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    Summary
    EudraCT Number:2018-001003-36
    Sponsor's Protocol Code Number:KPL-301-C001
    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:2018-06-28
    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 number2018-001003-36
    A.3Full title of the trial
    A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis
    Estudio en fase 2, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de KPL-301 en la arteritis de células gigantes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis
    Estudio clínico para evaluar el tratamiento de KPL-301 en comparación con placebo en la arteritis de células gigantes
    A.4.1Sponsor's protocol code numberKPL-301-C001
    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 SponsorKiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.
    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 supportKiniksa Pharmaceuticals Corp.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportKiniksa Pharmaceuticals, Ltd.
    B.4.2CountryBermuda
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.
    B.5.2Functional name of contact pointKiniksa Medical Information Group
    B.5.3 Address:
    B.5.3.1Street Address100 Hayden Ave
    B.5.3.2Town/ cityLexington, Massachusetts
    B.5.3.3Post code02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number34900 834 223
    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 nameMavrilimumab
    D.3.2Product code KPL-301
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNMAVRILIMUMAB
    D.3.9.1CAS number 1085337-57-0
    D.3.9.2Current sponsor codeKPL-301
    D.3.9.3Other descriptive namen/a
    D.3.9.4EV Substance CodeSUB189175
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Prednisone Tablets, USP
    D.2.1.1.2Name of the Marketing Authorisation holderPar Pharmaceutical
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePredniSONE Tablets, USP
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboSolution for injection in pre-filled syringe
    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
    giant cell arteritis
    arteritis de células gigantes
    E.1.1.1Medical condition in easily understood language
    an inflammatory disease of blood vessels
    una enfermedad inflamatoria de los vasos sanguíneos
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018250
    E.1.2Term Giant cell arteritis
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of KPL-301 versus placebo, coadministered with a 26 week steroid taper, for maintaining sustained remission for 26 weeks in subjects with newonset or relapsing/refractory giant cell arteritis (GCA).
    El objetivo principal del estudio es evaluar la eficacia de KPL-301 en comparación con placebo, administrado junto con una reducción gradual de los esteroides durante 26 semanas, para mantener la remisión sostenida durante 26 semanas en pacientes con arteritis de células gigantes (ACG) de nueva aparición o recidivante/resistente.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study, in subjects with new-onset and relapsing/refractory GCA, are:
    a) To evaluate the effect of KPL-301 vs placebo on cumulative corticosteroid dose.
    b) To evaluate the effect of KPL-301 vs placebo on health-related quality of life (HRQoL).
    c) To evaluate the safety and tolerability of KPL-301.
    d) To evaluate the pharmacokinetics (PK) of KPL-301.
    Los objetivos secundarios del estudio, en pacientes con ACG de nueva aparición y recidivante/resistente, son los siguientes:
    a) Evaluar el efecto de KPL-301 en comparación con placebo en la dosis acumulada de corticosteroides.
    b) Evaluar el efecto de KPL-301 en comparación con placebo en la calidad de vida relacionada con la salud (CVRS).
    c) Evaluar la seguridad y la tolerabilidad de KPL-301.
    d) Evaluar la farmacocinética (FC) de KPL-301.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to provide written informed consent and to comply with the study protocol
    2. Age of ≥ 50 to 85 inclusive
    3. Diagnosis of new-onset or relapsing GCA classified according to the following criteria:
    New-onset: Initial diagnosis of GCA within 6 weeks of Day 0
    a) Westergren ESR > 30 mm/hour or CRP ≥ 1 mg/dL
    b) AND at least one of the following:
    i. Unequivocal cranial symptoms of GCA (new-onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication)
    ii. Unequivocal extracranial symptoms of GCA such as claudication of the extremities
    iii. Symptoms of PMR, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness
    c) AND at least one of the following:
    i. TAB or ultrasound revealing features of GCA
    ii. Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as MRI, CT/CTA, or PET-CT of the aorta or other great vessels
    Relapsing: Diagnosis of GCA > 6 weeks before Day 0 AND at least one of the following:
    d) Active GCA within 6 weeks of Day 0 defined as clinical sign/symptom(s) and Westergren ESR> 30 mm/hour or CRP ≥ 1 mg/ dL OR
    e) No remission since the diagnosis of disease as per clinical expectations (refractory nonremitting)
    4. Remission of GCA at Day 0 (resolution of GCA symptom(s) and CRP < 1.0 or ESR < 20 mm in the first hour), such that the subject can safely participate in the study and follow the protocol defined rocedures, including initiation of the prednisone taper at the protocol-specified starting dose (i.e., ≤60 mg/day)
    5. At Day 0, receiving or able to receive oral prednisone up to 60 mg/day for the treatment of GCA
    6. If using methotrexate (MTX), oral or parenteral up to 25mg/week is permitted in screening if started more than 6 weeks prior to Day 0 and should be stable or decreasing with the intention to discontinue use by Day 0.
