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    Summary
    EudraCT Number:2020-005054-19
    Sponsor's Protocol Code Number:MOR202C206
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-09
    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 number2020-005054-19
    A.3Full title of the trial
    A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ
    Ensayo clínico fase IIa, multicéntrico, doble ciego, aleatorizado, controlado con placebo para evaluar la eficacia y seguridad del anticuerpo humano anti-CD38 Felzartamab en nefropatía por IgA- IGNAZ
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess efficacy and safety of the human Anti-CD38 Antibody Felzartamab in IgA Nephropathy
    Ensayo clínico para evaluar la eficacia y seguridad del anticuerpo humano Anti-CD38 Felzartamab in nefropatía por IgA
    A.4.1Sponsor's protocol code numberMOR202C206
    A.5.4Other Identifiers
    Name:INDNumber:142840
    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 SponsorMorphoSys AG
    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 supportMorphoSys AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMorphoSys AG
    B.5.2Functional name of contact pointGlobal Program Medical Director
    B.5.3 Address:
    B.5.3.1Street AddressSemmelweisstrasse 7
    B.5.3.2Town/ cityPlanegg
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    B.5.4Telephone number+34900834223
    B.5.5Fax number+498989927 526640
    B.5.6E-mailRegistroEspanolDeEstudiosclinicos@druginfo.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 nameFelzartamab
    D.3.2Product code MOR202
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFelzartamab
    D.3.9.1CAS number 2197112-39-1
    D.3.9.2Current sponsor codeMOR202
    D.3.9.3Other descriptive nameMOR03087
    D.3.9.4EV Substance CodeSUB32212
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number65
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal anti-CD38 antibody
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    IgA Nephropathy (IgAN)
    Nefropatía IgA (NIgA)
    E.1.1.1Medical condition in easily understood language
    Autoimmune kidney diseases IgA nephropathy
    Enfermedad renal autoinmune de nefropatía IgA
    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 23.1
    E.1.2Level PT
    E.1.2Classification code 10084204
    E.1.2Term Sickle cell nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of Felzartamab compared to placebo in patients with IgAN based on the change in urine protein to creatinine ratio (UPCR) at 9 months.
    Evaluar la eficacia de felzartamab en comparación con placebo en pacientes con NIgA basándose en el cambio en el cociente proteínas/creatinina en orina (CPCO) a los 9 meses
    E.2.2Secondary objectives of the trial
    To assess the relationship between exposure, safety, and efficacy in each of the three dose groups vs. placebo to support a decision for a dose in further trials
    To assess the efficacy of Felzartamab compared to placebo in patients with IgAN based on the following:
    - Change in UPCR at 3, 6, 12, 18 and 24 months
    - Complete response (CR) at 3, 6, 9, 12, 18 and 24 months
    - Proportion of patients with response at 3, 6, 9, 12, 18 and 24 months
    - Albumin-creatinine ratio (ACR) at 6, 9, 12, 18 and 24 months
    - Duration of response
    - Time to response
    To assess the renal function of Felzartamab compared to placebo in patients with IgAN.
    To assess the safety of Felzartamab in patients with IgAN.
    To assess the pharmacokinetic (PK) profile of Felzartamab in patients with IgAN.
    To investigate the potential immunogenicity of Felzartamab in patients with IgAN
    Evaluar la relación entre la exposición, la seguridad y la eficacia en cada uno de los tres grupos de dosis frente a placebo para respaldar una decisión respecto a la dosis en ensayos posteriores.
    Evaluar la eficacia de felzartamab en comparación con placebo en pacientes con NIgA según lo siguiente:
    o Cambio en el CPCO a los 3, 6, 12, 18 y 24 meses.
    o Respuesta completa (RC) a los 3, 6, 9, 12, 18 y 24 meses.
    o Proporción de pacientes con respuesta a los 3, 6, 9, 12, 18 y 24 meses.
    o Cociente albúmina/creatinina (ACR) a los 6, 9, 12, 18 y 24 meses.
    o Duración de la respuesta
    o Tiempo hasta la respuesta
    Evaluar la función renal de felzartamab en comparación con placebo en pacientes con NIgA.
    Evaluar la seguridad de felzartamab en pacientes con NIgA.
    Evaluar el perfil farmacocinético (FC) de felzartamab en pacientes con NIgA.
