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    Summary
    EudraCT Number:2020-005528-12
    Sponsor's Protocol Code Number:VIB7734.P2.S1
    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:2021-08-18
    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 number2020-005528-12
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus
    Estudio de fase II, aleatorizado, doble ciego y controlado con placebo de la eficacia y la seguridad de VIB7734 para el tratamiento del lupus eritematoso sistémico activo de moderado a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus
    Estudio de fase II, aleatorizado, doble ciego y controlado con placebo de la eficacia y la seguridad de VIB7734 para el tratamiento del lupus eritematoso sistémico activo de moderado a grave
    A.3.2Name or abbreviated title of the trial where available
    RECAST SLE
    RECAST SLE
    A.4.1Sponsor's protocol code numberVIB7734.P2.S1
    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 SponsorViela Bio, 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 supportViela Bio, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointSarah Recchio
    B.5.3 Address:
    B.5.3.1Street Address7551 Metro Center Drive
    B.5.3.2Town/ cityAustin, TX
    B.5.3.3Post code78744
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    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 nameVIB7734
    D.3.2Product code VIB7734
    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 INNVIB7734
    D.3.9.1CAS number 2245966-28-1
    D.3.9.2Current sponsor codeVIB7734
    D.3.9.3Other descriptive nameVIB7734, MEDI7734
    D.3.9.4EV Substance CodeSUB195573
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Systemic Lupus Erythematosus (SLE)
    Lupus Eritematoso Sistémico (LES)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus
    Lupus Eritematoso Sistémico
    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 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 the effect of VIB7734 compared to placebo in reducing SLE disease activity at Week 48 in participants treated with SoC therapy.
    Evaluar el efecto de VIB7734 en comparación con placebo en la reducción de la actividad del LES en la semana 48 en participantes tratados con el tratamiento de referencia.
    E.2.2Secondary objectives of the trial
    -To evaluate the effect of VIB7734 compared with placebo to reduce cutaneous disease activity at Week 12.
    -To evaluate the effect of VIB7734 compared with placebo to reduce SLE disease activity at Week 48.
    -To explore potential associations of genetic variations, gene expression, and profiles of circulating proteins with VIB7734 response.
    -To evaluate the effect of VIB7734 compared with placebo on participant-reported health-related quality of life and health assessment at Week 48.
    -To evaluate the effect of VIB7734 compared with placebo on organ damage at Week 48.
    - To characterize the PK, PD, and immunogenicity of VIB7734.
    - To evaluate the safety and tolerability of VIB7734.
    - Evaluar el efecto de VIB7734 en comparación con placebo para reducir la actividad de la enfermedad cutánea en la semana 12.
    - Evaluar el efecto de VIB7734 en comparación con placebo sobre la reducción de la actividad del LES en la semana 48.
    - Investigar posibles asociaciones entre variaciones genéticas, expresión génica y perfiles de proteínas circulantes y la respuesta a VIB7734.
    - Evaluar el efecto de VIB7734 en comparación con placebo sobre la calidad de vida relacionada con la salud y la evaluación de la salud comunicadas por los participantes en la semana 48.
    - Evaluar el efecto de VIB7734 en comparación con placebo sobre la lesión de órganos en la semana 48.
    - Caracterizar la farmacocinética, la farmacodinámica y la inmunogenicidad de VIB7734
    - Evaluar la seguridad y la tolerabilidad de VIB7734.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years to ≤ 70 years at the time of signing the ICF.
    2. Willing and able to understand and provide written informed consent prior to any study-related procedures and to comply with all study requirements and complete study assessments.
    3. Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE.
    4. Disease duration of at least 6 months from the time of diagnosis at the time of signing ICF.
    5. Active SLE as indicated by presence of all the following:
    • SLEDAI-2K total score ≥ 6 at Screening, excluding fever, SLE headache, or organic brain syndrome.
    • SLEDAI-2K total score ≥ 4, excluding points attributable to any urine or laboratory results, immunologic measures, fever, SLE headache, or organic brain syndrome at Screening and Baseline.
    • At least one of the following BILAG 2004 Index levels of disease at Screening:
    − BILAG A disease in ≥ 1 organ system
    − BILAG B disease in ≥ 2 organ systems
    • PGA score ≥ 1 on a 0 to 3 VAS at Screening.