    7. Willing to receive antiplatelet therapy depending on the Investigator’s decision
    8. Willing to receive treatment for prevention of corticosteroid-induced osteopenia/osteoporosis depending on the Investigator’s decision
    9. Female subjects must be:
    a) postmenopausal, defined as at least 12 months post cessation of menses (without an alternative medical cause), or
    b) permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral ophorectomy, or tubal ligation or having a male partner with vasectomy as affirmed by the subject, or
    c) nonpregnant, nonlactating, and having agreed to use an effective method of contraception (i.e., hormonal contraceptives, intrauterine device (IUD), or double barrier methods such as condom plus diaphragm or diaphragm plus spermicide or condom plus spermicide) from Screening visit until 12 weeks after final study drug administration
    10. Male subjects must have documented vasectomy or must agree to use double barrier methods of contraception (such as condom plus diaphragm or diaphragm plus spermicide or condom plus spermicide) or use condom plus hormonal contraceptives or condom plus IUD with their partners of childbearing potential from Day 0 until the Safety Follow-up visit. Male subjects must agree to refrain from donating sperm from Day 0 until the Safety Follow-up visit.
    1. Disposición y capacidad para otorgar el consentimiento informado por escrito y cumplir los requisitos del protocolo del estudio.
    2. Edad de ≥ 50 a 85 años inclusive
    3. Diagnóstico de ACG de nueva aparición o recidivante según los criterios siguientes:
    De nueva aparición: Diagnóstico inicial de ACG en las 6 semanas previas al día 0
    a) VSG de Westergren > 30 mm/hora o CRP ≥ 1 mg/dl
    b) Y al menos uno de los criterios siguientes:
    i. Síntomas craneales inequívocos de ACG (cefalea localizada de nueva aparición, sensibilidad dolorosa del cuero cabelludo o la arteria temporal, pérdida de visión por isquemia o dolor inexplicado de la boca o la mandíbula al masticar)
    ii. Síntomas extracraneales inequívocos de ACG, como claudicación de las extremidades
    iii. Síntomas de PMR, definida como dolor de hombros o cadera acompañado de rigidez matutina inflamatoria
    c) Y al menos uno de los criterios siguientes:
    i. BAT o ecografía que revele características de ACG
    ii. Signos de vasculitis de grandes vasos mediante angiografía o estudio de imagen transversal como RM, TC/ATC o PET-TC de la aorta u otros vasos grandes
    Recidiva: Diagnóstico de ACG > 6 semanas antes del día 0 Y al menos una de las características siguientes:
    d) ACG activa en las 6 semanas previas al día 0, definida como signos/síntomas clínicos y VSG de Westergren > 30 mm/hora o CRP ≥ 1 mg/dl
    O
    e) Ausencia de remisión desde el diagnóstico de la enfermedad según las expectativas clínicas (resistente sin remisión)
    4. Remisión de la ACG el día 0 (resolución de los síntomas de la ACG y CRP < 1,0 o VSG < 20 mm en la primera hora), de modo que el paciente pueda participar con seguridad en el estudio y seguir los procedimientos definidos en el protocolo, incluido el inicio de la reducción gradual de prednisona en la dosis inicial especificada en el protocolo (es decir, ≤ 60 mg/día).
    5. El día 0, recepción o capacidad de recibir hasta 60 mg/día de prednisona oral para el tratamiento de la ACG
    6. Si se utiliza metotrexato (MTX), se permiten hasta 25 mg/semana por vía oral o parenteral en la selección si se inicia más de 6 semanas antes del día 0 y debe mantenerse estable o disminuir con la intención de suspender el uso el día 0.