    Investigar la posible inmunogenicidad de felzartamab en pacientes con NIgA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]), but at least
    of legal age in the given country
    2. Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF
    3. Proteinuria at screening visit ≥ 1.0 g/d
    4. Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for ≥ 3 months prior to date of informed consent and adequate blood pressure (BP) control (recommended BP is < 125 mm Hg systolic and < 75 mm Hg diastolic).
    In case a patient is intolerant to even a very low dose of either ACEi or ARB therapy, approval for participation in the trial has to be obtained from the Medical Monitor prior to randomization.
    5. A female of childbearing potential (FCBP) is only eligible to participate if she is not pregnant, not breast feeding, and agrees to follow the contraceptive guidance 5 during the treatment period and for at least 3 months after the last dose of Felzartamab.
    1. Pacientes de ≥18 a ≤80 años (en la fecha de la firma del formulario de consentimiento informado [FCI]), pero al menos de edad legal en el país dado.
    2. Diagnóstico confirmado mediante biopsia de NIgA en los 8 años anteriores a la firma del FCI.
    3. Proteinuria en la visita de selección ≥1,0 g/d.
    4. Tratamiento con un inhibidor de la enzima convertidora de angiotensina (IECA) y/o bloqueador del receptor de angiotensina (BRA) a dosis máximas o dosis máximas toleradas durante ≥3 meses antes de la fecha del consentimiento informado y control adecuado de la presión arterial (PA) (la PA recomendada es <125 mm Hg sistólica y <75 mm Hg diastólica).
    En caso de que un paciente sea intolerante a una dosis muy baja de tratamiento con IECA o BRA, debe obtenerse la aprobación para participar en el ensayo del monitor médico antes de la aleatorización.
    5. Una mujer con capacidad de concebir (MCC), definida en el Anexo 5) solo es apta para participar si no está embarazada, no está en periodo de lactancia y está de acuerdo en seguir las directrices anticonceptivas del Anexo 5 durante el periodo de tratamiento y durante al menos 3 meses después de la última dosis de felzartamab.
    E.4Principal exclusion criteria
    1. Secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits (e.g. Lupus nephritis, Schönlein-Henoch purpura, ankylosing spondylitis, dermatitis herpetiformis, chronic liver disease, inflammatory bowel disease, celiac disease).
    2. Severe renal impairment as defined by estimated GFR < 30 mL/min (using chronic kidney
    disease-epidemiology collaboration [CKD-EPI] formula) or the need for dialysis or renal transplant.
    3. Rapidly progressive variant of IgAN, defined as eGFR loss by more than 30% per 3 months and not explained by changes in renin angiotensin system (RAS) blockade.
    4. Minimal change variant of IgAN.
    5. Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.
    6. Systemic immunosuppression (e.g. mycophenolate mofetil [MMF], cyclophosphamide, biologics like rituximab [RTX]), in particular corticosteroid therapy exceeding 20 mg/day prednisone-equivalent for more than 7 consecutive days within 180 days prior to signing ICF.
    7. Any previous treatment with an anti-CD38 antibody.
    8. Body mass index (BMI) > 35 kg/m^2.
    9. Hemoglobin < 80 g/L.
    10. Thrombocytopenia: Platelets < 100.0 x 10^9/L.
    11. Neutropenia: Neutrophils < 1.5 x 10^9/L.
    12. Leukopenia: Leukocytes < 3.0 x 10^9/L.
    13. Diabetes mellitus type 1.
    14. Diabetes mellitus type 2: Patients with type 2 diabetes mellitus may only enter the clinical trial if a kidney biopsy performed within 6 months prior to signing ICF shows IgAN without evidence of diabetic nephropathy and their disease is controlled, such as:
    a. Glycated hemoglobin (HbA1c) < 8.0% or < 64 mmoL/mol.
    b. No diabetic retinopathy known.
    c. No peripheral neuropathy known.
    15. Significant uncontrolled cardiovascular disease (including arterial or venous thrombotic or embolic events) or cardiac insufficiency (New York Heart Association [NYHA] class IV) as judged by the investigator.
    16. Clinically significant findings on a 12-lead electrocardiogram (ECG) as determined by the investigator at screening.
    17. History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity ≥ grade 3.
    18. Aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN.
    19. Known or suspected hypersensitivity to Felzartamab and its excipients (L-histidine, sucrose, polysorbate 20).
    20. Serologic markers positive for HIV or history of HIV, hepatitis C (patients with positive anti-hepatitis C virus [anti-HCV] antibody but negative HCV RNA polymerase chain reaction [PCR] can enroll) or active or latent hepatitis B (patients with positive hepatitis B surface antigen [HBsAg] are excluded). For patients with positive hepatitis B core antibody [anti-HBc], hepatitis B virus (HBV) DNA test by PCR must be non-detectable to enroll).