    6. Have at least one of the following at Screening per central lab:
    • ANA ≥ 1:80.
    • Anti-dsDNA antibodies elevated to above normal range as established by the central.
    • Anti-Smith antibodies elevated to above normal.
    7. Ongoing treatment for SLE defined as (a) or (b):
    a. Treatment with one or more disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive medication: Any of the following medications each administered at conventional anti-rheumatic doses for treatment of SLE for at least 12 weeks before Screening (unless discontinued or dose adjusted for documented drug-related toxicity or size/weight), and at a stable dose (including route of administration) for a minimum of 8 weeks prior to Screening and maintained through Baseline (Day 1):
    i. Antimalarial
    ii. Azathioprine (AZA) or 6-mercaptopurine (6-MP)
    iii. Leflunomide
    iv. Mycophenolate mofetil (MMF) or mycophenolic acid (MPA)
    v. Methotrexate (MTX) (participants must be on concomitant folic or folinic acid supplementation if using MTX)
    vi. Voclosporin (if approved for treatment)
    vii. GCs are permitted but not required if a participant is receiving at least one other medication listed above. If GCs are used in combination with allowed DMARDs or immunosuppressants, they must be at an average daily dose of PO prednisone ≤ 40 mg (or prednisone equivalent) for a minimum of 2 weeks prior to Screening and at a stable dose for a minimum of 2 weeks prior to Screening. In addition, the dose of OGC must be kept stable for a minimum of 2 weeks prior to Randomization. Daily dosing or alternate day dosing of PO prednisone (or prednisone equivalent) is allowed.
    b. Treatment with OGC monotherapy (without the concomitant use of DMARDs or immunosuppressants):
    i. Average daily dose of PO prednisone ≥ 10 mg but ≤ 40 mg (or prednisone equivalent) for a minimum of 4 weeks prior to Screening and at a stable dose for a minimum of 2 weeks prior to Screening. In addition, the dose of OGC must be kept stable for a minimum of 2 weeks prior to Randomization. Daily dosing or alternate day dosing of PO prednisone (or prednisone equivalent) is allowed.
    8. Women of childbearing potential must have a negative urine pregnancy test at Randomization. Women of childbearing potential are defined as those who are not surgically sterile or those who are not postmenopausal.
    Women of childbearing potential who are sexually active with a non-sterilized male partner must agree to use a highly effective method of contraception from signing of the informed consent, and must agree to continue using such precautions through the end of the study follow-up or 3 months (approximately 5 half-lives) following the last dose of IP in the case of early withdrawal from the study. A decision about contraception after this point should be made by the participant and her regular healthcare providers.
    Sustained abstinence is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
    Note that because mycophenolate affects the metabolism of hormonal contraceptives and may reduce their effectiveness in women receiving MMF or MPA who are using hormonal contraceptives for birth control, the participant must employ an additional contraceptive method.
    9. Non-sterilized male participants who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Randomization and until 3 months (approximately 5 half-lives) after receipt of the last dose. Because a male condom with spermicide is not a highly effective contraception method, it is strongly recommended that male participants advise their women partners of childbearing potential to use a highly effective method of contraception throughout this period.
    1. Edad ≥18 años a ≤70 años en el momento de firmar el DCI.
    2. Disposición y capacidad para entender y otorgar el consentimiento informado por escrito antes de realizar ningún procedimiento relacionado con el estudio, así como para cumplir todos los requisitos y completar las evaluaciones del estudio.
    3. Cumplir los criterios de clasificación del LES de la Liga Europea contra el Reumatismo/American College of Rheumatology de 2019.
    4. Duración de la enfermedad de al menos 6 meses desde el diagnóstico en el momento de la firma del DCI.
    5. LES activo, indicado por la presencia de todo lo siguiente:
    • Puntuación total SLEDAI-2K ≥6 en la selección, excluida la fiebre, la cefalea del LES o el síndrome cerebral orgánico.
    • Puntuación total SLEDAI-2K ≥4, excluidos los puntos atribuibles a resultados de orina o de laboratorio, medidas inmunológicas, fiebre, cefalea del LES o síndrome cerebral orgánico en la selección y el momento basal (día 1).
