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    Summary
    EudraCT Number:2019-003405-94
    Sponsor's Protocol Code Number:ABY-035-202
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-12-02
    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 number2019-003405-94
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, dose-finding clinical trial inpatients with active psoriatic arthritis to investigate efficacy, tolerability, safety,
    pharmacokinetics and immunogenicity of ABY-035
    Ensayo clínico multicéntrico, aleatorizado, doble ciego, controlado con placebo y de búsqueda de dosis en pacientes con artritis psoriásica activa para investigar la eficacia, la tolerabilidad, la seguridad, la farmacocinética y la inmunogenicidad de ABY-035
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind study in subjects with active psoriatic arthritis to evaluate efficacy, tolerability, safety of two different dose levels of ABY-035 compared to placebo.
    Estudio doble ciego en sujetos con artritis psoriásica activa para investigar la eficacia, la tolerabilidad, la seguridad de dos dosis con diferentes niveles de ABY-035 comparado con placebo
    A.4.1Sponsor's protocol code numberABY-035-202
    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 SponsorAffibody AB
    B.1.3.4CountrySweden
    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 supportAffibody AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAffibody AB
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressScheeles väg 2
    B.5.3.2Town/ citySolna
    B.5.3.3Post codeSE-171 65
    B.5.3.4CountrySweden
    B.5.4Telephone number+46 (0)763 49 58 49
    B.5.6E-mailcamilla.sandell@affibody.se
    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 nameABY-035
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 2226130-02-3
    D.3.9.2Current sponsor codeABY-035
    D.3.9.3Other descriptive nameRecombinant protein comprising two IL-17A binding domains and an albumin binding domain
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Psoriatic Arthritis
    artritis psoriásica activa
    E.1.1.1Medical condition in easily understood language
    Psoriatic Arthritis
    artritis psoriásica
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    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 efficacy of different dose regimens of ABY-035 as compared to placebo in patients with active psoriatic arthritis (PsA)
    Evaluar la eficacia de las diferentes pautas posológicas de ABY-035 en comparación con placebo en pacientes con artritis psoriásica activa (APs)
    E.2.2Secondary objectives of the trial
    To evaluate further efficacy, tolerability, safety, pharmacokinetics, immunogenicity and pharmacodynamics of two dose regimens of ABY-035
    Seguir evaluando la eficacia, la tolerabilidad, la seguridad, la farmacocinética, la inmunogenicidad y la farmacodinámica de dos pautas posológicas de ABY-035
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient who has given his / her signed declaration of consent and data protection declaration
    2. At least 18 years and less than 75 years of age at Screening visit
    3. Psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of ≥3 points from the five categories of the Classification Criteria for Psoriatic Arthritis (CASPAR) at any timepoint in medical history.
    4. Active psoriatic arthritis defined by:
    a. ≥3 swollen joints out of 66 joints (SJC66) at Screening visit and Baseline visit
    b. ≥3 tender joints out of 68 (TJC68) at Screening visit and Baseline visit
    5. Precedent failure or insufficient treatment response or contraindication or intolerability to nonsteroidal antiphlogistic drug (NSAID) and / or DMARD (at least a, b or c of the following must apply):
    a. NSAID
    b. csDMARD (i.e. MTX, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine A)
    c. TNFi (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab)
    6. Rheumatoid factor (RF) and anti-CCP antibody negative
    7. Presence or history of plaque psoriasis
    8. For females of childbearing potential only: Negative serum human chorionic gonadotropin (hCG) test at Screening visit
    9. Willingness and capability of using adequate contraceptive methods from the Screening visit until 4 weeks after the last ABY-035 dose:
    a. Female of childbearing should use a highly efficient method of contraception (see 9c) but this is not necessary for females of non-childbearing potential permanently sterilized or post-menopausal [i.e. at least 12 consecutive months with amenorrhea without other known or suspected medical cause])
    b. Male who has a female partner of childbearing potential, should use a highly efficient method of contraception (see 9c)
    c. Adequate contraceptive method defined as:
    i. A method with less than 1% failure rate (e.g. permanent sterilization, hormone
    implants, hormone injections, some intrauterine devices, or vasectomized partner)
    OR
    ii. The use of two methods of contraception (e.g. one barrier method [condom,
    diaphragm or cervical / vault caps] with spermicide and one hormonal contraceptive [e.g. combined oral contraceptives, patch, vaginal ring, injectables and implants])
    10. Willingness and capability of complying with all trial procedure requirements, as per the investigator’s judgement
    1.Paciente que ha entregado las declaraciones de consentimiento y de protección de datos firmadas
    2.Tener al menos 18 años y menos de 75 años en la visita de selección
    3.Artritis psoriásica con enfermedad musculoesquelética inflamatoria (articulación, columna vertebral o entesitis) con presencia de ≥3 puntos de las cinco categorías de los criterios de clasificación para la artritis psoriásica (CASPAR) en cualquier momento de la historia médica
    4.Artritis psoriásica activa definida por:
    a.≥3 articulaciones inflamadas de 66 articulaciones (SJC66) en la visita de selección y en la visita inicial;
    b.≥3 articulaciones dolorosas a la palpación de 68 articulaciones (TJC68) en la visita de selección y en la visita inicial.
