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    Summary
    EudraCT Number:2018-000768-27
    Sponsor's Protocol Code Number:IFX-1-P2.5
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-01-18
    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 number2018-000768-27
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA)
    Estudio en fase II aleatorizado, doble ciego, con doble simulación, con control activo, multicéntrico y de 2 partes sobre la sustitución de corticoesteroides por IFX-1 en la granulomatosis con poliangitis (GPA) y la poliangitis microscópica (PAM) activas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.
    Estudio de eficacia y seguridad de un anticuerpo monoclonal que reemplaza a los esteroides para el tratamiento de pacientes con granulomatosis con poliangitis (GPA) y la poliangitis microscópica (PAM).
    A.4.1Sponsor's protocol code numberIFX-1-P2.5
    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 SponsorInflaRx GmbH
    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 supportInflaRx GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInflaRx GmbH
    B.5.2Functional name of contact pointInflaRx GmbH
    B.5.3 Address:
    B.5.3.1Street AddressWinzerlaer Str. 2
    B.5.3.2Town/ cityJena
    B.5.3.3Post code07745
    B.5.3.4CountryGermany
    B.5.4Telephone number+349322754003111
    B.5.6E-mailinfo@inflarx.de
    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 nameIFX-1
    D.3.4Pharmaceutical form 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 INNnot yet available
    D.3.9.2Current sponsor codeIFX-1 (former code: CaCP29)
    D.3.9.3Other descriptive namechimeric monoclonal antibody, IgG4 subtype
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name PredniSONE Tablets, USP
    D.2.1.1.2Name of the Marketing Authorisation holderVintage Pharms
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameGlucocorticoids (GC)
    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 INNPREDNISONE
    D.3.9.1CAS number 53-03-2
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 10
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name GALEN® tablet
    D.2.1.1.2Name of the Marketing Authorisation holderGALENpharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGlucocorticoids (GC)
    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 INNPREDNISONE
    D.3.9.1CAS number 53-03-2
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 10
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
    Granulomatosis con poliangitis (GPA) y la poliangitis microscópica (PAM) activas
    E.1.1.1Medical condition in easily understood language
    GPA and MPA are severe rare diseases causing pain and swelling of blood vessels and other tissues.
    GPA y PAM son enfermedades raras y severas que causan dolor e hinchazón de los vasos sanguíneos y otros tejidos.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10063344
    E.1.2Term Microscopic polyangiitis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072579
    E.1.2Term Granulomatosis with polyangiitis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy of IFX-1 treatment as a replacement for glucocorticoids [GC] therapy in subjects with GPA and MPA.
    El objetivo principal es evaluar la eficacia del tratamiento con IFX-1 como sustitución del tratamiento con glucocorticoides (GC) en pacientes con GPA y PAM.
    E.2.2Secondary objectives of the trial
    •To assess safety and tolerability of IFX-1
    •To compare GC-induced toxicity of standard-dose GC and reduced dose GC with IFX-1 treatment
    •To generate data for PK and PD modelling of IFX-1 treatment.
    - Evaluar la seguridad y la tolerabilidad de IFX-1
    - Comparar la toxicidad inducida por GC de la dosis estándar de GC y de la dosis reducida de GC con el tratamiento con IFX-1
    - Generar datos para los modelos de farmacocinética (FC) y farmacodinámica (FD) del tratamiento con IFX-1.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, ≥ 18 years of age.
    2. Written informed consent obtained from subject.
    3. Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference (CHCC).
    4.History of positive antigen-specific ANCA testing since the time of diagnosis or at screening, or documented evidence of either anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) (for newly diagnosed subjects a recent positive antigen-specific ANCA testing is mandatory for inclusion)
    5. Have ≥ 1 “major” item, or ≥ 3 other items, or ≥ 2 renal items on the Birmingham Vasculitis Activity Score Version 3 (BVASv3).
    6. Newly diagnosed or relapsed GPA or MPA that requires treatment with CYC or RTX plus GCs.
    7. Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m².