    • Al menos uno de los siguientes niveles de enfermedad del índice BILAG 2004 en la selección:
    − BILAG A en ≥1 sistema de órganos.
    − BILAG B en ≥2 sistemas de órganos.
    • Puntuación PGA ≥1 en una escala analógica visual (EAV) de 0 a 3 en la selección.
    6. Presentar al menos una de las circunstancias siguientes en la selección:
    • ANA ≥1:80.
    • Elevación de los anticuerpos anti-ADNbc por encima del intervalo normal según lo determinado por el laboratorio central.
    • Elevación de los anticuerpos anti-Smith por encima del valor normal.
    7. Tratamiento en curso del LES, definido como (a) o (b):
    a. Tratamiento con uno o más fármacos antirreumáticos modificadores de la enfermedad (FARME) o medicación inmunodepresora: cualquiera de los siguientes medicamentos, cada uno administrado a dosis antirreumáticas convencionales para el tratamiento del LES durante al menos 12 semanas antes de la selección y a una dosis estable durante al menos 8 semanas antes de la selección y mantenida hasta el momento basal (día 1):
    i. Antipalúdicos
    ii. Azatioprina (AZA) o 6-mercaptopurina (6-MP)
    iii. Leflunomida
    iv. Micofenolato mofetilo (MMF) o ácido micofenólico (MPA)
    v. Metotrexato (MTX)
    vi. Voclosporina
    vii. Se permiten los GC, pero no son necesarios si un participante está recibiendo al menos otro medicamento mencionado anteriormente. Si se utilizan GC en combinación con FARME o inmunodepresores permitidos, deberán haber recibido una dosis diaria media de prednisona oral ≤40 mg (o equivalente de prednisona) durante un mínimo de 2 sem antes de la selección y una dosis estable durante un mínimo de 2 sem antes de la selección. Además, la dosis de GCO deberá mantenerse estable durante un mínimo de 2 sem antes de la aleatorización. Se permite la administración diaria o en días alternos de prednisona oral (o equivalente de prednisona).
    b. Tratamiento con GCO en monoterapia:
    i. Dosis diaria media de prednisona oral ≥10 mg pero ≤40 mg (o equivalente de prednisona) durante un mínimo de 4 sem antes de la selección y en una dosis estable durante un mínimo de 2 sem antes de la selección. Además, la dosis de GCO deberá mantenerse estable durante un mínimo de 2 sem antes de la aleatorización. Se permite la administración diaria o en días alternos de prednisona oral (o equivalente de prednisona).
    8. Las mujeres en edad fértil deben tener una prueba de embarazo negativa en orina en la aleatorización Las mujeres en edad fértil se definen como las que no están esterilizadas quirúrgicamente o las que no son posmenopáusicas.
    Las mujeres en edad fértil que mantengan relaciones sexuales con una pareja masculina no esterilizada deberán comprometerse a utilizar un método anticonceptivo muy eficaz desde la firma del CI y a seguir adoptando tales precauciones hasta el final del seguimiento del estudio o hasta 3 meses después de la última dosis del PEI en caso de retirada prematura del estudio. La participante y su médico habitual deberán tomar una decisión sobre el uso de anticonceptivos después de ese momento.
    La abstinencia mantenida es una práctica aceptable; sin embargo, la abstinencia periódica, el método del ritmo y el método de retirada no son métodos anticonceptivos aceptables.
    Hay que señalar que, dado que el micofenolato afecta al metabolismo de los anticonceptivos hormonales y puede reducir su eficacia en las mujeres tratadas con MMF o AMF que utilicen anticonceptivos hormonales, la participante deberá utilizar un método anticonceptivo adicional
    9. Los participantes varones no esterilizados que mantengan relaciones sexuales con una pareja femenina en edad fértil deberán comprometerse a utilizar preservativo con espermicida desde la aleatorización hasta 3 meses después de recibir la última dosis. Dado que el preservativo masculino con espermicida no es un método anticonceptivo muy eficaz, se recomienda que los varones participantes indiquen a sus parejas mujeres en edad fértil que utilicen un método anticonceptivo muy eficaz durante todo este período.
    Ver protocolo para más detalles
    E.4Principal exclusion criteria
    1. Individuals involved in the conduct of the study, their employees, or immediate family members of such individuals.
    2. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of participant safety or study results.