    21. Any malignancy within 5 years prior to screening start, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or other non-melanomatous skin cancer.
    22. Treatment within 5 terminal half-lives (if known) or within the last 30 days prior to Visit 2, whatever is longer) with investigational drugs.
    23. Any active infection (viral, fungal, bacterial) requiring systemic therapy.
    1. Formas secundarias de NIgA, indicadas por la presencia de cualquier otra enfermedad sistémica que pueda provocar depósitos de IgA (p. ej., nefritis lúpica, púrpura de Schönlein-Henoch, espondilitis anquilosante, dermatitis herpetiforme, hepatopatía crónica, enfermedad inflamatoria intestinal, enfermedad celíaca).
    2. Insuficiencia renal grave definida por una TFG estimada <30 ml/min (utilizando la fórmula de colaboración epidemiológica de la enfermedad renal crónica [Chronic Kidney Disease-Epidemiology Collaboration, CKD-EPI], véase la Sección 9.2 o la necesidad de diálisis o trasplante renal.
    3. Variante de progresión rápida de la NIgA, definida como pérdida de la TFGe en más del 30 % por cada 3 meses y que no se explica por los cambios en el bloqueo del sistema de renina angiotensina (RAS).
    4. Variante de cambios mínimos de la NIgA.
    5. Otra glomerulonefritis progresiva o enfermedad glomerular no inmunológica, como nefropatía diabética, concomitante.
    6. Inmunodepresión sistémica (p. ej., micofenolato mofetilo [MMF], ciclofosfamida, productos biológicos similares a rituximab [RTX]), en particular tratamiento con corticoesteroides que exceda los 20 mg/día de equivalente de prednisona (véase el apéndice 8) durante más de 7 días consecutivos en los 180 días anteriores a la firma del FCI.
    7. Cualquier tratamiento previo con un anticuerpo anti-CD38.
    8. Índice de masa corporal (IMC) >35 kg/m2.
    9. Hemoglobina <80 g/dl.
    10. Trombocitopenia: Plaquetas <100,0 x 109/l.
    11. Neutropenia: Neutrófilos <1,5 x 109/l.
    12. Leucopenia: Leucocitos <3,0 x 109/l.
    13. Diabetes mellitus tipo 1.
    14. Diabetes mellitus tipo 2: Los pacientes con diabetes mellitus tipo 2 solo pueden entrar en el ensayo clínico si una biopsia renal realizada en los 6 meses anteriores al FCI muestra una NIgA sin indicios de nefropatía diabética y su enfermedad está controlada, como:
    a. Hemoglobina glucosilada (HbA1c) <8,0 % o <64 mmol/mol.
    b. Sin retinopatía diabética conocida.
    c. Sin neuropatía periférica conocida.
    15. Enfermedad cardiovascular no controlada significativa (incluidos acontecimientos trombóticos o embólicos arteriales o venosos) o insuficiencia cardíaca (clase IV de la Asociación de Cardiología de Nueva York [New York Heart Association, NYHA]) según el criterio del investigador.
    16. Anomalías de importancia clínica en el electrocardiograma (ECG) de 12 derivaciones en la selección determinadas por el investigador.
    17. Antecedentes de enfermedad cerebrovascular significativa o neuropatía sensitiva o motora de toxicidad de grado ≥3.
    18. Aspartato aminotransferasa o alanina aminotransferasa >1,5 x LSN, fosfatasa alcalina >3,0 x LSN.
    19. Hipersensibilidad conocida o sospechada a felzartamab y sus excipientes (L-histidina, sacarosa, polisorbato 20).
    20. Marcadores serológicos positivos para VIH o antecedentes de VIH, hepatitis C (los pacientes con resultado positivo en anticuerpos contra el virus de la hepatitis C [anti-VHC] pero resultado negativo en la reacción en cadena de la polimerasa [PCR] de ARN del VHC pueden ser incluidos) o hepatitis B activa o latente (quedan excluidos los pacientes con antígeno de superficie de la hepatitis B [HBsAg] positivo). Para incluir a los pacientes con resultado positivo en anticuerpos nucleares contra la hepatitis B [anti-HBc], la prueba de ADN del virus de la hepatitis B (VHB) mediante PCR debe ser no detectable.
