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    Summary
    EudraCT Number:2020-000727-40
    Sponsor's Protocol Code Number:230LE301
    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:2022-06-09
    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 number2020-000727-40
    A.3Full title of the trial
    A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus with or without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
    Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de 2 partes sin interrupciones, parte A (fase II)/parte B (fase III), para evaluar la eficacia y la seguridad de BIIB059 en participantes con lupus eritematoso cutáneo subagudo activo o lupus eritematoso cutáneo crónico con o sin manifestaciones sistémicas y resistente o intolerante al tratamiento antipalúdico (AMETHYST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy
    Estudio para evaluar la eficacia y la seguridad de BIIB059 en participantes con lupus eritematoso cutáneo subagudo activo o lupus eritematoso cutáneo crónico con o sin manifestaciones sistémicas y resistente o intolerante al tratamiento antipalúdico
    A.3.2Name or abbreviated title of the trial where available
    AMETHYST
    AMETHYST
    A.4.1Sponsor's protocol code number230LE301
    A.5.4Other Identifiers
    Name:INDNumber:135703
    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 SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointBiogen España
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 41
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913107110
    B.5.5Fax number+34913107181
    B.5.6E-mailclinicaltrials@biogen.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 nameNot applicable
    D.3.2Product code BIIB059
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codeBIIB059
    D.3.9.3Other descriptive nameHumanised IgG1 monoclonal antibody against blood dendritic cell antigen 2
    D.3.9.4EV Substance CodeSUB208560
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 typerecombinant monoclonal 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 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
    Subacute Cutaneous Lupus Erythematosus
    Chronic Cutaneous Lupus Erythematosus
    Lupus eritematoso cutáneo subagudo
    Lupus eritematoso cutáneo crónico
    E.1.1.1Medical condition in easily understood language
    Lupus
    Lupus
    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 10056509
    E.1.2Term Cutaneous lupus erythematosus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057903
    E.1.2Term Subacute cutaneous lupus erythematosus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057929
    E.1.2Term Chronic cutaneous lupus erythematosus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    Part A(Phase 2): to evaluate the efficacy of BIIB059 compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician’s Global Assessment-Revised(CLA-IGA-R) in participants with active subacute cutaneous lupus erythematosus(SCLE) and/or chronic cutaneous lupus erythematosus(CCLE) with or without systemic manifestations and refractory and/or intolerant to antimalarials.
    Part B (Phase 3)- United States: to demonstrate the efficacy of BIIB059 compared with placebo in reducing skin disease activity measured by the CLA-IGA-R in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials.
    Part B (Phase 3)- Rest of World: to demonstrate the efficacy of BIIB059 compared with placebo in reducing skin disease activity measured by CLASI-A score in participant with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials.
    Parte A (fase II): evaluar eficacia de BIIB059 vs placebo en la reducción de la actividad de enfermedad cutánea medida por la actividad lúpica cutánea en la Evaluación global revisada por el médico (CLA-IGA-R) en participantes con lupus eritematoso cutáneo subagudo (LECSA) activo o lupus eritematoso cutáneo crónico (LECC) con o sin manifestaciones sistémicas y resistente o intolerante a los antipalúdicos.
    Parte B (fase III)-EEUU: demostrar eficacia de BIIB059 vs placebo en la reducción de la actividad de enfermedad cutánea medida por CLA-IGA-R en participantes con LECSA activo o LECC con o sin manifestaciones sistémicas y resistente o intolerante a los antipalúdicos.
    Parte B (fase III) -Resto del mundo: demostrar la eficacia de BIIB059 en comparación con placebo en la reducción de la actividad de la enfermedad cutánea medida por la puntuación CLASI-A en participantes con LECSA activo o LECC con o sin manifestaciones sistémicas y resistente o intolerante a los antipalúdicos
    E.2.2Secondary objectives of the trial
    Part A: to evaluate the efficacy of BIIB059 compared with placebo in reducing skin disease activity as measured by the CLA-IGA-R, CLASI-A score, CLA-IGA-R erythema characteristic or 4 morphological characteristics jointly; to evaluate additional efficacy of BIIB059 compared with placebo in reducing skin disease activity, to evaluate sustained efficacy of BIIB059 who received BIIB059 treatment during both the 24-week DBPC and the 28-week ETP.