    3. History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous mAb or human Ig therapy.
    4. Participation in another clinical study with an investigational drug within 4 weeks prior to Day 1 or within 5 published half-lives, whichever is longer.
    5. Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP.
    6. History of drug or alcohol abuse that, in the opinion of the Investigator, might affect participant safety or compliance with visits, or interfere with other study assessments.
    7. Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through Day 393.
    8. Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to Screening.
    9. Known history of a primary immunodeficiency or an underlying condition such as known HIV infection, a positive result for HIV infection per central laboratory, splenectomy, or any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection.
    10. At Screening, any of the following per central laboratory:
    • Aspartate aminotransferase (AST) > 2.5× upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) > 2.5× ULN
    • Total bilirubin > 1.5× ULN (unless due to Gilbert’s syndrome)
    • Serum IgG < 600 mg/dL (or < 6 g/L)
    • Neutrophil count < 1000/μL (or < 1.0×109/L) or < 500/μL (< 0.5×109/L) if due to active SLE
    • Platelet count < 50,000/μL (or < 50×109/L) or < 25,000/μL (< 25×109/L) if due to active SLE
    • Hemoglobin < 8 g/dL (or < 80 g/L) or < 7 g/dL (< 70 g/L) if due to active SLE
    • Glycosylated hemoglobin > 8% (or > 0.08)
    • Total lymphocyte count < 200 cells/mm3
    • Glomerular filtration rate < 30 mL/min/1.73 m2
    • Spot UPCr > 3 mg/mg
    11. Confirmed positive test for hepatitis B serology defined as:
    • Hepatitis B surface antigen, or
    • Hepatitis B core antibody AND hepatitis B virus DNA detected above the lower limit of quantitation by reflex testing by the central laboratory at Screening.
    12. Positive test for hepatitis C virus antibody.
    13. Active TB, or a positive IFN-gamma release assay test at Screening, unless documented history of appropriate treatment for active or latent TB.
    14. Any severe herpes virus family infection at any time prior to Randomization, including, but not limited to, disseminated herpes, herpes encephalitis, recent recurrent herpes zoster, or ophthalmic herpes.
    15. Any herpes zoster, CMV, or Epstein-Barr virus infection that was not completely resolved 12 weeks prior to Randomization.
    16. Any of the following within 30 days prior to signing the ICF and though Randomization:
    • Clinically significant active infection in the opinion of the Investigator, including ongoing, and chronic infection requiring antibiotics or antiviral medication.
    • Any infection requiring hospitalization or treatment with IV anti-infectives.
    • A participant with a documented positive SARS-CoV-2 test may be rescreened at least 2 weeks after a positive test if the participant is asymptomatic and at least 3 weeks after symptomatic COVID-19 illness.
    17. Opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within 2 years prior to Randomization.
    18. Any acute illness or evidence of clinically significant active infection, such as fever ≥ 38.0°C (≥ 100.5°F) on Day 1.
    19. History of clinically significant cardiac disease including unstable angina; myocardial infarction within 6 months prior to Randomization; congestive heart failure; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities; or presence of clinically significant abnormality on ECG if, in the opinion of the Investigator, it would increase the risk of study participation.
    20. History of cancer within the past 5 years, except as follows:
    • In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to Screening, or
    • Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapy.
    21. Receipt of a live-attenuated vaccine within 4 weeks prior to Day 1. Administration of inactivated (killed) vaccines is acceptable.
    22. Participant should be assessed for epidemiologic risk of COVID-19 and for health-related risk of COVID-19 severity based on current understanding of risk factors for severe disease when making a decision regarding the individual’s risk of participation
    1. Personas implicadas en la realización del estudio, sus empleados o sus familiares inmediatos.
    2. Cualquier trastorno que, en opinión del investigador, pueda interferir en la evaluación del PEI, en la interpretación de la seguridad de los participantes o en los resultados del estudio.
    3. Antecedentes de alergia, reacción de hipersensibilidad o anafilaxia a cualquier componente del PEI o a un tratamiento previo con AcM o Ig humana.
    4. Participación en otro estudio clínico con un fármaco en investigación en las 4 semanas previas al día 1 o en el período equivalente a 5 semividas publicadas, lo que suponga más tiempo.
