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    Summary
    EudraCT Number:2018-004293-10
    Sponsor's Protocol Code Number:IM011084
    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:2019-06-11
    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 number2018-004293-10
    A.3Full title of the trial
    A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Multiple Doses of BMS-986165 in Subjects with Active Psoriatic Arthritis (PsA)
    Estudio multicéntrico, aleatorizado, controlado con placebo, con doble enmascaramiento, para evaluar la eficacia y la seguridad de dosis múltiples de BMS-986165 en sujetos con artritis psoriásica (AP) activa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of BMS-986165 Compared with Placebo in Subjects with Active Psoriatic Arthritis (PsA)
    Eficacia y Seguridad de BMS-986165 comparado con Placebo en Sujetos con Artritis Psoriásica (AP) Activa
    A.4.1Sponsor's protocol code numberIM011084
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb Research and Development
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameBMS-986165
    D.3.2Product code BMS-986165
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBMS-986165
    D.3.9.1CAS number 1609392-28-0
    D.3.9.3Other descriptive nameBMS986165
    D.3.9.4EV Substance CodeSUB180283
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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.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 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 nameBMS-986165
    D.3.2Product code BMS-986165
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBMS-986165
    D.3.9.1CAS number 1609392-28-0
    D.3.9.3Other descriptive nameBMS986165
    D.3.9.4EV Substance CodeSUB180283
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Stelara
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameUstekinumab
    D.3.4Pharmaceutical form Solution for infusion
    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 INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    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
    Psoriatic Arthritis
    Artritis Psoriásica
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis (PsA) is a chronic inflammatory disease
    Artritis psoriásica (AP) es una enfermedad inflamatoria crónica
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the dose-response relationship of BMS-986165 (6 or 12 mg once daily [QD]) at Week 16 in the treatment of subjects with active PsA
    Evaluar la relación dosis-respuesta de BMS-986165 (6 o 12 mg una vez al día [QD]) en la semana 16 en el tratamiento de sujetos con AP activa
    E.2.2Secondary objectives of the trial
    Assess the dose-response relationship of BMS-986165 (6 or 12 mg QD) at Week 16 in daily functional activities
    Assess the dose-response relationship of BMS-986165 (6 or 12 mg QD) at Week 16 in reducing PSO severity
    Assess the dose-response relationship of BMS-986165 (6 or 12 mg QD) at Week 16 in Patient-reported Outcomes
    Evaluar la relación dosis-respuesta de BMS-986165 (6 o 12 mg QD) en la semana 16 en las actividades funcionales diarias.
    Evaluar la relación dosis-respuesta de BMS-986165 (6 o 12 mg QD) en la semana 16 en cuanto a reducción de la gravedad de la PSO.
    Evaluar la relación dosis-respuesta de BMS-986165 (6 o 12 mg QD) en la semana 16 en cuanto a resultados comunicados por los pacientes (PRO)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed Written Informed Consent
    2.Type of Participant and Target Disease Characteristics
    Diagnosed with PsA for at least 6 months before screening, and who meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening.
    Subjects either (i) cannot have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 TNF-inhibitor (TNFi-experienced). Failure is defined as lack of response or loss of response with at least 3 months of therapy with an approved dose of a TNFi, as judged by the investigator. Failure must have occurred at least 2 months prior to Day 1.
    Subjects have at least 1 confirmed ≥ 2 cm lesion of plaque psoriasis at screening.
    Subjects have active arthritis as shown by a minimum of ≥ 3 swollen joints and ≥ 3 tender joints (66/68 joint counts) at screening and Day 1.
    High sensitivity C-reactive protein (hsCRP) ≥ 3mg/L at screening.
    If on a conventional non-biologic DMARD (eg MTX, leflunomide, sulfasalazine or hydroxychloroquine) subjects can only take 1 DMARD. The DMARD must have been used for at least 3 months with a stable dose for at least 28 days prior to Day 1.
