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    Summary
    EudraCT Number:2016-003936-19
    Sponsor's Protocol Code Number:CLR_16_22
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-02-10
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-003936-19
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
    Estudio de Fase 2a aleatorizado, con doble enmascaramiento y controlado con placebo para evaluar la eficacia y la seguridad de tildrakizumab en sujetos con espondilitis anquilosante o espondiloartritis axial no radiológica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Patients with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
    Un estudio en Fase IIa para evaluar la eficacia y la seguridad de tildrakizumab en sujetos con espondilitis anquilosante activa o espondiloartritis axial no radiologica.
    A.4.1Sponsor's protocol code numberCLR_16_22
    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 SponsorSUN Pharmaceuticals Global FZE
    B.1.3.4CountryUnited Arab Emirates
    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 supportSun Pharmaceuticals Global FZE
    B.4.2CountryUnited Arab Emirates
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCorporacio Sanitaria Parc Tauli
    B.5.2Functional name of contact pointJordi Gratacos Masmitja
    B.5.3 Address:
    B.5.3.1Street AddressParc Tauli 1
    B.5.3.2Town/ citySabadell
    B.5.3.3Post code08208
    B.5.3.4CountrySpain
    B.5.4Telephone number0034680417532
    B.5.6E-mailjgratacos@tauli.cat
    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 nameTildrakizumab
    D.3.2Product code MK-3222
    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 INNTildrakizumab
    D.3.9.1CAS number 1326244-10-3
    D.3.9.2Current sponsor codeMK-3222
    D.3.9.3Other descriptive nameAnti-Human Interleukin-23 Monoclonal Antibody
    D.3.9.4EV Substance CodeSUB130334
    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 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.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
    Ankylosing spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
    Espondilitis anquilosante y espondiloartritis axial no radiológica
    E.1.1.1Medical condition in easily understood language
    Type of chronic inflammatory arthritis involving the spine and/or sacroiliac joints.
    Un tipo de artritis crónica que afecta a la columna y/o a las articulaciones sacroilíacas
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Efficacy Objective (Part 1)
    - To evaluate the efficacy of tildrakizumab in subjects with AS or nr-axSpA, as measured by the proportion of subjects achieving Assessment of SpondyloArthritis international Society (ASAS) criteria defined as ≥ 40% improvement in 3 of 4 assessment domains (ASAS40) response criteria at Week 24.
    Primary Safety Objective (Parts 1 and 2)
    - To assess the safety/tolerability and immunogenicity of multiple-dose administration of tildrakizumab in subjects with AS or nr-axSpA.
    Objetivo de eficacia principal: Parte 1
    Evaluar la eficacia de tildrakizumab en sujetos con espondilitis anquilosante (EA) o espondiloartritis axial no radiológica (EspAax-nr), medida por la proporción de sujetos que alcancen una respuesta 40 en los criterios de la Sociedad internacional de evaluación de la espondiloartritis (ASAS) en la semana 24.
    Objetivo de seguridad principal: Partes 1 y 2
    Evaluar la seguridad/tolerabilidad y la inmunogenia de la administración de dosis múltiples de tildrakizumab a sujetos con EA o EspAax-nr.
    E.2.2Secondary objectives of the trial
    Secondary objectives (Parts 1 and 2):
    - To evaluate the efficacy of tildrakizumab in subjects with AS or nr-axSpA, as measured by the proportion of subjects achieving ASAS40 response criteria at Week 52, and ASAS20 response criteria at Weeks 24 and 52.
    - To characterize the PK of tildrakizumab in subjects with AS or nr-axSpA.
    Objetivos secundarios: Partes 1 y 2
    -Evaluar la eficacia de tildrakizumab en sujetos con EA o EspAax-nr, medida por la proporción de sujetos que alcancen una respuesta ASAS 40 en la semana 52, y una respuesta ASAS 20 en las semanas 24 y 52.
    -Caracterizar la farmacocinética (FC) de tildrakizumab en sujetos con EA o EspAax-nr.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has provided informed consent.
    2. Subject is ≥ 18 years of age at time of Screening.
    3. Definite AS based on the modified New York criteria (1984) with symptom duration of at least 3 months at Screening as defined by modified New York criteria (1984), or for nr-axSpA, a documented diagnosis of adult onset axial spondyloarthritis as defined by the specific ASAS criteria with at least 3 months symptom duration before Screening.