    5.Fracaso anterior o respuesta insuficiente al tratamiento, contraindicación o intolerancia al fármaco antiinflamatorio no esteroideo (AINE) y/o FARME (debe aplicarse al menos a, b o c de las siguientes):
    a.AINE;
    b.FARMEsc (es decir, MTX, sulfasalazina, leflunomida, hidroxicloroquina, ciclosporina A);
    c.iTNF (p.ej., adalimumab, infliximab, etanercept, golimumab, certolizumab).
    6.Factor reumatoide (FR) y anticuerpos anti-PCC negativos.
    7.Presencia o antecedentes de psoriasis en placas.
    8.Solo para mujeres en edad fértil: prueba negativa de gonadotropina coriónica humana (GCH) en suero en la visita de selección.
    9.Disposición y capacidad de utilizar métodos anticonceptivos adecuados desde la visita de selección hasta 4 semanas después de la última dosis de ABY-035:
    a.Las mujeres en edad fértil deben utilizar un método anticonceptivo altamente eficaz (véase 9c), pero esto no es necesario para mujeres sin capacidad de concebir permanente esterilizadas o posmenopáusicas (es decir, al menos 12 meses consecutivos con amenorrea sin que se sospeche o se conozca otra causa).
    b.Los hombres que tengan una pareja femenina con capacidad de concebir deben utilizar un método anticonceptivo altamente eficaz (véase 9c).
    c.Método anticonceptivo adecuado definido como:
    i.un método con menos del 1 % de tasa de fracaso (p. ej., esterilización permanente, implantes hormonales, inyecciones hormonales, algunos dispositivos intrauterinos o pareja vasectomizada)
    O
    ii.uso de dos métodos anticonceptivos (por ejemplo, un método de barrera [preservativo, diafragma o capuchón/cubierta cervical] con espermicida y un anticonceptivo hormonal [p. ej., anticonceptivos orales combinados, parche, anillo vaginal, inyectables e implantes]).
    10.Disposición y capacidad de cumplir con todos los requisitos del procedimiento del ensayo, según el criterio del investigador.
    E.4Principal exclusion criteria
    Principal Exclusion criteria:
    1. Underlying conditions which, in the investigator’s opinion, significantly immunocompromise the patient and / or place the patient at unacceptable risk for receiving an immunomodulatory therapy
    2. History of or current relevant autoimmune diseases (e.g. rheumatoid arthritis, primary ankylosing spondylitis, systemic lupus erythematosus) other than psoriasis or psoriatic arthritis
    3. History of or current fibromyalgia or pain syndrome
    4. Uncontrolled inflammatory bowel disease
    5. Presence or history of recurrent or medically important infections in the last 6 months prior to Baseline visit, e.g. due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections, that required medical / pharmaceutical intervention (i.e. prescription of antibiotics and / or hospitalization)
    6. Clinically relevant Candida infection requiring systemic treatment within the last 6 months prior to Baseline visit
    7. History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years (with the exception of basal cell or squamous cell carcinoma of the skin that had been fully excised with no evidence of recurrence)
    8. Insufficiently controlled heart failure, as assessed by the investigator
    9. Current uncontrolled arterial hyper- or hypotension
    Laboratory examinations and body measurements:
    10. Positive test for subclinical / latent tuberculosis infection (i.e. positive QuantiFERON-TB® Gold test or equivalent product) or chest X-ray suggestive of tuberculosis at Screening visit
    11. Positive test for human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) at Screening visit:
    a. HIV antibody (any test)
    b. HBV surface antigen (HBVsAg)
    c. Anti-HCV antibody (HCV Ab)
    12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.5 times the upper limit of normal (ULN) at Screening visit
    13. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 according to the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation at Screening visit
    14. Body mass index (BMI) ≥40 kg/m2 or <16 kg/m2
    Medication, drug use and special behavioral patterns
    15. Previous exposure to ABY-035 or any other interleukin-(IL-)17i or IL-17 receptor inhibitor (e.g. secukinumab, ixekizumab, brodalumab)
    16. History of hypersensitivity or allergy to ABY-035 or its excipients
    Refer to Protocol for full list of Exclusion criteria
    Criterios de exclusion principals:
    1.Afecciones subyacentes que, en opinión del investigador, comprometen inmunológicamente de un modo significativo al paciente y/o ponen al paciente en riesgo inaceptable de recibir un tratamiento inmunomodulador.
    2.Antecedentes de enfermedades autoinmunitarias relevantes o actuales (p. ej., artritis reumatoide, espondilitis anquilosante primaria, lupus eritematoso sistémico) que no sea psoriasis o artritis psoriásica.
    3.Antecedentes de fibromialgia o síndrome del dolor actuales.
    4.Enfermedad inflamatoria intestinal no controlada.
    5.Presencia o antecedentes de infecciones recurrentes o médicamente importantes en los 6 meses anteriores a la visita inicial; por ejemplo, debido a infecciones bacterianas, micobacterianas, fúngicas invasivas, parasitarias, víricas u otras infecciones oportunistas, que requieren intervención médica/farmacéutica (es decir, prescripción de antibióticos y/u hospitalización).
