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    Summary
    EudraCT Number:2021-001426-22
    Sponsor's Protocol Code Number:ALXN2050-NEPH-201
    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:2022-05-12
    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 number2021-001426-22
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants with Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
    Estudio de fase II, aleatorizado, doble ciego y controlado con placebo de búsqueda de dosis para evaluar la eficacia y la seguridad de ALXN2050 en participantes adultos con nefritis lúpica (NL) proliferativa o nefropatía por inmunoglobulina A (NIgA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of ALXN2050 in Proliferative Lupus Nephretis (LN) and Immunoglobulin A Nephropathy (IgAN)
    Estudio de ALXN2050 en nefritis lúpica (NL) proliferativa o nefropatía por inmunoglobulina A (NIgA)
    A.4.1Sponsor's protocol code numberALXN2050-NEPH-201
    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 SponsorAlexion Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportAlexion Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlexion Europe SAS
    B.5.2Functional name of contact pointEuropean Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address103-105 Rue Anatole France
    B.5.3.2Town/ cityLevallois-Perret
    B.5.3.3Post code92300
    B.5.3.4CountryFrance
    B.5.4Telephone number00 34932723019
    B.5.6E-mailclinicaltrials.eu@alexion.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 nameALXN2050
    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 INNN/A
    D.3.9.1CAS number 2086178-00-7
    D.3.9.2Current sponsor codeALXN2050
    D.3.9.4EV Substance CodeSUB204167
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    Lupus Nephritis (LN)
    Immunoglobulin A Nephropathy (IgAN)
    Nefritis lúpica (NL)
    Nefropatía por inmunoglobulina A (NIgA)
    E.1.1.1Medical condition in easily understood language
    Lupus Nephritis (LN)
    Immunoglobulin A Nephropathy (IgAN)
    Nefritis lúpica (NL)
    Nefropatía por inmunoglobulina A (NIgA)
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021263
    E.1.2Term IgA 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 evaluate the efficacy of ALXN2050 to reduce proteinuria in participants with LN or IgAN
    Evaluar la eficacia de ALXN2050 para reducir la proteinuria en participantes con NL o NIgA.
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of ALXN2050 to improve measures of kidney function in participants with LN or IgAN
    • PK/PD - To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of ALXN2050 in participants with LN or IgAN
    • Safety -To characterize the safety and tolerability of ALXN2050 in participants with LN or IgAN

    LN Cohort only:
    •To evaluate the efficacy of ALXN2050 on measures of kidney function in participants with LN

    IgAN Cohort Only:
    •To evaluate the efficacy of ALXN2050 on measures of kidney function in participants with IgAN
    •Evaluar la eficacia de ALXN2050 para mejorar las mediciones de la función renal en participantes con NL o NIgA.
    •FC/FD- Caracterizar la farmacocinética (FC) y la farmacodinámica (FD) de ALXN2050 en participantes con NL o NIgA.
    •Seguridad- Caracterizar la seguridad y la tolerabilidad de ALXN2050 en participantes con NL o NIgA.

    Solo cohorte de NL
    •Evaluar la eficacia de ALXN2050 sobre las mediciones de la función renal en participantes con NL.

    Solo cohorte de NIgA
    •Evaluar la eficacia de ALXN2050 sobre las mediciones de la función renal en participantes con NIgA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    LN Cohort
    • Clinical diagnosis of SLE by 2019 American College of Rheumatology and European League Against Rheumatism criteria.
    • Diagnosis of 2018 Revised International Society of Nephrology/Renal Pathology Society classification (active focal or diffuse proliferative LN Class III or IV) confirmed by biopsy obtained ≤ 6 months prior to Screening or during Screening Period. Participants may co-exhibit Class V disease. Participants with de novo or relapsing disease may be eligible.
    • Clinically active LN at Screening requiring/receiving immunosuppression induction treatment in the opinion of the Investigator.
    • Proteinuria with UPCR ≥ 1 g/g based on one 24 hour urine collection during the Screening Period.