    Part B (US and ROW): to evaluate additional efficacy of BIIB059 compared with placebo in reducing skin disease activity, to evaluate the sustained effect of BIIB059 who received BIIB059 treatment during both the 24-week DBPC treatment period and the 28-week ETP, to evaluate the efficacy of BIIB059 who switched from placebo to BIIB059 during the ETP, to evaluate the effect of BIIB059 compared to placebo in preventing disease worsening.
    Note: Please refer to study protocol for full list of secondary objectives of the trial.
    ParteA: evaluar eficacia de BIIB059vsplacebo en la reducción de actividad de enfer cutánea medida por CLA-IGA-R, puntuación CLASI-A, característica del eritema según CLA-IGA-R o 4 características morfológicas conjuntas; evaluar eficacia adicional de BIIB059vsplacebo en reducción de actividad de la enfer cutánea, evaluar eficacia constante de BIIB059 en participantes que recibieron el tto con BIIB059 durante el doble ciego controlado con placebo (DCCP) de 24 semanas y ETP de 28 semanas.
    Parte B(EEUU y resto del mundo):evaluar eficacia adicional de BIIB059vsplacebo en reducción de actividad de enfer cutánea, evaluar efecto constante de BIIB059 en participantes que recibieron tto con BIIB059 durante periodo de tto DCCP de 24 semanas y ETP de 28 semanas, evaluar eficacia de BIIB059 en participantes que cambiaron de placebo a BIIB059 durante ETP, evaluar efecto de BIIB059vsplacebo en prevención del empeoramiento de la enfer. Nota:ver protocolo para todos los objetivos secundarios.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    1. Histologically confirmed (in the past or at Screening) diagnosis of CLE with or without systemic manifestations.
    2. Must have active cutaneous manifestations that meet the following criteria:
    a. at least 1 active SCLE lesion with a minimum CLASI-A erythema score ≥ 2 and CLASI-A scaling score ≥1; AND/OR
    b. at least 1 active CCLE lesion with a minimum CLASI-A erythema score ≥ 2 and CLASI-D score of scarring ≥ 1
    c. a CLA-IGA-R erythema score ≥3 and a score ≥1 in the 4 morphological characteristics jointly of the CLA-IGA-R (scale, edema, follicular involvement, or secondary change)
    3. Must have a CLASI-A score ≥ 10 adjudicated at Screening and confirmed by the Investigator at randomization.
    4. Must have a CLA-IGA-R score ≥3 adjudicated at Screening and confirmed by the Investigator at randomization.
    5. Must have an active CLE lesion despite an adequate trial of antimalarial treatment. One of the 2 conditions should be met:
    a. antimalarial agents used for at least 12 weeks (not continuous is acceptable) prior to Screening OR
    b. previously documented discontinuation of antimalarial agents due to poor tolerability and/or side effects, and/or lack of therapeutic effect for at least 12 weeks of treatment (and not continuous is acceptable).
    Criterios de inclusión principales:
    1.Diagnóstico de LEC confirmado histológicamente (en el pasado o en la selección) con manifestaciones sistémicas o sin ellas.
    2.Deben tener manifestaciones cutáneas activas que cumplan lo siguiente:
    a.al menos 1 lesión activa de LECSA con una puntuación mínima de eritema en CLASI-A ≥2 y una puntuación de descamación en CLASI-A ≥1; O
    b.al menos 1 lesión activa de LECC con una puntuación mínima de eritema en CLASI-A ≥2 y una puntuación de cicatrización en CLASI-A ≥1
    c.una puntuación de eritema según CLA-IGA-R ≥3 y una puntuación ≥1 en las 4 características morfológicas conjuntas de CLA-IGA-R (descamación, edema, afectación folicular o cambio secundario)
    3.Deben tener una puntuación CLASI-A ≥10 adjudicada en la selección y confirmada por el investigador en la aleatorización.