    7. Disposición a recibir tratamiento antiagregante plaquetario en función de la decisión del investigador
    8. Disposición a recibir tratamiento para la prevención de la osteopenia/osteoporosis inducida por corticosteroides en función de la decisión del investigador
    9. Las mujeres deben cumplir los requisitos siguientes:
    a) posmenopáusicas, definidas como al menos 12 meses después de la interrupción de la menstruación (sin una causa médica alternativa), o
    b) esterilización permanente después de histerectomía, salpingectomía bilateral, ovariectomía bilateral o ligadura de trompas documentadas, o vasectomía de la pareja masculina según la confirmación del sujeto.
    c) no embarazadas, no lactantes y haber aceptado utilizar un método anticonceptivo eficaz (es decir, anticonceptivos hormonales, dispositivo intrauterino (DIU) o métodos de doble barrera como preservativo más diafragma o diafragma más espermicida o preservativo más espermicida) desde la visita de selección hasta 12 semanas después de la última administración del fármaco del estudio.
    10. Los varones deberán haberse sometido a una vasectomía documentada o deberán comprometerse a utilizar métodos anticonceptivos de doble barrera (como preservativo más diafragma o diafragma más espermicida o preservativo más espermicida) o preservativo más anticonceptivos hormonales o preservativo más un DIU con sus parejas en edad fértil desde el día 0 hasta la visita de seguimiento de la seguridad. Los varones deberán comprometerse a no donar semen desde el día 0 hasta la visita de seguimiento de la seguridad.
    E.4Principal exclusion criteria
    General Exclusion Criteria
    1. Major surgery within 8 weeks prior to Screening or planned major surgery within 12 months after randomization
    2. Transplanted organs (except corneal transplant performed more than 3 months prior to randomization)
    3. Major ischemic event unrelated to GCA within 12 weeks of Screening
    Exclusions Related to Prior or Concomitant Therapy
    4. Concurrent enrollment in another clinical study, with the exception of observational studies
    5. Previous treatment with KPL-301
    6. Treatment with any investigational drug therapy within 4 weeks or 5 half-lives of the study agent, whichever was longer, prior to Screening
    7. Any cell-depleting biological therapies (e.g., anti-CD20) within 12 months prior to Day 0; or previous treatment with noncell-depleting biologic therapies (such as anti-tumor necrosis factor [TNF], anakinra, anti-Interleukin [IL]-6 receptor [e.g. tocilizumab], or abatacept) within 8 weeks (or 5 half-lives, whichever is longer) prior to Screening
    8. Treatment with alkylating agents within 12 weeks prior to Screening
    9. Intramuscular, IV corticosteroids within 4 weeks prior to Screening
    10. Receipt of live (attenuated) vaccine within the 4 weeks before Day 0
    11. Treatment with hydroxychloroquine, cyclosporine A, azathioprine, or mycophenolate mofetil (MMF) within 4 weeks of Screening Relating to Medical History
    12. Female subjects who are pregnant, intending to become pregnant, or are breastfeeding
    13. Any condition that, in the opinion of the Investigator, could interfere with evaluation of KPL-301 or interpretation of subject safety or confound the results of the study
    14. Known history of allergy or reaction to any component of the KPL-301 or placebo formulation or to any other biologic therapy or prednisone or any of its excipients
    15. Active, untreated or partially treated latent tuberculosis (TB)
    16. Clinically significant active infection including signs/symptoms suggestive of infection, any significant recurrent or chronic infection (including positive hepatitis C virus antibody [HCVAb]), or any episode of infection requiring hospitalization or treatment with IV antibiotics within 12 weeks before Screening. Subjects with any opportunistic infection within 6 months before Screening will be excluded from the study.
