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    Summary
    EudraCT Number:2021-003702-42
    Sponsor's Protocol Code Number:B7981058
    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:2022-05-12
    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 number2021-003702-42
    A.3Full title of the trial
    AN INTERVENTIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY AND SAFETY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
    ESTUDIO INTERVENCIONISTA EN FASE III, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE GRUPOS PARALELOS DE LA EFICACIA Y LA SEGURIDAD DE RITLECITINIB (PF-06651600) EN PARTICIPANTES ADULTOS CON COLITIS ULCEROSA ACTIVA DE MODERADA A GRAVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Placebo-controlled Efficacy and Safety Study with Ritlecitinib (PF-06651600) in Adults with Moderately to Severely Active UC
    Estudio en fase III controlado con placebo de la eficacia y la seguridad de ritlecitinib (PF-06651600) en adultos con CU activa de moderada a grave.
    A.4.1Sponsor's protocol code numberB7981058
    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 SponsorPfizer Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    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 nameRitlecitinib
    D.3.2Product code PF-06651600
    D.3.4Pharmaceutical form Capsule
    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 INNPF-06651600
    D.3.9.2Current sponsor codePF-06651600
    D.3.9.3Other descriptive namePF-06651600
    D.3.9.4EV Substance CodeSUB174316
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 nameRitlecitinib
    D.3.2Product code PF-06651600
    D.3.4Pharmaceutical form Capsule
    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 INNPF-06651600
    D.3.9.2Current sponsor codePF-06651600
    D.3.9.3Other descriptive namePF-06651600
    D.3.9.4EV Substance CodeSUB174316
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboCapsule
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Ulcerative Colitis (UC)
    Colitis ulcerosa de moderada a grave
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis is a chronic inflammatory condition of the gastrointestinal tract characterised by continuous inflammation that is localised to the colon
    La colitis ulcerosa es una afección inflamatoria crónica del tracto gastrointestinal caracterizada por una inflamación continua que se localiza en el colon.
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •Induction phase:
    To demonstrate whether ritlecitinib is superior to placebo, in participants with moderately to severely active UC, at Week 8 (I-8).

    •Maintenance phase:
    To evaluate the maintenance of efficacy of ritlecitinib over placebo, in participants with moderately to severely active UC, at Week 52 (M-44).
    Fase de inducción:
    Demostrar si ritlecitinib es superior al placebo en participantes con CU activa de moderada a grave en la semana 8 (I-8).

    Fase de mantenimiento:
    Evaluar el mantenimiento de la eficacia de ritlecitinib frente a placebo, en participantes con CU activa de moderada a grave, en la semana 52 (M-44).
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of ritlecitinib over placebo, in participants with moderately to severely active UC, on additional efficacy endpoints at Week 8 (I-8) and Week 52 (M 44).
    •To compare the efficacy of ritlecitinib versus placebo, in participants with moderately to severely active UC, on additional efficacy endpoints over time.
    •To compare the effect of ritlecitinib versus placebo on PROs over time.
    •To compare the effect of ritlecitinib versus placebo on disease biomarkers over time.
    •To characterize the safety of ritlecitinib versus placebo in participants with moderately to severely active UC
    •Evaluar la eficacia de ritlecitinib sobre placebo, en participantes con CU activa de moderada a grave, en criterios de valoración de la eficacia adicionales en la semana 8 (I-8) y la semana 52 (M-44).
    •Comparar la eficacia de ritlecitinib frente a placebo, en participantes con CU activa de moderada a grave, en criterios de valoración de la eficacia adicionales a lo largo del tiempo.
    •Comparar el efecto de ritlecitinib frente a placebo en los RNP a lo largo del tiempo.
    •Comparar el efecto de ritlecitinib frente a placebo en los biomarcadores de la enfermedad a lo largo del tiempo.
    •Caracterizar la seguridad de ritlecitinib frente a placebo en participantes con CU activa de moderada a grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age and Sex:
    1.At least ≥18 years of age (or the minimum country-specific age of consent if >18 years of age) at the Screening visit.
    •Refer to Appendix 4 for reproductive criteria for female (Section 10.4.2) participants.
    Type of Participant and Disease Characteristics:
    2.Documented onset of UC ≥3 months prior to baseline. A report supporting disease duration and extent (eg, proctosigmoiditis, left sided colitis, or pancolitis) based upon prior endoscopy including a biopsy report must be available in the source documentation prior to the Induction baseline visit.