    4.Deben tener una puntuación CLA-IGA-R ≥3 adjudicada en la selección y confirmada por el investigador en la aleatorización.
    5.Debe tener una lesión activa de LEC a pesar de un ensayo adecuado de tratamiento antipalúdico. Se debe cumplir una de las 2 condiciones:
    a.fármacos antipalúdicos utilizados durante al menos 12 semanas (es aceptable que no sean continuas) antes de la selección O
    b.interrupción confirmada previamente de los fármacos antipalúdicos debido a mala tolerabilidad o efectos secundarios, o falta de efecto terapéutico durante al menos 12 semanas de tratamiento (y es aceptable que no sean continuas).
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE such as but not limited to psoriasis, non-LE alopecia areata, non-LE skin lupus manifestation (e.g., cutaneous vascular disease, periungual telangiectasia, sclerodactyly, rheumatoid nodules, erythema multiform, leg ulcers) or drug-induced lupus.
    2. Active severe lupus nephritis where, in the opinion of the Investigator, protocol-specified standard of care (SoC) is insufficient and use of a more aggressive therapeutic approach, such as adding intravenous (IV) cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated; or urine protein-creatinine ratio > 2.0 or severe chronic kidney disease (estimated glomerular filtration rate < 30 milliliters per minute [mL/min/1.73 m^2]) calculated using the abbreviated Modification of Diet in Renal Disease equation.
    3. Active neuropsychiatric SLE including, but not limited to, the following: seizure, new or worsening impaired level of consciousness, psychosis, delirium or confusional state, aseptic meningitis, ascending or transverse myelitis, chorea, cerebellar ataxia, mononeuritis multiplex, or demyelinating syndromes that would make the participant unable to fully understand the informed consent form (ICF); or where in the opinion of the Investigator, protocol-specified background nonbiologic lupus SoC therapy is insufficient and use of a more aggressive therapeutic approach such as adding IV cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol is indicated.
    4. Use of immunosuppressive or disease-modifying treatments for SLE or CLE (via an oral, IV, or SC route) that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose for at least 4 weeks prior to randomization, or have
    been taken during the last 12 weeks prior to randomization at doses above the prescribed maximum listed here (medication list includes, but is not limited to the following: dapsone 150 mg/day, azathioprine 200 mg/day, 6-mercaptopurine 100 mg/day, mycophenolate [either as mycophenolate mofetil (MMF) 3000 mg/day or mycophenolate sodium (MPS) 2160 mg/day] or methotrexate 25 mg/week).
    5. Any abnormal laboratory test result at Screening that is considered clinically significant and unrelated to the underlying disease (SLE or CLE), as determined by the Investigator, and would preclude the participant from participating in the study.
    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
    Criterios de exclusión principales:
    1.Cualquier afección cutánea activa distinta del LEC (lupus eritematoso crónico) que pueda interferir en las evaluaciones del estudio del LEC, como, entre otras, psoriasis, alopecia areata no relacionada con LE, manifestación cutánea de lupus no relacionada con LE (p. ej., enfermedad vascular cutánea, telangiectasia periungueal, esclerodactilia, nódulos reumatoides, eritema multiforme, úlceras en las piernas) o lupus de origen medicamentoso.
    2.Nefritis por lupus grave activa donde, en opinión del investigador, la práctica clínica habitual especificada en el protocolo es insuficiente y esté indicado el uso de un enfoque terapéutico más agresivo, como añadir ciclofosfamida intravenosa (i.v.) o tratamiento con corticoesteroides en pulso i.v. en dosis altas u otros tratamientos no permitidos en el protocolo; o cociente proteína-creatinina en orina >2,0 o enfermedad renal crónica grave (tasa de filtración glomerular estimada <30 mililitros por minuto [ml/min/1,73 m^2]) calculada mediante la ecuación abreviada de modificación de la dieta en la enfermedad renal.