    17. Subjects with chronic active hepatitis B infection as defined below will be excluded from the study:
     Hepatitis B surface antigen (HbsAg) positive
     Hepatitis B anti-core antibody positive but anti-surface antibody negative
    18. Subjects at a high risk of infection (e.g., history of hereditary or acquired immune deficiency disorder including a history of known human immunodeficiency virus [HIV] infection), a history of an infected joint prosthesis at any time with that prosthesis still in situ, leg ulcers, indwelling urinary catheter, or persistent or recurrent chest infections
    19. History of cancer within the last 10 years (20 years for breast cancer) except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured
    20. Evidence of clinically uncontrolled respiratory disease. The Investigator should review the data from subjects’ respiratory assessments including chest x-ray and pulmonary function tests (PFTs) performed within 12 weeks prior to Day 0. The subjects must have had values ≥ 60% of predicted for measurements performed and no uncontrolled lung disease. A subject’s medical regimen should not have been significantly intensified to control lung disease within 12 weeks prior to Day 0.
    21. History of chronic respiratory tract infections
    22. Congestive heart failure of New York Heart Association classification III or IV
    23. At screening blood tests, any of the following:
    a) Aspartate transaminase (AST) > 2 × upper limit of normal (ULN)
    b) Alanine transaminase (ALT) > 2 × ULN
    c) Hemoglobin < 75 g/L
    d) Neutrophils < 1.5 × 109/L
    e) Creatinine clearance (CrCl) <30 mL/min
    Criterios de exclusión generales
    1. Intervención de cirugía mayor en las 8 semanas previas a la selección o intervención de cirugía mayor programada en los 12 meses siguientes a la aleatorización
    2. Trasplante de órgano (a excepción del trasplante de córnea realizado más de 3 meses antes de la aleatorización)
    3. Episodio isquémico grave no relacionado con la ACG en las 12 semanas previas a la selección
    Exclusiones relacionadas con el tratamiento previo o concomitante
    4. Inclusión simultánea en otro estudio clínico, con la excepción de los estudios observacionales
    5. Tratamiento previo con KPL-301.
    6. Tratamiento con cualquier fármaco en investigación en las 4 semanas o 5 semividas del fármaco del estudio, lo que suponga más tiempo, antes de la selección.
    7. Cualquier tratamiento biológico de reducción celular (p. ej., anti-CD20) en los 12 meses previos al día 0; o tratamiento previo con fármacos biológicos sin reducción celular (como factor de necrosis tumoral [TNF], anakinra, anti-receptor de la interleucina [IL]-6 [p. ej., tocilizumab] o abatacept) en las 8 semanas (o 5 semividas, lo que suponga más tiempo) previas a la selección.
    8. Tratamiento con alquilantes en las 12 semanas previas a la selección.
    9. Corticosteroides por vía intramuscular o IV en las 4 semanas previas a la selección.
    10. Recepción de una vacuna de microorganismos vivos (atenuados) en las 4 semanas previas al día 0.
    11. Tratamiento con hidroxicloroquina, ciclosporina A, azatioprina o micofenolato mofetilo (MMF) en las 4 semanas previas a la selección.
    En relación con la historia clínica
    12. Mujeres embarazadas, que pretendan quedarse embarazadas o que estén amamantando.
    13. Cualquier trastorno que, en opinión del investigador, pueda interferir en la evaluación de KPL-301 o en la interpretación de la seguridad del paciente o confundir los resultados del estudio.
    14. Antecedentes conocidos de alergia o reacción a cualquier componente de la formulación de KPL-301 o placebo o a cualquier otro tratamiento biológico o prednisona o cualquiera de sus excipientes.
    15. Tuberculosis (TB) activa o latente no tratada o tratada parcialmente
    16. Infección activa clínicamente significativa, incluidos signos/síntomas indicativos de infección, cualquier infección recurrente o crónica importante (incluida la positividad del anticuerpo contra el virus de la hepatitis C [anti-VHC]) o cualquier episodio de infección que requiera hospitalización o tratamiento con antibióticos IV en las 12 semanas previas a la selección. Se excluirá del estudio a los pacientes con cualquier infección oportunista en los 6 meses previos a la selección.
    17. Se excluirá del estudio a los pacientes con hepatitis B activa crónica, tal como se define a continuación:
    • Antígeno de superficie del virus de la hepatitis B (HBsAg) positivo.