    3.Moderately to severely active UC defined as
    •active disease beyond the rectum (active disease >15 cm from the anal verge at the screening endoscopy) and
    •by a modified Mayo score between 5 and 9, inclusive, with a rectal bleeding subscore ≥1 and an endoscopic subscore ≥2, determined at the Baseline visit
    The endoscopic subscore will be assessed centrally and must be available at the Induction baseline visit to derive the modified Mayo Score. Endoscopic assessment (colonoscopy or flexible sigmoidoscopy [if a colonoscopy was performed within 12 months before screening and the extent of disease is limited to left-sided colitis]) performed within 10 days of the Baseline visit will be accepted. Refer to exclusion criterion 3 for participants considered at risk for colorectal cancer for whom colonoscopy is required.
    4.Currently receiving any of the following treatments for UC are eligible, providing they have been and that they are anticipated to be on stable dose for the specified period of time:
    •Oral 5ASA or sulfasalazine: stable dose for at least 4 weeks prior to Induction baseline and during the duration of the treatment phase. If oral 5ASA treatment has been recently discontinued, it must have been stopped for at least 2 weeks prior to Induction baseline.
    •Oral corticosteroids (prednisone equivalent up to 25 mg/day; budesonide up to 9 mg/day; (see Appendix 15, Section 10.15): stable dose for at least 2 weeks prior to Induction baseline and during the duration of the treatment phase until initiation of corticosteroid treatment tapering. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to Induction baseline. Decreases in steroid use due to steroid-related adverse reactions are allowed.
    5.Must have an inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC:
    •IV or oral corticosteroids;
    •Immunosuppressants (AZA, 6MP, or MTX);
    •TNF inhibitors (eg, infliximab, adalimumab, or golimumab);
    •Integrin inhibitors (eg, vedolizumab).
    •IL12/23 inhibitor (eg, ustekinumab).
    •JAK inhibitors (eg, tofacitinib). NOTE: if participant is intolerant to a JAK inhibitor, they must not be included (See exclusion criterion 18).
    Note: the washout period for these medications is presented in Section 5.2 (exclusion criterion 17).
    6.Willing and able to comply with scheduled visits (including telemed/home visits, where allowed), treatment plan, laboratory tests, daily bowel movement diary, and other study procedures.
    Informed Consent:
    7.Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
    Los participantes serán aptos para ser incluidos en el estudio solo si cumplen todos los criterios siguientes:
    Edad y sexo:
    1. Tener al menos 18 años de edad (o la edad mínima específica del país de consentimiento si la edad es >18 años) en la visita de selección.
    •Consulte el Anexo 4 del protocolo para los criterios reproductivos para las participantes femeninas (sección 10.4.2 del protocolo).
    Tipo de paciente y características de la enfermedad:
    2. Aparición documentada de CU ≥3 meses antes del inicio. Debe estar disponible en la documentación original un informe que respalde la duración y el alcance de la enfermedad (p. ej., proctosigmoiditis, colitis del lado izquierdo o pancolitis) basándose en la endoscopia previa, incluido un informe de biopsia, antes de la visita inicial de la inducción.
    3. CU activa de moderada a grave, definida como
    •enfermedad activa más allá del recto (enfermedad activa a >15 cm del margen externo del ano en la endoscopia de la selección) y
    •según una puntuación de Mayo modificada entre 5 y 9, inclusive, con una subpuntuación de rectorragia ≥1 y una subpuntuación endoscópica ≥2, determinada en la visita inicial.
    La subpuntuación endoscópica se evaluará de forma centralizada y debe estar disponible en la visita inicial de la inducción para obtener la puntuación de Mayo modificada. Se aceptará la evaluación endoscópica (colonoscopia o sigmoidoscopia flexible [si se realizó una colonoscopia en los 12 meses anteriores a la selección y la extensión de la enfermedad se limita a la colitis del lado izquierdo]) realizada en los 10 días anteriores a la visita inicial. Consulte el criterio de exclusión 3 para participantes considerados en riesgo de cáncer colorrectal para los que se requiere colonoscopia.
    4. Si recibe actualmente cualquiera de los siguientes tratamientos para la CU es apto, siempre que haya estado y se prevea que estará recibiendo una dosis estable durante el periodo de tiempo especificado:
    •5 ASA oral o sulfasalazina: dosis estable durante al menos 4 semanas antes del inicio de la inducción y mientras dure la fase de tratamiento. Si se ha interrumpido recientemente el tratamiento oral con 5 ASA, se debe haber interrumpido durante al menos 2 semanas antes del inicio de la inducción.
    •Corticoesteroides orales (equivalente a prednisona hasta 25 mg/día; budesónida hasta 9 mg/día; (véase el Apéndice 15 del protocolo, Sección 10.15): dosis estable durante al menos 2 semanas antes del inicio de la inducción y durante la fase de tratamiento hasta el inicio de la reducción gradual del tratamiento con corticoesteroides. Si se han interrumpido recientemente los corticoesteroides orales, deben interrumpirse al menos 2 semanas antes del inicio de la inducción. Se permiten disminuciones del uso de corticoesteroides debido a reacciones adversas relacionadas con los corticoesteroides.