    Have failed or been intolerant to at least 1 non-biologic DMARD (or had to stop because of pregnancy or lactation but still eligible for the trial), NSAID and/or corticosteroid.
    If using an NSAID, the dose must be stable for at least 14 days before Day 1 and consistent with labeling recommendations.
    If using oral corticosteroids (≤ 10 mg/day prednisone equivalent), the dose must be stable for at least 14 days before Day 1.
    Concurrent topical therapy for plaque psoriasis must have been stable for at least 14 days before Day 1.
    3.Age and Reproductive Status
    Men and women aged ≥18 years at screening.
    Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.
    Women must not be pregnant, lactating, breastfeeding or be planning pregnancy during the study period.
    Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs plus 5 half-lives of study drug plus 30 days (duration of ovulatory cycle) post-treatment completion. Therefore in Part A WOCBP must agree to follow instructions for methods of contraception for 33 days post-treament completion while in Part B WOCBP must agree to follow instructions for methods of contraception for 190 days post-treatment completion.
    Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment plus 5 half-lives of the study treatment plus 90 days post-treatment completion Therefore in Part A, males who are sexually active with WOCBP must agree to follow instructions for methods of contraception for 93 days post-treatment completion, while in Part B males must agree to follow instructions for methods of contraception for 250 days post-treatment completion.
    1.Haber firmado el consentimiento informado escrito
    2.Tipo de participante y características de la enfermedad objeto del estudio.
    Diagnóstico de AP al menos 6 meses antes de la selección y cumplir con los Criterios CASPAR para la clasificación de la artritis psoriásica en la selección
    Sujetos (i) que no hayan recibido tratamiento previo con fármacos biológicos, o bien (ii) en los que el tratamiento con un inhibidor del TNF haya fracasado o causado intolerancia. El fracaso se define como falta de respuesta o pérdida de respuesta tras un mínimo de tres meses de tratamiento con una dosis aprobada de un iTNF, a criterio del investigador. La falla debe haber ocurrido al menos dos meses antes del día 1.
    Los sujetos tienen al menos una lesión confirmada de ≥2 cm de psoriasis en placa en la selección.
    Los sujetos tienen artritis activa, como lo muestra un mínimo de ≥3 articulaciones inflamadas y ≥3 articulaciones sensibles (66/68 conteos de articulaciones) en la selección y el día 1.
    Proteína C reactiva de alta sensibilidad (hsCRP) ≥3 mg/l en la selección.
    Si se encuentran en tratamiento con un FAME no biológico convencional (por ejemplo, MTX, leflunomida, sulfasalazina o hidroxicloroquina), los sujetos solo pueden recibir un FAME. El FAME debe haberse utilizado durante un mínimo de tres meses con una dosis estable durante al menos 28 días antes del día 1.
    Sujetos en los que el tratamiento con al menos un FAME no biológico, AINE o corticosteroide haya fracasado o producido intolerancia (o que hayan tenido que abandonarlo por embarazo o lactancia, pero siguen siendo aptos para participar en el ensayo).
    Si se utiliza un AINE, la dosis debe ser estable durante al menos 14 días antes del día 1 y de acuerdo con las recomendaciones que constan en la información sobre el producto.
    Si se utilizan corticosteroides orales (≤10 mg/día de equivalente de prednisona), la dosis debe ser estable durante al menos 14 días antes del día 1.
    El tratamiento tópico concomitante para la psoriasis en placas debe haber sido estable durante al menos 14 días antes del día 1.
    3.Edad y estado reproductivo
    Hombres y mujeres mayores de 18 años en la selección.
    Las mujeres con capacidad de procrear (MCCDP) deben dar resultado negativo en una prueba de embarazo en suero o en orina (sensibilidad mínima de 25 UI/l o unidades equivalentes de HCG) dentro de las 24 horas previas al inicio del tratamiento del estudio.
    Las mujeres no deben estar embarazadas, amamantando o planeando un embarazo durante el periodo del estudio.