    4. Subjects with nr-axSpA must have active inflammation (MRI) on Screening and no radiographic sacroiliitis that fulfils the 1984 modified New York criteria.
    5. Active disease at Screening, defined as:
    − BASDAI score (0-10) of at least 4, and
    − Response to the BASDAI question of ‘How would you describe the overall level of AS neck, back or hip pain you have had?’ of 40 or more on the VAS (0-100 mm), despite maximum tolerated doses of nonsteroidal anti-inflammatory drugs (NSAIDs).
    6. Have either an inadequate response for axial symptoms to 30 days of optimal daily doses of at least 1 NSAID or intolerance to at least 2 NSAIDs as defined to include indigestion, heartburn, dizziness, headache, nausea, vomiting, constipation, diarrhea, decreased appetite, and/or rash.
    7. The following concomitant medications are allowed if the dosage remained stable for at least 4 weeks before the Baseline visit and during the study:
    − sulfasalazine (up to 3 g a day), in subjects who have been treated for at least 3 months prior to Baseline,
    − methotrexate (MTX) (up to 25 mg per week) with no change in route of administration and only in subjects who have been treated for at least 3 months prior to Baseline,
    − prednisone or prednisone equivalent (up to 10 mg per day).
    Tapering of any of these concomitant medications during the study is allowed only if there is toxicity (accompanied by recording of an AE on the electronic case report form [eCRF]); otherwise the dosage must remain the same throughout Part 1 of the study. Adjustment of concomitant medication is permitted throughout Part 2 (Week 25 to 52) as needed (PRN) per Investigator discretion and therapeutic needs of the subject.
    8. For subjects receiving NSAIDs (including PRN use): the subject must be on a stable dose for ≥ 2 weeks prior to initiation of IMP and be expected to maintain a stable dose for the first 24 weeks of the study, unless change in dosage is required due to toxicity.
    9. Subject has a negative test for tuberculosis (TB) within 4 weeks before initiating IMP, defined as:
    − a negative QuantiFERON® test,
    − AND a posterior-anterior and lateral chest radiogram performed within 3 months of Screening with no evidence of active TB (or of any other pulmonary infectious diseases).
    10. Subjects with a positive or 2 successive indeterminate QuantiFERON tests are allowed if they have all of the following:
    − no history of active TB or symptoms of TB,
    − if prior latent TB infection, the subject must have a history of adequate prophylaxis (per local standard of care),
    − if presence of latent TB is established, then treatment according to local country guidelines must have been followed for at least 4 weeks prior to inclusion in the study.
    A maximum of 2 QuantiFERON tests are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used.
    1. El sujeto ha prestado su consentimiento informado.
    2. El sujeto tiene ≥ 18 años de edad en el momento de la selección.
    3. EA definida según los criterios modificados de Nueva York (1984) con una duración de los síntomas de al
    menos 3 meses en la visita de selección según se define en los criterios modificados de Nueva York (1984) o
    para la EspAax-nr un diagnóstico documentado de espondiloartritis axial de inicio adulto según se define en los
    criterios ASAS específicos con una duración de los síntomas de al menos 3 meses antes de la visita de
    selección.
    4. Los sujetos con EspAax-nr deben presentar inflamación activa (RMN) en la visita de selección y no presentar
    sacroileítis radiológica que cumpla los criterios modificados de Nueva York (1984).
    5. Enfermedad activa en el momento de la selección, definida según:
     Índice de BASDAI (0-10) de al menos 4, y
     Respuesta a la pregunta del BASDAI de ¿Cómo describiría el grado global de dolor en cuello, espalda o
    caderas que ha tenido? de 40 o más en la EVA (0-100 mm), a pesar de las dosis toleradas máximas de
    antiinflamatorios no esteroides (AINE).
    6. Presentar bien una respuesta inadecuada para los síntomas axiales a los 30 días de las dosis diarias óptimas de al
    menos 1 AINE o intolerancia a por lo menos 2 AINE definida como dispepsia, pirosis, mareos, cefalea, náuseas,
    vómitos, estreñimiento, diarrea, disminución del apetito y/o erupción cutánea.