    5. Deben tener una respuesta inadecuada, pérdida de respuesta o intolerancia a al menos un tratamiento convencional para la CU:
    •Corticoesteroides orales o i.v.,
    •inmunodepresores (AZA, 6MP o MTX),
    •inhibidores del FNT (p. ej., infliximab, adalimumab y golimumab).
    •inhibidores de la integrina (p. ej., vedolizumab).
    •inhibidor de IL12/23 (p. ej., ustekinumab).
    •inhibidores de JAK (p. ej., tofacitinib). NOTA: si el participante es intolerante a un inhibidor de JAK, no debe incluirse (véase el criterio de exclusión 18).
    Nota: el periodo de reposo farmacológico de estos medicamentos se presenta en la sección 5.2 del protocolo (criterio de exclusión 17).
    6. Estar dispuesto y ser capaz de cumplir con las visitas programadas (incluidas las visitas de telemedicina y a domicilio, donde esté permitido), el plan de tratamiento, las pruebas analíticas, el diario de actividad intestinal y otros procedimientos del estudio.
    Consentimiento informado:
    7. Capacidad de otorgar consentimiento informado firmado, tal y como se describe en el Apéndice 1 del protocolo, lo que comprende el cumplimiento de los requisitos y las restricciones indicados en el formulario de consentimiento informado (FCI) y en este protocolo.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical Conditions:
    Medical Conditions Pertaining to UC
    1.Presence / evidence of
    •indeterminate colitis
    •microscopic colitis
    •ischemic colitis
    •infectious colitis
    •primary sclerosing cholangitis
    •colonic dysplasia
    •adenomas or neoplasia
    •clinical findings suggestive of Crohn’s disease (eg, fistulae, granulomas on biopsy);
    •clinical signs of fulminant colitis or toxic megacolon
    2.History of
    •bowel surgery within 6 months prior to Baseline,
    •known colonic stricture
    •colonic or small bowel obstruction or extensive small bowel resection (> 100 cm), or short bowel syndrome
    •colonic or small bowel stoma
    •hospitalized for UC related reason(s) within 4 weeks of Induction baseline visit.
    3.Meeting either of the 2 criteria below are considered at risk for colorectal cancer. The colonoscopy and pathology reports (if biopsies obtained) must be available in the source documentation:
    •If the participant is ≥50 years of age, and a colonoscopy has not been performed within 10 years of the first dose of study intervention, the colonoscopy at the screening visit is required to exclude adenomatous polyps. Participants with adenomatous polyps identified on screening endoscopy will be eligible after complete polypectomy and if no further short-term endoscopic follow-up is required per local guidelines.
    •If the participant has had extensive (ie, greater than left sided) colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for ≥10 years, regardless of age, and a colonoscopy has not been performed within 12 months of the first dose of study intervention, the colonoscopy at the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.
    4.Positive stool examinations for enteric pathogens, pathogenic ova or parasites, or presence of active enteric infections: known pathogenic bacterial, parasitic, fungal infections, including Clostridium difficile toxin at screening.
    Medical Conditions, Infection History
    5.General Infection History
    •clinically significant infections defined as those requiring hospitalization; opportunistic infections; requiring parenteral antimicrobial, antiviral (including biologic treatment), antiparasitic, antiprotozoal, or antifungal therapy, currently or within 6 months of Baseline
    •history of any infection requiring oral antimicrobial, antiviral (including biologic treatment), antiparasitic, antiprotozoal, or antifungal therapy within 2 weeks of Induction Baseline
    •history of any infection or chronic/recurrent infections otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
    6.Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis (TB) as evidenced by the following:
    •IGRA test: a positive QuantiFERON® TB Gold Plus (QFT-G, completed by central laboratory) or a positive or borderline T-SPOT®.TB (performed at local laboratory in Japan or those countries where local guidance require T-SPOT®.TB testing) during screening. If the IGRA test results are indeterminate/borderline, the test should be repeated. If the results of the repeat test are indeterminate/borderline, a purified protein derivative (PPD) test may be substituted for the IGRA test only with the approval from the Pfizer medical monitor on a case-by-case basis. (Participants with a history of Bacille Calmette Guérin [BCG] vaccination must have a negative IGRA test). Refer to section 10.2.1 for additional details on TB testing.
    •A positive QFT-G test or positive or borderline T-SPOT.TB® (T-SPOT test) performed within 12 weeks prior to screening.