    IgAN Cohort
    • Established diagnosis of primary IgAN based on kidney biopsy obtained any time prior to or during the Screening Period.
    • Mean proteinuria ≥ 1 g/day on 2 complete and valid 24 hour urine collections during the Screening Period.
    • Presence of hematuria as defined by 1+ blood based on urine dipstick or ≥ 10 red blood cells/high power field microscopy on urine sediment (performed by the local laboratory) during Screening Period (only applicable if diagnostic biopsy is >2 years prior to Screening).
    • Compliance with stable and optimal dose of RAS inhibitor treatment including maximum allowed or tolerated angiotensin converting enzyme inhibitor and/or angiotensin receptor blocker dose for ≥ 3 months prior to Screening with no expected change in dose during the study (participants with established intolerance to RAS inhibitors may be included).
    • Controlled and stable blood pressure (defined as < 140/90 millimeters of mercury [mmHg]) over the past 3 months prior to randomization.
    Cohorte de nefritis lúpica (NL)
    • Diagnóstico clínico de lupus eritematoso sistémico (LES) según los criterios del Colegio Estadounidense de Reumatología de 2019 y la Liga Europea contra el Reumatismo.
    • Diagnóstico de la clasificación revisada por la Sociedad Internacional de Nefrología y la Sociedad de Patología Renal en 2018 (NL proliferativa focal o difusa activa de clase III o IV) confirmado mediante biopsia obtenida ≤6 meses antes o durante el periodo de selección. Los participantes pueden presentar también enfermedad de clase V. Los participantes con enfermedad de nueva aparición o recidivante pueden ser aptos.
    • NL clínicamente activa en la selección para la que, en opinión del investigador, se requiera o se reciba tratamiento de inducción de inmunosupresión.
    • Proteinuria con un cociente proteína/creatinina en orina (CPCo) ≥1 g/g basado en una recogida de orina de 24 horas durante el periodo de selección.
    Cohorte de NIgA
    • Diagnóstico definitivo de NIgA primaria basado en una biopsia renal obtenida en cualquier momento antes o durante el periodo de selección.
    • Proteinuria media ≥1 g/día en dos recogidas de orina de 24 horas completas y válidas obtenidas durante el periodo de selección.
    • Presencia de hematuria definida como 1+ de sangre en tira reactiva de orina o ≥10 eritrocitos por campo de gran aumento en estudio microscópico del sedimento urinario (realizado por el laboratorio local) durante el periodo de selección (solo procede si la biopsia diagnóstica es de >2 años antes de la selección).
    • Cumplimiento con la dosis estable y óptima del tratamiento con inhibidores del sistema renina-angiotensina SRA, incluida la dosis máxima permitida o tolerada de inhibidores de la enzima convertidora de angiotensina o de bloqueador del receptor de angiotensina durante ≥3 meses antes de la selección, sin cambio previsto en la dosis durante el estudio (pueden incluirse participantes con intolerancia confirmada a los inhibidores del SRA).
    • Mantener una presión arterial controlada y estable (definida como <140/90 milímetros de mercurio [mmHg]) durante los últimos 3 meses antes de la aleatorización.
    E.4Principal exclusion criteria
    Both Cohorts:
    • eGFR ≤ 30 milliliters/minute/1.73 squared meters during Screening calculated by Chronic Kidney Disease Epidemiology Collaboration.
    • More than or equal to 50% interstitial fibrosis, tubular atrophy, glomerular sclerosis, or crescent formation in glomeruli on most recent kidney biopsy prior or during the Screening Period.
    • Concomitant significant renal disease other than LN or IgAN on the most recent biopsy prior to or during the Screening Period.
    • History of solid organ or bone marrow transplant, or planned transplant during the Extended Treatment Period (50 weeks).
    • Splenectomy or functional asplenia.
    • Known or suspected complement deficiency, unless attributable to underlying disease (that is, LN and IgAN).
    • Bone marrow insufficiency with absolute neutrophil count < 1.3 × 10^3/microliter; thrombocytopenia (platelet count < 50,000/cubic millimeter).

    For LN Cohort:
    • Participants who have received any of the following treatments:
    a. Cyclophosphamide ≤ 6 months prior to Screening
    b. Calcineurin inhibitors ≤ 3 months prior to Screening
    c. A cumulative dose of intravenous methylprednisolone > 3 g for the current active renal flare
    d. Mycophenolate mofetil > 2 g/day (or equivalent) for ≥ 4 consecutive weeks prior to Screening for the current active renal flare
    e. Prednisone or prednisone equivalent ≥ 0.5 mg/kilogram/day for ≥ 4 consecutive weeks prior to Screening for the current active renal flare
    • Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 110 mmHg) on 2 or more measurements during the Screening Period.