    Las mujeres con capacidad de procrear (MCCDP) deben comprometerse a seguir las instrucciones sobre métodos anticonceptivos durante el tratamiento con los fármacos del estudio más 5 semividas del fármaco del estudio más 30 días (duración del ciclo ovulatorio) tras finalizar el tratamiento. Por lo tanto, en la parte A las MCCDP deben comprometerse a seguir las instrucciones sobre métodos anticonceptivos durante los 33 días posteriores a la finalización del tratamiento, mientras que en la parte B las MCCDP deben comprometerse a seguir las instrucciones sobre métodos anticonceptivos durante los 190 días posteriores a la finalización del tratamiento.
    Los hombres que sean sexualmente activos con MCCDP deberán comprometerse a seguir las instrucciones sobre métodos anticonceptivos durante el tiempo en que reciban el tratamiento del estudio más 5 semividas del tratamiento del estudio más 90 días a partir de la finalización del tratamiento. Por lo tanto, en la parte A los hombres que sean sexualmente activos con MCCDP deberán comprometerse a seguir las instrucciones sobre métodos anticonceptivos durante 93 días a partir de la finalización del tratamiento, mientras que en la parte B los hombres deberán comprometerse a seguir las instrucciones sobre métodos anticonceptivos durante 250 días a partir de la finalización del tratamiento.
    E.4Principal exclusion criteria
    1)Target Disease Exceptions.Has non-plaque psoriasis at screening or Day 1.Has any other autoimmune condition such as rheumatoid arthritis.Has active fibromyalgia.
    2)Infectious/Immune-related.History or evidence of active infection and/or febrile illness within 7 days prior to Day 1. History of recent serious bacterial, fungal, or viral infections requiring hospitalization and intravenous antimicrobial treatment within 90 days prior to screening, or any infection requiring antimicrobial treatment within 15 days prior to Day 1.Any bacterial infection within the last 60 days prior to screening, unless treated and resolved with antibiotics, or any chronic bacterial infection.Received live vaccine(s) within 60 days prior to Day 1, or plans to receive a live vaccine during the study, or within 60 days after completing study treatment.Presence of herpes simplex lesions or herpes zoster at screening or Day 1.History of severe herpes zoster or severe herpes simplex infection.Evidence of, or test positive for, hepatitis B.Evidence of, or test positive for, hepatitis C virus. Positive for human immunodeficiency virus antibody at screening.Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject’s immune status.
    3)Any of the following tuberculosis criteria:History of active TB prior to screening visit, regardless of completion of adequate treatment.Signs or symptoms of active TB during screening.Any imaging of the chest obtained during the screening period, or anytime within 6 months prior to Screening with documentation, showing evidence of current active or old pulmonary TB.Latent TB infection defined as positive IFN gamma release assay, by QuantiFERON-TB Gold testing at screening, in the absence of clinical manifestations.
    4)Medical History and Concurrent Diseases.If the subject is biologic-experienced, the following exclusion criteria will apply:History of use of antibodies to IL-12, IL-17, or IL-23.TNF-inhibitor(s) within 2 months of Day 1.History of use of agents that modulate lymphocyte trafficking, or agents that modulate B cells or T cells. If the subject is biologic-naïve: has not received any biologic immunomodulatory treatment.Any major surgery within 4 weeks prior to Day 1, or any planned surgery for the first 52 weeks of the study.Has donated blood > 500 mL within 4 weeks prior to Day 1, or intends to donate blood during the course of the study. Drug or alcohol abuse within 6 months prior to Day 1. Any major illness/condition or evidence of an unstable clinical condition that will substantially increase the risk to the subject if he or she participates in the study.Unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months prior to screening, or a cardiac hospitalization within the 3 months prior to screening.Has uncontrolled arterial hypertension characterized by a systolic blood pressure > 160 mm Hg or diastolic BP > 100 mm Hg. Class III or IV congestive heart failure by New York Heart Association Criteria.History of cancer or lymphoproliferative disease within the previous 5 years.Any other sound medical, and/or social reason.Prior exposure to the investigational product.Has received any JAK inhibitors.Has received systemic non-biologic psoriasis medications and/or any systemic immunosuppressants therapy within 4 weeks prior to Day 1.Use of any opioid analgesic at average daily doses of > 30 mg/day of morphine or its equivalent or use of variable doses of any opiate analgesic within 6 weeks prior to Day 1.Has received phototherapy within 4 weeks prior to Day 1.Has used topical medications/treatments that could affect psoriasis evaluation within 2 weeks of Day 1.Use of shampoos that contain corticosteroids, coal tar, or vitamin D3 analogues within 2 weeks prior to Day 1.Has received any experimental therapy or new investigational agent within 30 days or 5 half-lives prior to Day 1 or is currently enrolled in an investigational study.