    1. Hombre o mujer ≥ 18 años de edad.
    2. Consentimiento informado por escrito obtenido del sujeto.
    3. Diagnóstico de GPA o PAM, de acuerdo con las definiciones de la Conferencia de consenso de Chapel Hill (Chapel Hill Consensus Conference, CHCC).
    4. Antecedentes de resultado positivo en la prueba de anticuerpos anticitoplasma de neutrófilos (ANCA) específicos de antígeno desde el momento del diagnóstico o en el momento de la selección, o indicios documentados de anti-proteinasa 3 (anti-PR3) o anti mieloperoxidasa (anti-MPO) (para los sujetos de nuevo diagnóstico es obligatorio un resultado positivo reciente de la prueba de ANCA específicos de antígeno o positividad documentada de anti-PR3 o anti-MPO para la inclusión).
    5. Tener ≥ 1 ítems importantes, o ≥ 3 ítems mínimos, o ≥ 2 ítems renales en la puntuación de la actividad de la vasculitis de Birmingham, versión 3 (Birmingham Vasculitis Activity Score Version 3, BVASv3).
    6. GPA o PAM recién diagnosticada o recidivante que requiere tratamiento con CYC o RTX más GC.
    7. Tasa de filtración glomerular estimada (TFGe) ≥ 20 ml/min/1,73 m².
    E.4Principal exclusion criteria
    1. Any other multi-system autoimmune disease as listed in Appendix 18.4.
    2. Require mechanical ventilation because of alveolar hemorrhage at screening.
    3. Known hypersensitivity to any investigational medicinal product (IMP) (i.e. GC, IFX-1) and/or any excipients.
    4. Subject with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
    5. Have required management of infections, as follows:
    a. Chronic infection requiring anti-infective therapy (such as latent tuberculosis, pneumocystis, aspergillosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
    b. Use of intravenous antibacterials, antivirals, anti-fungals, or anti parasitic agents within 30 days of screening.
    6. Current and/or history (within the previous 5 years) of drug and/or alcohol abuse and/or dependence.
    7. Hepatitis B virus, (HBV) hepatitis C virus (HCV), or human immunodeficiency virus (HIV) viral test showing evidence of active or chronic viral infection at screening or a documented history of HIV, or an active or chronic hepatitis B or hepatitis C infection.
    8. Any of the following abnormal laboratory findings at screening:
    a. White blood cells < 3,500/mm3
    b. Platelet count < 100,000/mm3
    c. Transaminase values (AST and/or ALT) ≥ 2.5 times the upper limit of normal range (ULN)
    d. Total bilirubin ≥ 1.5 times ULN
    e. Alkaline Phosphatase (ALP) > 3 times ULN
    9. Current or history of malignancy, lymphoproliferative, or myeloproliferative disorder except squamous cell or basal cell carcinomas of the skin and cervical carcinoma in situ with curative surgical treatment.
    10. Received CYC or RTX within 12 weeks before screening; if on AZA, MMF or MPS or MTX at the time of screening, these drugs must be withdrawn prior to receiving the first dose of CYC or RTX.
    11. Received > 3 g cumulative intravenous GCs within 4 weeks before screening.
    12. Received an oral daily dose of a GC of > 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening.
    13. Received a CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept, alemtuzumab, any other experimental or biological therapy, intravenous immunoglobulin or plasma exchange, antithymocyte globulin, or required renal dialysis within 12 weeks before screening.
    14. Received a live vaccination within 4 weeks before screening or planned between screening and Week 24.
    15. Either active or latent tuberculosis treatment is ongoing.
    16. Pregnant or lactating.
    17. Clinically significant abnormal electrocardiogram (ECG) during screening.
    18. Female subjects of childbearing potential unwilling or unable to use a highly effective method of contraception (pearl index < 1%) during treatment and for at least 3 months after last administration of IFX- 1/Placebo-IFX-1 (or up to 12 months, the timeframes for Standard of Care agents have to be considered as described in the respective Prescribing Information/SPCstimeframes). Contraception methods regarded as highly effective methods and the duration of contraception are further described in Section 7.7.