    7. Se permiten los siguientes medicamentos concomitantes si la dosis permaneció estable durante al menos 4
    semanas antes de la visita basal y durante el estudio:
     sulfasalacina (hasta 3 g al día), en los sujetos que han sido tratados durante al menos 3 meses antes del
    momento basal,
     metotrexato (MTX) (hasta 25 mg por semana) sin cambio en la vía de administración y solamente en los
    sujetos que han sido tratados durante al menos 3 meses antes del momento basal,
     prednisona o equivalente de prednisona (hasta 10 mg al día).
    Se permite la retirada gradual de cualquiera de estos medicamentos concomitantes durante el estudio solamente
    si existe toxicidad (acompañada del registro de un AA en el cuaderno de recogida de datos electrónico [CRDe]);
    de lo contrario, la dosis debe seguir siendo la misma a lo largo de la parte 1 del estudio. Se permite el ajuste de
    la medicación concomitante a lo largo de la parte 2 (semanas 25 a 52) a demanda (PRN) según el criterio del
    investigador y las necesidades terapéuticas del sujeto.
    8. Sujetos que reciban AINE (incluido el uso a demanda): el sujeto no podrá haber modificado la dosis en
    las ≥ 2 semanas previas al inicio la administración del MI, y se espera que no lo haga en las primeras
    24 semanas del estudio, a menos que sea necesario por motivos de toxicidad.
    9. Sujetos con resultado negativo de la prueba de tuberculosis (TB) en un plazo de 4 semanas antes de iniciar la
    administración del MI, definida como:
     un resultado negativo de la prueba QuantiFERON®,
     Y una radiografía de tórax lateral y postero-anterior realizada en un plazo de 3 meses desde la selección sin
    indicios de TB activa (u otras enfermedades infecciosas pulmonares).
    10. Podrán participar sujetos con resultado positivo en la prueba QuantiFERON en una ocasión o con resultados
    indeterminados en dos ocasiones sucesivas, si cumplen todo lo siguiente: sin antecedentes de TB activa o síntomas de TB, si presentan infección TB latente previa, los sujetos deben tener antecedentes de profilaxis adecuada (según el tratamiento de referencia local), si se determina la presencia de TB latente, entonces se debe haber seguido el tratamiento según las directrices nacionales durante al menos 4 semanas antes de la inclusión en el estudio.
    Se permiten un máximo de 2 pruebas QuantiFERON. Solamente se permite volver a hacer la prueba si el resultado de la primera es indeterminado; se utilizará entonces el resultado de la segunda prueba.
    E.4Principal exclusion criteria
    1. Radiographic evidence of total ankylosis of the spine (defined by syndesmophytes present on the lateral views of spinal radiographs at all intervertebral levels from T6 through S1; films will be read centrally).
    2. Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes.
    3. Active uveitis or symptomatic inflammatory bowel disease requiring therapy at Screening.
    4. Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition.
    5. Subject has an active infection or history of infections as follows:
    − any active infection for which systemic anti-infectives were used within 28 days prior to first IMP dose, with the last dose having been received within 7 days of Screening,
    − any serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first investigational product dose, with the last dose having been received within 7 days of Screening,
    − recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject.
    6. Major chronic inflammatory or connective tissue disease other than AS (e.g., psoriatic arthritis [PsA], rheumatoid arthritis, systemic lupus erythematosus, Lyme disease, and gout).
    7. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause this study to be detrimental to the subject.
    8. Subject has known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
    9. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
    10. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
    11. Subject has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous basal or squamous cell carcinoma, in situ cervical carcinoma, OR in situ breast ductal carcinoma.
    12. Subjects with a history of alcohol or drug abuse in the previous 2 years.
    Laboratory abnormalities
    13. Subject has laboratory abnormalities at Screening, including any of the following:
    − aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times the upper limit of normal (ULN),
    − creatinine ≥ 1.5 times ULN,
    − serum direct bilirubin ≥ 1.5 mg/dL,
    − white blood cell (WBC) count < 3.0 x 103/μL,
    − any other laboratory abnormality that, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.
    Washouts and non-permitted drugs
    14. Disease modifying anti-rheumatic drugs (DMARD) other than NSAIDs, MTX or sulfasalazine must be discontinued 4 weeks prior to randomization, except for leflunomide, which has to be discontinued for 8 weeks prior to randomization (in the absence of a washout with cholestyramine).
    15. Subject has used any of the following within 28 days of IMP initiation:
    − high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine),
    − parenteral corticosteroids including intramuscular or intraarticular administration,
    − live vaccines,
    − has a need for use of a live vaccine within 10 weeks of final dose of IMP.