    5)Physical and Laboratory Test Findings.Absolute white blood cell (WBC) count < 3000/mm3 at screening.Absolute lymphocyte count < 500/mm3 at screening.Absolute neutrophil count < 1000/mm3 at screening.Platelet count < 100,000/mm3 at screening.Hemoglobin < 9 g/dL at screening.ALT and/or AST > 2x upperlimit of normal (ULN) at screening.Total, unconjugated, and/or conjugated bilirubin > 1.5x ULN at screening, except for any subject with a diagnosis of Gilbert’s syndrome.Estimated glomelular filtration rate (eGFR) < 45 mL/min .Any other significant laboratory or procedure abnormalities might place the subject at unacceptable risk for participation in this study.
    6)Allergies and Adverse Drug Reactions.
    7)Other Exclusion Criteria. Prisoners. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.Inability to comply with restrictions and prohibited activities/treatments Site personnel or their immediate family
    1)Excepciones relacionadas con la enfermedad.Sufre psoriasis no en placas en la selección o el D1.Sufre alguna otra afección autoinmune, como artritis reumatoide.Sufre fibromialgia activa.
    2)Relacionadas con infecciones/enfermedades inmunológicas.Historia/signos de infección activa o enfermedad febril en los 7d previos al D1.Historia de infecciones bacterianas, fúngicas o virales recientes que requieran hospitalización y tto antimicrobiano IV en los 90d previos a la selección, o cualquier infección que requiera tto antimicrobiano en los 15d previos al D1.Cualquier infección bacteriana en los 60d previos a la selección, a menos que se trate y resuelva con antibióticos, o cualquier infección bacteriana crónica.Haber recibido vacunas vivas en los 60d previos al D1, o tiene previsto recibir una vacuna viva durante el estudio o en los 60d posteriores a la finalización del tto.Presencia de lesiones por herpes simple o zóster en la selección o D1.Historia de infección grave por herpes zóster o simplex.Evidencia o prueba + de hepatitis B o virus de hepatitis C.Resultado + para el anticuerpo contra el virus de la inmunodeficiencia humana en la selección.Cualquier historia de estado/trastorno de inmunodeficiencia congénita o adquirida conocida o sospechada que pueda comprometer el estado inmunitario.
    3)Cualquiera de estos criterios de tuberculosis:Historia de TB activa antes de la visita de selección, independientemente de la finalización del tto adecuado.Signos/síntomas de TB activa durante la selección.Cualquier imagen del tórax obtenida durante el periodo de selección, o cualquier momento dentro de los 6m previos a la selección, que muestre signos de TB pulmonar activa o antigua.Infección latente de TB, definida como ensayo de liberación de interferón-gamma con resultado +, según QuantiFERON-TB Gold en la selección, en ausencia de manifestaciones clínicas.