    19. Evidence or suspicion that the subject might not comply with the requirements of the study protocol.
    20. The subject is an employee or direct relative of an employee of the sponsor (InflaRx GmbH).
    21. The subject is imprisoned or lawfully kept in an institution.
    22. The subject has participated in an investigational clinical study during the 12 weeks (or 5 times the half-life of the previous IMP, whichever is longer) before screening, or plans to participate in another investigational clinical study during their participation in this study.
    23.Male subjects with female partners of childbearing potential unwilling
    to use contraception (condoms) during treatment and for at least 3
    months after last administration of IFX-1/Placebo-IFX-1.
    1. Cualquier otra enfermedad autoinmunitaria multisistémica de las que se indican en el Apéndice.
    2. Requerir ventilación mecánica a causa de una hemorragia alveolar en la selección.
    3. Hipersensibilidad conocida a cualquier producto en investigación (PEI) (es decir, GC, IFX-1) y/o cualquiera de sus excipientes.
    4. Sujetos con problemas hereditarios raros de intolerancia a la galactosa, deficiencia total de lactasa o absorción inadecuada de la glucosa-galactosa.
    5. Haber requerido tratamiento para infecciones, como sigue:
    a. Infección crónica que requiera tratamiento antiinfeccioso (como tuberculosis latente, neumocistosis, aspergilosis, citomegalovirus, virus del herpes simple, herpes zóster y micobacterias atípicas).
    b. Uso de antibacterianos, antivirales, antimicóticos o antiparasitarios intravenosos en los 30 días previos a la selección.
    6. Uso actual y/o antecedentes (en los 5 años anteriores) de abuso y/o dependencia de drogas y/o alcohol.
    7. Prueba del virus de la hepatitis B (VHB), virus de la hepatitis C (VHC) o virus de la inmunodeficiencia humana (VIH) que muestre indicios de una infección vírica activa o crónica en la selección o antecedentes documentados de VIH o de una infección activa o crónica por el virus de la hepatitis B o la hepatitis C.
    8 Cualquiera de los siguientes resultados analíticos anómalos en la selección:
    a. Leucocitos < 3500/mm3
    b. Recuento de plaquetas <100 000/mm3
    c. Valores de transaminasas (AST y/o ALT) ≥ 2,5 veces el límite superior de la normalidad (LSN)
    d. Bilirrubina total ≥ 1,5 veces el LSN
    e. Fosfatasa alcalina (FA) > 3 veces el LSN
    9. Tener antecedentes de, o tener en la actualidad, neoplasia maligna, trastorno infoproliferativo o mieloproliferativo excepto carcinoma espinocelular o basocelular de la piel y carcinoma cervicouterino in situ con tratamiento quirúrgico curativo.
    10. Haber recibido CYC o RTX en las 12 semanas anteriores a la selección; si se está tratando con AZA, MMF o MPS o MTX en el momento de la selección, estos fármacos deben ser retirados antes de recibir la primera dosis de CYC o RTX.
    11. Haber recibido una dosis acumulada > 3 g de GC intravenosos en las 4 semanas anteriores a la selección.
    12. Haber recibido una dosis oral diaria > 10 mg de un GC equivalente a la prednisona durante más de 6 semanas de forma continua antes de la selección.
    13. Haber recibido un inhibidor de CD20, tratamiento con antagonistas del factor de necrosis tumoral, abatacept, alemtuzumab, cualquier otro tratamiento experimental o biológico, inmunoglobulina intravenosa o plasmaféresis, globulina antitimocítica, o necesitó diálisis renal en las 12 semanas anteriores a la selección.
    14. Haber recibido una vacuna viva en las 4 semanas anteriores a la selección o tener previsto recibirla entre la selección y la semana 24.