    16. Use of commercially available or investigational biologic therapies for AS as follows:
    − use of more than 1 biologic treatment,
    − use of entanercept within 4 weeks, infliximab within 8 weeks, and all other anti-TNF therapy within 3 months prior to IMP initiation,
    − prior use of B cell and T cell depleting agents within 12 months of Screening,
    − use of any other investigational or commercially available biologic therapies for AS or nr-axSpA within 3 months or 5 half-lives (whichever is longer) prior to IMP initiation,
    − any prior use of secukimumab, ustekinumab, ixekizumab, brodalumab, or any drug including MK-3222 targeting interleukin (IL)-17, IL-23, or the IL-12/IL-23-shared p40 molecule.
    General
    17. Subject has known sensitivity to any of the products or any excipients to be administered during dosing.
    18. Female subjects of childbearing potential must agree to practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depo progesterone, or intrauterine device; and (2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (eg, condom) if not surgically sterile (ie, vasectomy).
    See protocol for further exclusion criteria
    1. Evidencia radiológica de anquilosis total de la columna vertebral (definida por sindesmofitos presentes en las vistas laterales de las radiografías de la columna vertebral en todos los niveles intervertebrales desde T6 hasta S1; las placas se leerán de forma centralizada).
    2. Sujetos a quienes se diagnostica fibromialgia o síndromes de dolor regional complejo.
    3. Uveitis activa o enfermedad inflamatoria sintomática que requiere tratamiento en la visita de selección.
    4. El sujeto tiene una intervención quirúrgica programada entre el momento basal y la evaluación de la semana 24 para una afección anterior al tratamiento.
    5. El sujeto tiene una infección activa o antecedentes de infecciones, como se indica a continuación: cualquier infección activa para la cual se utilizaron antiinfecciosos sistémicos en un plazo de 28 días antes de la administración de la primera dosis de MI, y habiendo recibido la última dosis en un plazo de 7 días desde la visita de selección, cualquier infección grave.
    6. Enfermedad inflamatoria crónica grave o enfermedad del tejido conjuntivo aparte de EA (p. ej., artritis psoriásica [APs], artritis reumatoide, lupus eritematoso sistémico, enfermedad de Lyme y gota).
    7. El sujeto presenta alguna afección médica concurrente o no controlada, enfermedad sistémica clínicamente significativa que, a criterio del investigador, podría hacer que este estudio fuera perjudicial para el sujeto.
    8. El sujeto presenta antecedentes de infección por el virus de la hepatitis B, de la hepatitis C, o de la inmunodeficiencia humana.
    9. El sujeto ha tenido un infarto de miocardio, una angina de pecho inestable o un ictus isquémico en los 6 meses previos a la primera administración de MI.
    10. El sujeto presenta alguna neoplasia maligna activa, incluidos los indicios de carcinoma basocelular o espinocelular, y el melanoma.
    11. El sujeto presenta antecedentes de neoplasia maligna en 5 años EXCEPTO carcinoma basocelular o espinocelular tratado y considerado curado, carcinoma de cuello uterino localizado o de mama ductal localizado.
    12. Sujetos con antecedentes de alcoholismo o drogadicción en los 2 años previos. Anomalías en los análisis de laboratorio
    13. El sujeto presenta anomalías de laboratorio en el momento de la selección, como cualquiera de las siguientes: Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) ≥ 2 veces el límite superior de la normalidad (LSN), creatinina ≥ 1,5 veces el LSN, bilirrubina directa sérica ≥ 1,5 mg/dl, recuento de leucocitos < 3,0 x 103/μl, Cualquier otra anomalía de laboratorio que, a criterio del investigador, evitará que el sujeto complete el estudio o interferirá en la interpretación de los resultados del estudio.
    14. Los fármacos antirreumáticos modificadores de la enfermedad (FARME) aparte de los AINE, MTX o sulfasalacina deben interrumpirse 4 semanas antes de la aleatorización, a excepción de la leflunomida, que tiene que ser interrumpida durante 8 semanas antes de la aleatorización (en ausencia de un reposo farmacológico con colestiramina).