    3.LES neuropsiquiátrico activo que comprende, entre otros, lo siguiente: convulsiones, alteración del nivel de consciencia nuevo o empeorado, psicosis, delirio o estado de confusión, meningitis aséptica, mielitis ascendente o transversal, corea, ataxia cerebelosa, mononeuritis múltiple, o síndromes desmielinizantes que harían que el participante no pudiera entender por completo el formulario de consentimiento informado (FCI); o cuando, en opinión del investigador, la práctica clínica habitual de base para el lupus no biológico especificado en el protocolo es insuficiente y está indicado el uso de un enfoque terapéutico más agresivo, como la adición de ciclofosfamida i.v. o tratamiento con corticoesteroides en pulso i.v. a dosis altas u otros tratamientos no permitidos en el protocolo.
    4.Uso de tratamientos inmunodepresores o modificadores de la enfermedad para LES o LEC (por vía oral, i.v. o s.c.) iniciados menos de 12 semanas antes de la aleatorización, no haber recibido una dosis estable y permitida durante al menos 4 semanas antes de la aleatorización, o que se han tomado durante las últimas 12 semanas antes de la aleatorización a dosis superiores al máximo prescrito que se indica aquí (la lista de medicamentos comprende, entre otros, los siguientes: dapsona 150 mg/día, azatioprina 200 mg/día, 6-mercaptopurina 100 mg/día, micofenolato [como micofenolato de mofetilo (MMF) 3000 mg/día o micofenolato de sodio (MPS) 2160 mg/día] o metotrexato 25 mg/semana).
    5.Cualquier resultado anómalo de las pruebas analíticas en la selección que se considere clínicamente significativo y no relacionado con la enfermedad subyacente (LES o LEC), según lo determine el investigador, y que impida al participante participar en el estudio.
    NOTA: podrán aplicarse otros criterios de inclusión/exclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    *Parts A and B (US): Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician’s Global Assessment-Revised (CLA-IGA-R) Score of 0 or 1
    *Part B (ROW): Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response
    * Partes A y B (EE. UU.): porcentaje de participantes que logran una puntuación de 0 o 1 de actividad lúpica cutánea en la Evaluación global revisada por el médico (CLA-IGA-R)
    * Parte B (Resto del Mundo RDM): porcentaje de participantes que logran una respuesta en la puntuación de actividad del índice de gravedad y superficie de la enfermedad de lupus eritematoso cutáneo (CLASI-70)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Parts A and B (US): Week 16; Part B (ROW): Week 24
    Partes A y B (EE. UU.): semana 16; parte B (RDM): semana 24
    E.5.2Secondary end point(s)
    *Parts A and B (ROW): Percentage of Participants who Achieve a CLA-IGA-R Score of 0 or 1
    *Parts A and B (US): Percentage of Participants who Achieve a CLASI-70 Response
    *Part A: Percentage of Participants who Achieve a CLASI-50 Response
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a Score of 0 or 1 in the CLA-IGA-R Erythema Characteristic
    *Parts A and B (US and ROW): Percentage of Participants who Achieve at Least 1 Level of Improvement in the 4 Morphological Characteristics Jointly
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a Score of 0 or 1 in the CLA-IGA-R Erythema Characteristic OR at Least 1 Level of Improvement in the 4 Morphological Characteristics Jointly
    *Parts A and B (US and ROW): Percentage of Participants who Achieve any Improvement in the Global Score of the CLA-IGA-R
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a CLASI-A Score 0 to 1
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a CLASI-A Score 0 to 3
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a 7-Point Reduction From Baseline CLASI-A Score
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a 50% Reduction in CLASI-A