    21. Cualquier neoplasia maligna en los 5 años anteriores al inicio de la selección, con la excepción de carcinoma in situ del cuello uterino, carcinoma basocelular o escamocelular u otro cáncer de piel no melanomatoso tratado de manera adecuada.
    22. Tratamiento en 5 semividas terminales (si se conoce) o en los 30 días anteriores a la visita 2, lo que sea más prolongado) con fármacos en investigación.
    23. Cualquier infección activa (vírica, fúngica, bacteriana) que requiera tratamiento sistémico.
    E.5 End points
    E.5.1Primary end point(s)
    Relative change in UPCR in 24h urine compared to the reference proteinuria value in the Felzartamab dose groups vs. placebo.
    Cambio relativo en el CPCO en la orina de 24 h a los 9 meses en comparación con el valor de proteinuria de referencia en los grupos de dosis de felzartamab frente a placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 months
    9 meses
    E.5.2Secondary end point(s)
    Integrative analysis of several endpoints.
    Relative change in UPCR in 24h urine compared to the reference proteinuria value in each Felzartamab dose group vs. placebo.
    Complete response in each Felzartamab dose group vs. placebo.
    Proportion of patients with response in each Felzartamab dose group vs. placebo.
    Albumin-creatinine ratio from 24 h urine in each Felzartamab dose group vs. placebo.
    Duration of response in each Felzartamab dose group vs. placebo.
    Time to response in each Felzartamab dose group vs. placebo.
    Renal function (determined by estimated glomerular filtration rate [eGFR] over time) in each Felzartamab dose group vs. placebo.
    Frequency, incidence, seriousness, relatedness, and severity of treatment-emergent adverse events (TEAEs) across all treatment groups.
    Serum concentrations of Felzartamab over time in each Felzartamab dose group.
    Formation of anti-drug antibodies (ADAs) over time in all groups
    Análisis integrativo de varios criterios de valoración
    • Cambio relativo en el CPCO en orina en comparación con el valor de proteinuria de referencia en cada grupo de dosis de felzartamab frente a placebo.
    • Respuesta Completa en cada grupo de dosis de felzartamab frente a placebo.
    • Proporción de pacientes con respuesta en cada grupo de dosis de felzartamab frente a placebo.
    • ACR en orina de 24 horas en cada grupo de dosis de felzartamab frente a placebo.
    • Duración de la respuesta en cada grupo de dosis de felzartamab frente a placebo.
    • Tiempo hasta la respuesta en cada grupo de dosis de felzartamab frente a placebo.
    • Función renal (determinada por la tasa de filtración glomerular estimada [TFGe] a lo largo del tiempo) en cada grupo de dosis de felzartamab frente a placebo.
    • Frecuencia, incidencia, gravedad, relación e intensidad de los acontecimientos adversos surgidos durante el tratamiento (AAST) en todos los grupos de tratamiento.
    • Concentraciones séricas de felzartamab a lo largo del tiempo en cada grupo de dosis de felzartamab.
    • Formación de anticuerpos antifármaco (AAF) a lo largo del tiempo en todos los grupos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis will be performed after all randomized patients have completed their 9 month-visit or discontinued the trial earlier. The final analysis of all endpoints will be performed after all randomized patients have completed their last visit, or discontinued the trial earlier.
    The secondary endpoints will be assessed at 3, 6, 9, 12, 18, 24 months as defined per each in study protocol.
    El análisis primario se realizara después de que todos los pacientes randomizados hayan completado la visita a los 9 meses or hayan descontinuado el estudio antes. El análisis final de todos los objetivos se realizara después de que todos los pacientes randomizados hayan completado la ultima visita o hayan descontinuado el estudio antes. Los objetivos secundarios se evaluaran a los 3,6,9,12,18 y 24 meses según se define en el protocolo.
    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 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 EEA45
    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
    Australia
    Canada
    Georgia
    Japan
    Korea, Republic of
    Malaysia
    Philippines
    Serbia
    Taiwan
    Ukraine
    United States
    Belgium
    Bulgaria
    Germany
    Spain
    United Kingdom
    Czechia
    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
    LVLS
    Ultima visita ultimo paciente
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 44
    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)
    Best standard of care at investigator's discretion
    Mejor tratamiento disponible según el investigador
    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 Decision2021-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-30
    P. End of Trial
    P.End of Trial StatusOngoing
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