    For IgAN Cohort:
    • Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 30% over a period of 3 months prior to or during the Screening Period.
    • Secondary etiologies of IgAN.
    • Prednisone or prednisone equivalent > 20 mg for > 14 consecutive days or any other immunosuppression within 6 months prior to Screening.
    • Blood pressure of ≥ 140/90 mmHg during the Screening Period confirmed on 2 measures > 30 minutes apart.
    Ambas cohortes:
    • TFGe ≤30 ml/min/1,73 m² durante la selección calculada mediante la fórmula de la Colaboración Epidemiológica para la Enfermedad Renal Crónica.
    • Fibrosis intersticial, atrofia tubular, esclerosis glomerular o formación de semilunas glomerulares superior o igual al 50 % en la biopsia renal más reciente realizada antes o durante el periodo de selección.
    • Enfermedad renal concomitante importante distinta de NL o NIgA en la biopsia más reciente realizada antes o durante el periodo de selección.
    • Antecedentes de trasplante de vísceras macizas o de médula ósea, o trasplante programado durante el periodo de tratamiento ampliado (50 semanas).
    • Esplenectomía o asplenia funcional.
    • Deficiencia de complemento conocida o sospechada, a menos que sea atribuible a la enfermedad subyacente (es decir, NL e NIgA).
    • Insuficiencia medular con recuento absoluto de neutrófilos <1,3 × 10^3/μl; trombocitopenia (recuento plaquetario <50 000/mm³).
    En la cohorte LN:
    • Participantes que hayan recibido alguno de los siguientes tratamientos:
    a. Ciclofosfamida ≤6 meses antes de la selección.
    b. Inhibidores de la calcineurina ≤3 meses antes de la selección.
    c. Dosis acumulada de metilprednisolona intravenosa >3 g para la exacerbación renal activa actual.
    d. Micofenolato de mofetilo >2 g/día (o equivalente) durante ≥4 semanas consecutivas antes de la selección para la exacerbación renal activa actual.
    e. Prednisona o equivalente ≥0,5 mg/kg/día durante ≥4 semanas consecutivas antes de la selección para la exacerbación renal activa actual.
    • Hipertensión no controlada (presión arterial sistólica >160 mmHg o presión arterial diastólica >110 mmHg) en 2 o más mediciones durante el periodo de selección.
    En la cohorte de NIgA:
    • Diagnóstico de glomerulonefritis progresiva rápida medida por la pérdida de TFGe ≥30 % durante un periodo de 3 meses antes o durante el periodo de selección.
    • Etiologías secundarias de la NIgA.
    • Prednisona o equivalente >20 mg durante >14 días consecutivos o cualquier otro inmunosupresor en los 6 meses anteriores a la selección.
    • Presión arterial ≥140/90 mmHg durante el periodo de selección confirmada en 2 mediciones con >30 minutos de diferencia.
    E.5 End points
    E.5.1Primary end point(s)
    1) Percentage change in proteinuria
    1) Variación porcentual en proteinuria
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Week 26 (based on 24-hour urine collection[s])
    1) semana 26 (basado en la[s] recogida[s] de orina de 24 horas).
    E.5.2Secondary end point(s)
    1) Percentage change in proteinuria
    2) Achieving > 30% and > 50% reduction in proteinuria
    3)Change from baseline in eGFR
    4)PK/PD - Observed plasma concentrations of ALXN2050
    5)PK/PD - Absolute values and change from baseline in plasma Bb concentration and serum AP activity

    LN Cohort Only:

    6) Meeting the criteria for complete renal response (CRR)
    7) Meeting the criteria for partial renal response (PRR)
    8) Time to the first occurrence of UPCR ≤ 0.5 g/g as measured by spot urine sample
    9) Achieving corticosteroid taper to 7.5 mg/day
    10) Experience of a Renal Flare
    11) Experience of an Extrarenal systemic lupus erythematosus (SLE) Flare
    12) Meeting the criteria for treatment failure
    13) Absolute values and change from baseline in serum albumin

    IgAN Cohort Only:
    14) Meeting the criteria for partial remission
    1) Variación porcentual en proteinuria
    2) Consecución de una reducción de los niveles de proteinuria >30 % y >50 %
    3) Variación con respecto al inicio en la TFGe
    4) FC/FD- Observación de las concentraciones plasmáticas de ALXN2050
    5)FC/FD- Valores absolutos y variación con respecto al inicio en la concentración de Bb en plasma y en la actividad de la VA en suero

    solo cohorte de NL
    6) Cumplir los criterios de respuesta renal completa (RRC)
    7) Cumplir los criterios de respuesta renal parcial (RRP)
    8) Tiempo transcurrido hasta la primera aparición de un CPCO ≤0,5 g/g medido en una muestra puntual de orina.
    9) Consecución de una disminución gradual de la administración de corticoesteroides hasta 7,5 mg/día
    10) Presentar una exacerbación renal
    11) Presentar una exacerbación del lupus eritematoso sistémico (LES) extrarrenal
    12) Cumplir los criterios de fracaso terapéutico
    13) Valores absolutos y variación con respecto al inicio en los niveles de albúmina sérica

    solo cohorte de NIgA
    14) Cumplir los criterios de remisión parcial
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12, Week 26, Week 50
    PK/PD and Safety - over time
    Semana 12, semana 26, semana 50
    FC/FD y seguridad- a lo largo del tiempo
    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 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 trial6
    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 EEA18
    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
    Argentina
    Australia
    Brazil
    China
    Israel
    Korea, Republic of
    Mexico
    Peru
    Taiwan
    Thailand
    United States
    Spain
    Germany
    Italy
    Russian Federation
    Serbia
    Turkey
    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
    The end of study is defined as the date the last participant completes the last visit, including the OLE Period and Safety Follow-up Visit.
    El final del estudio se define como la fecha en que el último participante completa la última visita, incluyendo el periodo abierto y la Visita de Seguimiento de Seguridad
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 113
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 21
    F.4.2.2In the whole clinical trial 126
    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)
    None.
    Ninguno
    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 Decision2022-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-29
    P. End of Trial
    P.End of Trial StatusOngoing
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