    6.Infección por Candida clínicamente relevante que requiera tratamiento sistémico en los 6 meses anteriores a la visita inicial.
    7.Antecedentes o cualquier signo de enfermedad linfoproliferativa, o neoplasia maligna conocida o antecedentes de neoplasia maligna en los 5 años anteriores (excepto carcinoma basocelular o epidermoide de la piel que se había extirpado completamente sin evidencia de recurrencia).
    8.Insuficiencia cardíaca insuficientemente controlada, según la evaluación del investigador.
    9.Hipertensión o hipotensión arterial actual no controlada.
    Exploraciones analíticas y mediciones corporales
    10.Prueba positiva de infección por tuberculosis subclínica/latente (es decir, positivo para la prueba QuantiFERON-TB® Gold o producto equivalente) o radiografía de tórax indicativa de tuberculosis en la visita de selección
    11.Prueba positiva para el virus de la inmunodeficiencia humana (VIH), hepatitis B (VHB) o hepatitis C (VHC) en la visita de selección:
    a.Anticuerpos contra el VIH (cualquier prueba)
    b.Antígeno de superficie del VHB (AsVHB)
    c.Anticuerpos anti-VHC (Ac VHC)
    12.Nivel de alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) ≥2,5 veces el límite superior de la normalidad (LSN) en la visita de selección.
    13.Tasa de filtración glomerular estimada (TFGe) <60 ml/min/1,73 m2 de acuerdo con ecuación de la Colaboración epidemiológica para la enfermedad renal crónica (CKD-EPI) en la visita de selección.
    14.Índice de masa corporal (IMC) ≥40 kg/m2 o <16 kg/m2.
    Medicación, consumo de drogas y patrones de comportamiento especiales
    15.Exposición previa a ABY-035 o a cualquier otro inhibidor del receptor de la interleucina (IL-)17i o IL-17 (p. ej., secukinumab, ixekizumab, brodalumab).
    16.Antecedentes de hipersensibilidad o alergia a ABY-035 o a sus excipientes.
    Refierase al protocol para el listado completo de criterios de exclusión
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint Family (Efficacy):
    ● ACR50 response rate at V9 (Week 16) for Higher Dose (80 mg) vs Placebo
    ● ACR50 response rate at V7 (Week 12) for Higher Dose vs Placebo
    Familia de criterios de valoración principales (eficacia):
    •Tasa de respuesta de ACR50 en la V9 (semana 16) para dosis más altas (80 mg) frente a placebo
    •Tasa de respuesta de ACR50 en la V7 (semana 12) para dosis más altas frente a placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Endpoint Family (Efficacy) evaluation Timepoint:
    ● ACR50 response rate at V9 (Week 16) for Higher Dose (80 mg) vs Placebo
    ● ACR50 response rate at V7 (Week 12) for Higher Dose vs Placebo
    Tiempos para la familia de criterios de valoración (eficacia):
    •Tasa de respuesta de ACR50 en la V9 (semana 16) para dosis más altas (80 mg) frente a placebo
    •Tasa de respuesta de ACR50 en la V7 (semana 12) para dosis más altas frente a placebo
    E.5.2Secondary end point(s)
    Secondary Endpoint Family (Efficacy):
    ● ACR20/70 response rate at V9 (Week 16)
    ● ACR20/50/70 response rate at V5/V7/V13/FUEoT (Weeks 8/12/32/48)
    ● Proportion of patients achieving MDA at V9/V13/FUEoT (Weeks 16/32/48)
    Familia de criterios de valoración secundarios (eficacia):
    •Tasa de respuesta de ACR20/70 en la V9 (semana 16)
    •Tasa de respuesta de ACR20/50/70 en la V5/V7/V13/SEGFdT (semanas 8/12/32/48)
    •Proporción de pacientes que alcanzaron la AME en V9/V13/SEGFdT (semanas 16/32/48)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoint Family (Efficacy):
    ● ACR20/70 response rate at V9 (Week 16)
    ● ACR20/50/70 response rate at V5/V7/V13/FUEoT (Weeks 8/12/32/48)
    ● Proportion of patients achieving MDA at V9/V13/FUEoT (Weeks 16/32/48)
    Tiempos para la familia de criterios de valoración secundarios (eficacia):
    •Tasa de respuesta de ACR20/70 en la V9 (semana 16)
    •Tasa de respuesta de ACR20/50/70 en la V5/V7/V13/SEGFdT (semanas 8/12/32/48)
    •Proporción de pacientes que alcanzaron la AME en V9/V13/SEGFdT (semanas 16/32/48)
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    immunogenicity of ABY-035
    immunogenicidad de ABY-035
    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 Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    última visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months25
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months25
    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: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 129
    F.4.2.2In the whole clinical trial 129
    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)
    The choice of further therapy for PsA at the end of the clinical trial depends on the patient's individual
    needs and is left at the physician's discretion.
    La elección de una terapia adicional para la APs al final del ensayo clínico dependerá de las necesidades individuales de cada paciente y se deja a discreción del medico.
    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 Decision2020-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-20
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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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