    15. El sujeto ha utilizado cualquiera de los siguientes en los 28 días previos al inicio de la administración del MI: analgésicos opioides de alta potencia (p. ej., metadona, hidromorfona o morfina), corticoesteroides por vía parenteral incluida la administración por vía intramuscular o intraarticular, vacunas con virus vivos,ha tenido que utilizar una vacuna con virus vivos en las 10 semanas previas a la administración de la última dosis del MI.
    16. Uso de tratamientos biológicos en fase de investigación o disponibles en el mercado para la EA según se indica: Uso de más de 1 tratamiento biológico, Uso de etanercept en las 4 semanas, infliximab en las 8 semanas, y todos los otros tratamientos anti-FNT en los 3 meses previos al inicio del MI, tratamiento con supresores de los linfocitos B y T en las 12 semanas previas a la selección, uso de cualquier tratamiento biológico en fase de investigación o disponible en el mercado para la EA o la EspAax-nr dentro de los 3 meses o 5 semividas (el periodo que sea más largo) antes del inicio del MI, tratamiento previo con secukinumab, ustekinumab, ixekizumab, brodalumab o cualquier fármaco, incluido MK-3222, que actúe sobre las interleucinas (IL)-17 e IL-23 o sobre la molécula p40, que comparten las IL-12/IL-23.
    17. El sujeto tiene sensibilidad conocida a cualquiera de los productos o de los excipientes que se administrarán.
    18. Los sujetos de sexo femenino potencialmente fértiles deben acordar usar un doble método anticonceptivo, una combinación de los siguientes: (1) anticonceptivo oral, progesterona de liberación lenta o dispositivo intrauterino; y (2) un método de barrera (preservativo o diafragma). Los sujetos varones con parejas en edad fértil que utilicen anticonceptivos deberán utilizar un método de barrera (ej preservativo), a menos que hayan sido esterilizados por método quirúrgico (vasectomía). Véase el protocolo para mas criterios de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for efficacy will be the proportion of subjects who achieve ASAS40 at Week 24.
    La proporción de sujetos que alcancen una respuesta ASAS 40 en la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    Secondary endpoints will be
    - The proportion of subjects who achieve ASAS40 at Week 52
    - The proportion of subject who achieve ASAS20 at Weeks 24 and 52
    - Evaluation of PK parameters: area under the concentration-time curve (AUC), maximum concentration (Cmax), minimum concentration (Cmin), time of maximal concentration (tmax) and half-life (T1/2).
    Criterios de valoración subjetivos:
    -La proporción de sujetos que alcancen una respuesta ASAS 40 en la semana 52.
    -La proporción de sujetos que alcancen una respuesta ASAS 20 en las semanas 24 y 52.
    -La respuesta ASAS 20 se define como una mejoría de ≥ 20 % y mejoría absoluta ≥ 10 unidades respecto al momento basal en una EVA en ≥ 3 de los 4 dominios: Evaluación global del sujeto; dolor total de espalda;
    BASFI e inflamación. Además, sin deterioro del posible dominio restante.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ASAS40 at Week 52
    ASAS20 at Weeks 24 and 52
    PK samples for evaluation will be collected at timepoints detailed in the Schedule of Assessments in the protocol.
    ASAS40 en la semana 52
    ASAS20 en la semana 24 y 52
    Las muestras para evaluación serán recogidas en diferentes momentos en el calendario que figura en el 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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
    Evaluate immunogenicity following IMP discontinuation
    Evaluar la inmunogenia después de suspender el MI.
    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 No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Germany
    Hungary
    Mexico
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    UVUP
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 119
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 119
    F.4.2.2In the whole clinical trial 180
    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 study is planned to follow patients who complete the study, this will allow them to continue on tildrakizumab and will be a separate study. Patients who do not wish to continue into a long term follow up after completing the study will be able to move to any other available treatment at the time that they enter the 20 week follow up period and are no longer receiving treatment with tildrakizumab. There are no restrictions on treatment during this time.
    Un estudio de extensión a largo plazo ha sido planeado para hacer seguimiento a los estudios que completan el estudio, esto les permitirá continuar con tildrakizumab en un estudio separado. Los pacientes que no deseen continuar en un seguimiento a largo plazo después de completar el estudio serán transferidos a otros tratamientos disponibles cuando entren en el periodo de 20 semanas y no estén recibiendo tratamiento con tildrakizumab. No hay restricciones en el tratamiento durante este tiempo.
    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 Decision2017-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-04-08
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