    15. El tratamiento para la tuberculosis activa o latente está en curso
    16. Paciente embarazada o en periodo de lactancia.
    17. Anomalía clínicamente significativa en el electrocardiograma (ECG) durante la selección.
    18. Pacientes en edad fértil que no puedan o no estén dispuestas a utilizar un método anticonceptivo altamente eficaz (índice de Pearl < 1 %) durante el tratamiento y durante al menos 3 meses después de la última administración de IFX-1/placebo-IFX-1 (o hasta 12 meses, se deben considerar los plazos de los agentes de la práctica clínica habitual como se describe en la respectiva ficha técnica/RCP). Los métodos anticonceptivos considerados altamente eficaces y la duración de la anticoncepción se describen con más detalle en la Sección 7.7.
    19. Indicios o sospecha de que el sujeto podría no cumplir con los requisitos del protocolo del estudio.
    20. El sujeto es un empleado o familiar directo de un empleado del promotor.
    21. El sujeto está preso o recluido en una institución por ley.
    22. El sujeto ha participado en un estudio clínico de investigación clínica en las 12 semanas (o 5 veces la semivida del PEI anterior, lo que sea más prolongado) anteriores a la selección, o tiene previsto participar en otro estudio de investigación clínica durante su participación en este estudio.
    23. Sujetos varones con parejas de sexo femenino en edad fértil que no estén dispuestas a utilizar un método anticonceptivo (preservativo) durante el tratamiento y durante al menos 3 meses después de la última administración de IFX-1/placebo-IFX-1.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects achieving clinical response defined as reduction in BVASv3 ≥ 50% at Week 16 compared to baseline and no worsening in any body system. Subjects who receive rescue therapy until Week 16 will be considered as not having achieved clinical response.
    El criterio de valoración principal es la proporción de pacientes que consiguen una respuesta clínica se define como una reducción en la BVASv3 ≥ 50 % en la semana 16 en comparación con el inicio y ningún empeoramiento en ningún sistema orgánico. Se considerará que no han alcanzado una respuesta clínica los sujetos que reciban tratamiento de rescate hasta la semana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    1.Proportion of subjects with clinical response, defined as reduction in BVASv3 ≥ 50% and no worsening in any body system at each measurement time point except Week 16. Subjects who receive rescue therapy will be considered as not having achieved clinical response at each time point later than the first administration of rescue therapy
    2.Proportion of subjects with a clinical remission defined as having a BVASv3 = 0 at Week 16
    3.Absolute values and absolute and relative change from Day 1 in the VDI at Week 16
    4.Absolute values and absolute and relative change from Day 1 in the PGA at Week 16
    5.Absolute values and absolute and relative change from Day 1 in eGFR in mL/min/1.73 m² at Week 16.
    1. Proporción de pacientes con una respuesta clínica, que se define como una reducción en la BVASv3 ≥ 50 % y ningún empeoramiento en ningún sistema orgánico en cada punto de medición, excepto el de la semana 16. Los sujetos que reciben terapia de rescate serán considerados como que no han logrado una respuesta clínica en cada momento posterior a la primera administración de la terapia de rescate.
    2. Proporción de sujetos con una remisión clínica, definida como tener una puntuación en la BVASv3 = 0 en la semana 16
    3. Valores absolutos y cambio absoluto y relativo desde el día 1 en el Índice de daño de vasculitis (Vasculitis Damage Index, VDI) en la semana 16
    4. Valores absolutos y cambio absoluto y relativo desde el día 1 en la Evaluación global por parte del médico (Physician Global Assessment, PGA) en la semana 16
    5. Valores absolutos y cambio absoluto y relativo desde el día 1 en la TFGe en ml/min/1,73 m² en la semana 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At weeks 0 (Day 1), 1, 2, 4, 8, 12, 20, 24
    2. Week 16
    3. 4. and 5. From Day 1 to week 16
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Belgium
    Czech Republic
    France
    Germany
    Ireland
    Italy
    Netherlands
    Russian Federation
    Spain
    Sweden
    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
    LVLS
    LVLP
    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 months0
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days15
    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: 57
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 81
    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)
    Patients will return to standard of care
    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 Decision2019-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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