    5. Mujeres embarazadas o en la lactancia o mujeres que tengan intención de quedarse embarazadas en cualquier momento desde la firma del DCI hasta 6 meses después de recibir la última dosis del PEI.
    6. Antecedentes de alcoholismo o toxicomanía que, en opinión del investigador.
    7. Intervención de cirugía mayor en las 8 sem previas a la selección o intervención quirúrgica programada entre la selección y el día 393.
    8. Aborto espontáneo o inducido, mortinato, recién nacido vivo o embarazo ≤4 sem antes de la selección.
    9. Antecedentes de inmunodeficiencia primaria o de un trastorno subyacente, como infección conocida por el virus de la inmunodeficiencia humana (VIH), resultado positivo para la infección por el VIH según el laboratorio central, esplenectomía o cualquier trastorno subyacente que, en opinión del investigador, predisponga claramente al participante a contraer infecciones.
    10. En la selección, cualquiera de las circunstancias siguientes según el laboratorio central:
    • AST >2,5 veces el límite superior de la normalidad (LSN).
    • ALT >2,5 veces el LSN
    • Bilirrubina total >1,5 veces el LSN.
    • IgG sérica <600 mg/dl (o <6 g/l)
    • Recuento de neutrófilos <1000/μl (o <1,0×109/l) o <500/μl (<0,5×109/l) si se debe al LES activo
    • Recuento de plaquetas <50.000/µl (o <50×109/l) o <25.000/µl (<25×109/l) si se debe al LES activo
    • Hemoglobina <8 g/dl (o <80 g/l) o <7 g/dl (<70 g/l) si se debe al LES activo
    • Hemoglobina glucosilada >8 % (o >0,08)
    • Recuento total de linfocitos <200 células/mm3
    • Filtración glomerular <30 ml/min/1,73 m2
    • CPCO en muestra de orina >3 mg/mg
    11. Serología positiva confirmada de la hepatitis B, definida como:
    • Antígeno de superficie de Hepatitis B (HBsAg); o bien
    • Detección de anticuerpos contra el antígeno central del virus de la hepatitis B (anti-HBc) Y ADN del virus de la hepatitis B (VHB) por encima del límite inferior de cuantificación (LIC) mediante pruebas reflejas en el laboratorio central en la selección.
    12. Prueba positiva de anticuerpos contra el virus de la hepatitis C.
    13. TB activa o resultado positivo en el análisis de liberación de IFN-gamma (IGRA) en la selección, a menos que se hayan documentado antecedentes de tratamiento adecuado para TB activa o latente.
    14. Cualquier infección grave de la familia del virus del herpes en cualquier momento antes de la aleatorización, entre otras, herpes diseminado, encefalitis herpética, herpes zóster recurrente reciente o herpes oftálmico.
    15. Cualquier infección por herpes zóster, CMV o virus de Epstein-Barr que no se haya resuelto por completo 12 semanas antes de la aleatorización.
    16. Cualquiera de los procesos siguientes en los 30d previos a la firma del DCI y durante la aleatorización:
    • Infección activa de importancia clínica en opinión del investigador, incluida infección en curso y crónica con necesidad de antibióticos o antivirales.
    • Toda infección que requiera hospitalización o tratamiento con antiinfecciosos IV.
    • Un participante con una prueba positiva documentada de SARS-CoV-2 podrá someterse de nuevo al proceso de selección al menos 2 sem después de una prueba positiva si está asintomático y al menos 3 sem después de una enfermedad COVID-19 sintomática.
    17. Infección oportunista con necesidad de hospitalización o tratamiento antimicrobiano parenteral en los 2 años previos a la aleatorización.
    18. Cualquier enfermedad aguda o signos de infección activa de importancia clínica, como fiebre ≥38,0 °C el día 1.
    19. Antecedentes de cardiopatía de importancia clínica, como angina inestable; infarto de miocardio en los 6 meses previos a la aleatorización; insuficiencia cardíaca congestiva; arritmia que requiera tratamiento activo, excepto extrasístoles clínicamente insignificantes o anomalías menores de la conducción; o presencia de una anomalía de importancia clínica en el ECG si, en opinión del investigador, aumentaría el riesgo de participar en el estudio.
    20. Antecedentes de cáncer en los últimos 5 años, excepto:
    • Carcinoma in situ de cuello uterino
    • Carcinoma basocelular o espinocelular cutáneo.