    • Anticuerpos positivos contra el antígeno central del virus de la hepatitis B, pero anticuerpos negativos contra el antígeno de superficie
    18. Pacientes con riesgo elevado de infección (p. ej., antecedentes de trastorno de inmunodeficiencia hereditaria o adquirida, incluidos antecedentes de infección conocida por el virus de la inmunodeficiencia humana [VIH]), antecedentes de una prótesis articular infectada en cualquier momento con esa prótesis todavía in situ, úlceras en las piernas, sonda urinaria permanente o infecciones pulmonares persistentes o recurrentes.
    19. Antecedentes de cáncer en los últimos 10 años (20 años en el caso del cáncer de mama), excepto carcinoma basocelular y espinocelular de piel o carcinoma in situ de cuello uterino tratado y considerado curado.
    20. Signos de enfermedad respiratoria clínicamente no controlada. El investigador deberá revisar los datos de las evaluaciones respiratorias de los pacientes, incluidas las radiografías de tórax y las pruebas de función pulmonar (PFP) realizadas en las 12 semanas previas al día 0. Los pacientes deberán haber tenido valores ≥ 60% del valor teórico en las mediciones realizadas y sin enfermedad pulmonar no controlada. El tratamiento médico del paciente no debe haberse intensificado significativamente para controlar la neumopatía en las 12 semanas previas al día 0.
    21. Antecedentes de infecciones respiratorias crónicas
    22. Insuficiencia cardíaca congestiva de clase III o IV de la New York Heart Association.
    23. En los análisis de sangre de selección, cualquiera de lo siguiente:
    a) Aspartato transaminasa (AST) > 2 veces el límite superior de la normalidad (LSN)
    b) Alanina transaminasa (ALT) > 2 veces el LSN
    c) Hemoglobina < 75 g/l
    d) Neutrófilos < 1,5 x 109/l
    e) Aclaramiento de creatinina (CrCl) < 30 ml/min
    E.5 End points
    E.5.1Primary end point(s)
    Time from start of double-blind treatment until the first flare occurring within the first 26-weeks of the double-blind period
    El tiempo transcurrido desde el inicio del tratamiento doble ciego hasta la primera exacerbación que se produzca en el período de 26 semanas
    E.5.1.1Timepoint(s) of evaluation of this end point
    Appro. 18 months after the start of the study
    Aprox. 18 meses después del inicio del estudio
    E.5.2Secondary end point(s)
    Time from start of double-blind treatment until the first flare occurring within the double-blind period
    * Percentage of subjects at Week 26 with normal ESR
    * Percentage of subjects at the end of double-blind period with normal ESR
    * Percentage of subjects at Week 26 with normal CRP
    * Percentage of subjects at the end of double-blind period with normal CRP
    * Time to steroid dose of zero
    * Cumulative steroid dose at Week 26 and at the end of the double-blind treatment period
    * Change in clinical GCA assessments (including NRS and FACIT) over time
    El tiempo transcurrido desde el inicio del tratamiento doble ciego hasta la primera exacerbación:
    • Porcentaje de pacientes en la semana 26 con VSG normal
    • Porcentaje de pacientes al final del tratamiento aleatorizado con VSG normal
    • Porcentaje de pacientes en la semana 26 con CRP normal
    • Porcentaje de pacientes al final del tratamiento aleatorizado con CRP normal
    • Tiempo hasta la dosis de esteroides de cero
    • Dosis acumulada de esteroides en la semana 26 y al final del período de tratamiento doble ciego
    • Variación de las evaluaciones clínicas de la ACG (incluidas la EVN y la FACIT) a lo largo del tiempo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Appro. 18 months after the start of the study
    Aprox. 18 meses después del inicio del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    E.6.10Pharmacogenetic No
    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 trial2
    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 EEA39
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Croatia
    Estonia
    Germany
    Ireland
    Italy
    Netherlands
    New Zealand
    Poland
    Serbia
    Slovenia
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    F.4.2.2In the whole clinical trial 60
    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)
    Based on the results of analysis, all subjects will be offered open-label KPL-301 in the OLE portion of the trial, or the study will be discontinued.
    Según los resultados del análisis, a todos los sujetos se les ofrecerá KPL-301 de etiqueta abierta en la parte de la extension abierta (EA) del ensayo, o se descontinuará del estudio.
    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 Decision2018-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-19
    P. End of Trial
    P.End of Trial StatusOngoing
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