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a 70% Reduction in CLASI-A
    *Parts A and B (US and ROW): CLA-IGA-R Erythema Sub-Total Score
    *Parts A and B (US and ROW): CLA-IGA-R Scale-Hypertrophy Sub-Total Score
    *Parts A and B (US and ROW): Percentage of Participants who Achieve a Score of 0 to 1 in CLASI-A Erythema sub-Total Score and in the Scale-Hypertrophy sub-Total Score
    *Parts A and B (US and ROW): Percentage of Participants who Achieve any Improvement in Nonscarring Alopecia and Hair Loss by a Measure of CLASI-A Subcomponents
    *Parts A and B (US and ROW): Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders who Receive BIIB059 During the DBPC Treatment Period at Weeks 16 [Part A/Part B(US)] and 24 [Part A/Part B(ROW)]
    *Parts A and B (US and ROW): Percentage of Participants With a CLA-IGA-R 0 to 1 Response Among Responders who Receive BIIB059 During the DBPC Treatment Period With a CLA-IGA-R Score of 0 to 1 at Weeks 16 [Part A/Part B(US)] and 24 [Part A/Part B(ROW)]
    *Parts A and B (US and ROW): Percentage of Participants With CLASI-70 Response Among CLASI-70 Nonresponders who Receive Placebo During the DBPC Treatment Period at Weeks 16 [Part A/Part B(US)] and 24 [Part A/Part B(ROW)]
    *Parts A and B (US and ROW): Percentage of Participants With a CLA-IGA-R 0 to1 Response Among CLA-IGA-R 0 to1 Nonresponders who Receive Placebo During the DBPC Treatment Period at Weeks 16 [Part A/Part B(US)] and 24 [Part A/Part B(ROW)]
    *Parts A and B (US and ROW): Annualized Mild and Moderate SELENA-SLEDAI Flare Index (SFI) Rate and Annualized Severe SFI Rate Through Weeks 16, 24 and 52
    *Part A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score
    Parts A and B (US and ROW): Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    *Parts A and B (US and ROW): Number of Participants With Anti-BIIB059 Antibodies in Serum During the Duration of the Study
    *Part B (US and ROW): Percentage of Participants who Achieve CLA-IGA-R 0 to 1 in the Global Score
    *Part B (US and ROW): Absolute and Percent Change in CLASI-D
    *Part B (US and ROW): Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL)
    *Part B (US and ROW): Change From Baseline in Dermatology Life Quality Index (DLQI)
    *Part B (US and ROW): Impression of Change Items From Subject Global Assessment of Skin-Follow-up (SGA-Skin-FU)
    *Part B (US and ROW): Difference Between Global Assessment Items From Subject Global Assessment of Skin-Baseline (SGA-Skin-BL) at Baseline and the Same Items in SGA-Skin-FU
    * Partes A y B (RDM): porcentaje de participantes que logran una puntuación CLA-IGA-R de 0 o 1
    * Partes A y B (EE. UU.): porcentaje de participantes que logran una respuesta CLASI-70
    *Parte A: porcentaje de participantes que logran una respuesta CLASI-50
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes que logran una puntuación de 0 o 1 en la característica de eritema según CLA-IGA-R
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes que logran al menos 1 nivel de mejora en las 4 características morfológicas conjuntamente
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes que logran una puntuación de 0 a 1 en la característica de eritema según CLA-IGA-R O BIEN al menos 1 nivel de mejora en las 4 características morfológicas conjuntamente
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes que logran cualquier mejora en la puntuación global de CLA-IGA-R
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes que logran una puntuación de 0 a 1 en CLASI-A
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes que logran una puntuación de 0 a 3 en la puntuación CLASI-A
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes que logran una reducción de 7 puntos con respecto a la puntuación CLASI-A inicial.