    21. Vacunación con una vacuna de virus vivos atenuados en las 4 sem previas al día 1. Es aceptable la administración de vacunas inactivadas.
    22. Ha de evaluarse al participante para determinar el riesgo epidemiológico de COVID-19.
    Ver protocolo para más detalles.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of participants achieving a BILAG 2004 Indexbased Combined Lupus Assessment (BICLA) response and an oral (PO) prednisone (or equivalent) dose of ≤ 7.5 mg/day and ≤ Baseline (Day 1) dose
    Proporción de participantes que logren una respuesta en la Evaluación Combinada del Lupus basada en el Índice BILAG 2004 (BICLA) y una dosis de glucocorticoides orales (GCO) ≤7,5 mg/día y ≤dosis basal (día 1) de prednisona o equivalente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Semana 48
    E.5.2Secondary end point(s)
    • Proportion of participants with CLASI-A score ≥ 10 at Baseline (Day 1) who achieve ≥ 50% reduction from baseline (Day 1) in CLASI-A score.
    • Proportion of participants achieving an SRI-4 response and an OGC dose ≤ 7.5 mg/day and ≤ Baseline (Day 1) dose of prednisone or equivalent
    • Proportion of participants at OGC dose ≥ 10 mg prednisone or equivalent at Baseline (Day 1) who:
    - Achieve OGC dose ≤ 7.5 mg/day prednisone or equivalent at Week 36.
    - Maintain OGC dose ≤ 7.5 mg/day from Week 36 through Week 48.
    - No use of restricted medications beyond the protocol-allowed threshold before assessment.
    - No discontinuation of IP.
    • Proportion of participants achieving LLDAS.
    • VIB7734 concentrations, change in pDCs, and ADA rate.
    • Incidence of AEs, SAEs, and AESIs
    • Proporción de participantes con una puntuación ≥10 en el Índice de superficie y gravedad de la enfermedad en el lupus eritematoso cutáneo (CLASI)-Actividad (CLASI-A) en el momento basal (día 1) que logren una reducción ≥50 % de la puntuación CLASI-A entre el momento basal (día 1).
    • Proporción de participantes que logren una respuesta en el Índice de respuesta del lupus sistémico (SRI)-4 y una dosis de GCO ≤7,5 mg/día y ≤dosis basal (día 1) de prednisona o equivalente .
    • Proporción de participantes tratados con una dosis de GCO ≥10 mg de prednisona o equivalente en el momento basal (día 1) que:
    -logren una dosis de GCO ≤7,5 mg/día de prednisona o equivalente en la semana 36
    - mantengan una dosis de GCO ≤7,5 mg/día de prednisona o equivalente en la semana 36 y hasta la semana 48.
    -No hay uso de medicamentos restringidos más allá del umbral permitido por el protocolo antes de la evaluación.
    - No discontinuación del PI.
    • Proporción de participantes que logren un estado de actividad baja del lupus
    • Concentraciones de VIB7734, cambio en las CDp y tasa de anticuerpos contra el fármaco.
    • Incidencia de acontecimientos adversos (AA), AA graves y AA de interés especial.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12, Week 36, and Week 48
    AE, SAE AESIs check required per protocol
    Semana 12, semana 36 y semana 48.
    Revisar Acontecimientos adversos (AA), AA graves y AA de interés especial requeridos por 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 Yes
    E.6.11Pharmacogenomic Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    India
    Mexico
    Russian Federation
    Serbia
    Taiwan
    Ukraine
    United States
    Poland
    Spain
    Argentina
    Greece
    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 date of the last protocol-specified visit/assessment for the last participant in the study
    La fecha de la última visita/evaluación especificada por el protocolo para el último participante en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned 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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-08-18. Yes
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 94
    F.4.2.2In the whole clinical trial 195
    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)
    A long-term extension (LTE) study for safety and efficacy may be offered as part of a separate protocol, to participants who complete the Week 48 visit
    Se puede ofrecer un estudio de extensión a largo plazo (LTE) para la seguridad y eficacia como parte de un protocolo separado, a los participantes que completen la visita de la Semana 48
    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 Decision2021-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-19
    P. End of Trial
    P.End of Trial StatusOngoing
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