiento del Índice internacional de síntomas prostáticos (IPSS) con respecto al basal (memoria de una semana)
    - Variación del volumen medio evacuado por micción con respecto al basal
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 12
    en la semana 12
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tolerabilidad
    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 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 Yes
    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 EEA84
    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
    Canada
    Germany
    Hungary
    Lithuania
    Poland
    Portugal
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    Ultima Visita del Ultimo Paciente
    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 days25
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days25
    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: 725
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 363
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state47
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 348
    F.4.2.2In the whole clinical trial 1088
    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)
    Subjects who complete the study through the Week 24 Visit will return to standard of care or may be offered the opportunity to enroll in a 28-week extension study, described in a separate protocol (URO-901-3006), in which open-label vibegron will be provided.
    Los sujetos que concluyan el estudio hasta la Visita de la Semana 24 volverán a su tratamiento habitual o se les podrá ofrecer la opción de entrar en un estudio de extensión de 28 semanas, descrito en otro protocolo aparte (URO-901-3006), en el que se administrará vibegrón de manera abierta
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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