    4)Historial médico y enfermedades concomitantes.Si ha recibido tto con fármacos biológicos: Historia de uso de anticuerpos contra IL-12, IL-17 o IL-23.Inhibidores del TNF en los 2m previos al D1.Historia de uso de agentes que modulen el tráfico de linfocitos o agentes que modulen las células B o T.Si no ha recibido tto con fármacos biológicos: no ha recibido ningún tto inmunomodulador biológico.Cualquier cirugía mayor en las 4s previas al D1, o cualquier cirugía programada para las primeras 52s del estudio.Haber donado >500ml de sangre en las 4s previas al D1, o tiene la intención de donar sangre durante el estudio.Abuso de drogas o alcohol, en los 6m previos al D1.Cualquier enfermedad/trastorno importante o signos de trastorno clínico inestable que vaya a aumentar sustancialmente el riesgo para el sujeto.Enfermedad cardiovascular inestable, definida como un deterioro clínico reciente en los 3m previos a la selección, u hospitalización cardiaca en los 3m previos a la selección.Sufre hipertensión arterial incontrolada, caracterizada por una presión arterial sistólica >160mm Hg o una PA diastólica >100mm Hg.Insuficiencia cardíaca congestiva de clase III o IV según los criterios de la New York Heart Association.Historia de cáncer o enfermedad linfoproliferativa en los 5a anteriores.Cualquier otra razón médica o social sólida.Exposición previa al producto en investigación.Ha recibido algún inhibidor JAK.Ha recibido medicamentos sistémicos para la psoriasis no biológicos o tto sistémico con inmunosupresores en las 4s previas al D1.Uso de cualquier analgésico opioide en dosis diarias medias de >30 mg/d de morfina o su equivalente o uso de dosis variables de cualquier analgésico opiáceo en las 6s previas al D1.Ha recibido fototerapia en las 4s previas al D1.Haber usado medicamentos/ttos tópicos que puedan afectar a la evaluación de la psoriasis en las 2s previas al D1.Uso de champús que contengan corticosteroides,alquitrán de hulla o análogos de la Vit D3 en las 2s previas al D1. Ha recibido algún tto experimental o nuevo agente en investigación en los 30d o 5 semividas previos al D1 o participa actualmente en un estudio de investigación.
    5)Resultados físicos y analíticos en la selección.Recuento absoluto de GB<3000/mm3.Recuento absoluto de linfocitos<500/mm3.Recuento absoluto de neutrófilos<1000/mm3.Recuento de plaquetas <100.000/mm3.Hemoglobina <9g/dl.ALT o AST>2v el límite superior de la normalidad.Bilirrubina total, no conjugada o conjugada>1,5xLSN, excepto para sujetos con diagnóstico de síndrome de Gilbert.Tasa de filtración glomerular estimada<45 ml/min.Cualquier otra anomalía significativa de laboratorio o procedimiento que pueda suponer un riesgo inaceptable en caso de participar en este estudio.
    6)Alergias/reacciones adversas a fármacos.
    7)Otros criterios.Prisioneros.Sujetos internados de manera forzosa para el tto de una enfermedad psiquiátrica/física.Incapacidad para cumplir con las restricciones y ttos/actividades prohibidos.Personal del sitio o su familia inmediata
    E.5 End points
    E.5.1Primary end point(s)
    ACR 20 response
    Respuesta ACR 20
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    Change from baseline in HAQ-DI score
    PASI 75 response
    Change from baseline in the Physical Component Summary (PCS) score of the SF-36 Questionnaire
    Cambio en la puntuación de HAQ-DI respecto al periodo basal.
    Respuesta PASI 75.
    Cambio en la puntuación del Resumen del componente físico (PCS) del cuestionario SF-36 respecto al periodo basal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    A lo largo del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 Yes
    E.8.2.3.1Comparator description
    Ustekinumab
    E.8.2.4Number of treatment arms in the trial5
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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
    Belgium
    Czech Republic
    Germany
    Hungary
    Italy
    Poland
    Russian Federation
    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
    LPLV
    Ultima Visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 153
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    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)
    After the patient has ended participation on the study, standard of care
    treatment by their physician is expected
    Después de que el paciente haya finalizado su participación en el estudio, se espera tratamiento de atención estándar por su médico.
    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 Decision2019-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-01
    P. End of Trial
    P.End of Trial StatusOngoing
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