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes que logran una reducción del 50 % en CLASI-A
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes que logran una reducción del 70 % en CLASI-A
    * Partes A y B (EE. UU. y RDM): puntuación subtotal de eritema de CLA-IGA-R
    * Partes A y B (EE. UU. y RDM): puntuación subtotal de la escala de hipertrofia de CLA-IGA-R
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes que logran una puntuación de 0 a 1 en la puntuación subtotal de eritema de CLASI-A y en la puntuación subtotal de la escala de hipertrofia
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes que logran cualquier mejora en la alopecia no cicatricial y la pérdida de cabello mediante una medición de los subcomponentes de CLASI-A
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes con una respuesta CLASI-70 entre los que respondieron CLASI-70 que recibieron BIIB059 durante el periodo de tratamiento DCCP en las semanas 16 [parte A/parte B (EE. UU.)] y 24 [parte A/parte B (RDM)]
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes con una respuesta CLA-IGA-R de 0 a 1 entre los que respondieron y que recibieron BIIB059 durante el periodo de tratamiento DCCP con una puntuación CLA-IGA-R de 0 a 1 en las semanas 16 [parte A/parte B (EE. UU.)] y 24 [parte A/parte B (RDM)]
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes con respuesta CLASI-70 entre los que no respondieron CLASI-70 y que recibieron placebo durante el periodo de tratamiento DCCP en las semanas 16 [parte A/parte B (EE. UU.)] y 24 [parte A/parte B (RDM)]
    * Partes A y B (EE. UU. y RDM): porcentaje de participantes con una respuesta CLA-IGA-R de 0 a 1 entre los que no respondieron CLA-IGA-R de 0 a 1 y que recibieron placebo durante el periodo de tratamiento DCCP en las semanas 16 [parte A/parte B (EE. UU.)] y 24 [parte A/parte B (RDM)]
    * Partes A y B (EE. UU. y RDM): tasa anualizada según el índice de brotes SELENA-SLEDAI (SELENA-SLEDAI Flare Index, SFI) leve y moderada y tasa anualizada según el SFI grave hasta la semanas 16, 24 y 52.
    Parte A: cambio desde el inicio en la puntuación de daño del índice de gravedad y superficie de la enfermedad de lupus eritematoso cutáneo (CLASI-D) partes A y B (EE. UU. y RDM): número de participantes con acontecimientos adversos surgidos durante el tratamiento (AAST) y acontecimientos adversos graves (AAG)
    * Partes A y B (EE. UU. y RDM): número de participantes con anticuerpos anti-BIIB059 en suero durante todo el estudio
    * Parte B (EE. UU. y RDM): porcentaje de participantes que logran de 0 a 1 en la puntuación global de CLA-IGA-R
    * Parte B (EE. UU. y RDM): cambio absoluto y porcentual en CLASI-D
    * Parte B (EE. UU. y RDM): cambio desde el inicio en la calidad de vida con lupus eritematoso cutáneo (CLE-QoL)
    * Parte B (EE. UU. y RDM): cambio desde el inicio en el índice de calidad de vida en dermatología (DLQI)
    * Parte B (EE. UU. y RDM): impresión de los ítems de cambio desde la evaluación global del sujeto del seguimiento de la piel (SGA-Skin-FU)
    * Parte B (EE. UU. y RDM): diferencia entre los ítems de evaluación global del sujeto de la piel al inicio (SGA-Skin-BL) al inicio y los mismos ítems del SGA-Skin-FU.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16, Week 24, Up to Week 52, Baseline up to Week 52, Up to Week 76
    Semana 16, semana 24, hasta la semana 52, inicio hasta la semana 52, hasta la semana 76
    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 Yes
    E.6.13.1Other scope of the trial description
    immunogenicity and tolerability
    inmunogenicidad y tolerabilidad
    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) Yes
    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
    Diseño de estudio de 2 partes sin interrupciones
    A 2-part seamless design study
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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
    Brazil
    Canada
    Chile
    China
    Colombia
    Japan
    Korea, Republic of
    Mexico
    Philippines
    Puerto Rico
    Saudi Arabia
    Taiwan
    United States
    France
    Poland
    Sweden
    Bulgaria
    Spain
    Switzerland
    Germany
    Italy
    Belgium
    Hungary
    Portugal
    Russian Federation
    Serbia
    Slovakia
    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 the study period (i.e., DBPC followed by ETP) is Week 52/EOS.
    El final del periodo del estudio (es decir, DCCP seguido de ETP) es la semana 52/FdE
    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 months2
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days16
    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: 464
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 474
    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)
    Participants who successfully stay in treatment up to Week 52 visit will be offered the opportunity to enroll in an open-label LTE study, which will be described in a separate protocol.
    A los participantes que permanezcan en el tratamiento con éxito hasta la visita de la semana 52 se les ofrecerá la oportunidad de inscribirse en un estudio de ELP abierto, que se describirá en un protocolo por separado.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation DrugDev
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-01
    P. End of Trial
    P.End of Trial StatusOngoing
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