    •Chest imaging is required if QFT-G is positive or T-SPOT is positive or borderline or if the participant has been previously treated for latent or active TB and is to be performed according to local standards of care or country-specific guidelines. Chest imaging performed 12 weeks prior to screening showing no active TB will be accepted with a copy of the report available in the source document.
    Note: Participants who have previously been adequately treated for latent or active TB (according to WHO/regional or local country recommendations by appropriately qualified personnel as defined by local practice) may be enrolled. Neither a QFT-G test, nor a T-SPOT test nor a PPD test is needed provided the treatment, including details of the previous course of therapy (eg., medication(s) used, dose, and duration) is well documented in the participant’s medical records and/or source documentation prior to enrolment in the study.
    Further exclusion criteria are detailed in the protocol.
    Los participantes serán excluidos del estudio si cumplen alguno de los criterios siguientes:
    Enfermedades:
    Enfermedades relacionadas con la CU
    1. Presencia/evidencia de
    • colitis indeterminada
    • colitis microscópica
    • colitis isquémica
    • colitis infecciosa
    • colangitis esclerosante primaria
    • displasia de colon
    • adenomas o neoplasia
    • hallazgos clínicos indicativos de enfermedad de Crohn (p. ej., fístulas, granulomas en la biopsia);
    •signos clínicos de colitis fulminante o megacolon tóxico
    2. Antecedentes de
    • cirugía intestinal en los 6 meses anteriores al inicio,
    • estenosis conocida del colon
    • obstrucción del colon o del intestino delgado o resección extensa del intestino delgado (>100 cm) o síndrome del intestino corto
    • estoma colónico o del intestino delgado
    • hospitalizado(s) por motivos relacionados con la CU en las 4 semanas anteriores a la visita inicial de la inducción.
    3. El cumplimiento de cualquiera de los 2 criterios siguientes se considera en riesgo de cáncer colorrectal. Los informes de colonoscopia y anatomopatología (si se obtienen biopsias) deben estar disponibles en la documentación fuente:
    •Si el participante tiene ≥50 años de edad y no se ha realizado una colonoscopia en los 10 años anteriores a la primera dosis de la intervención del estudio, se requiere la colonoscopia en la visita de selección para excluir los pólipos adenomatosos. Los participantes con pólipos adenomatosos identificados en la endoscopia de selección serán aptos después de una polipectomía completa y si no se requiere más seguimiento endoscópico a corto plazo según las directrices locales.
    • Si el participante ha tenido colitis extensa (es decir, mayor que en el lado izquierdo) durante ≥8 años o enfermedad limitada al lado izquierdo del colon (es decir, distal a flexión esplénica) durante ≥10 años, independientemente de la edad, y no se ha realizado una colonoscopia en los 12 meses anteriores a la primera dosis de la intervención del estudio, se requiere la colonoscopia en la visita de selección para realizar una estudio de displasia. Se excluirá a los participantes con displasia o cáncer identificados en las biopsias.
    4. Exámenes de heces positivos para patógenos entéricos, huevos o parásitos patógenos, o presencia de infecciones entéricas activas: infecciones bacterianas, parasitarias y fúngicas patógenas conocidas, incluida la toxina de Clostridium difficile en la selección.
    Enfermedades, antecedentes de infección
    5. Antecedentes generales de infección
    •Infecciones clínicamente significativas definidas como aquellas que requieren hospitalización; infecciones oportunistas; que requieren tratamiento antimicrobiano, antiviral (incluido el tratamiento biológico), antiparasitario, antiprotozoario o antifúngico parenteral, actualmente o en los 6 meses anteriores al inicio del estudio
    •Antecedentes de cualquier infección que requiera tratamiento antimicrobiano, antivírico (incluido el tratamiento biológico), antiparasitario, antiprotozoario o antifúngico por vía oral en las 2 semanas anteriores al inicio de la inducción
    •Antecedentes de cualquier infección o infecciones crónicas/recurrentes que el investigador considere que pueden exacerbarse por participar en el estudio.
    6. Tener indicios o antecedentes de infección de tuberculosis (TB) activa o latente por Mycobacterium tuberculosis sin tratar o tratada inadecuadamente, según lo siguiente:
    •PRUEBA IGRA: Un resultado positivo de QuantiFERON®‐TB Gold Plus (QFT-G) (completado por el laboratorio central) O un resultado positivo o límite para TSPOT ®.TB (realizado en el laboratorio local en Japón o aquellos países en los que las directrices locales requieren pruebas T-SPOT®.TB) durante la selección. Si los resultados de IGRA son indeterminados/límite, debe repetirse la prueba. Si el resultado de la prueba repetida es indeterminado/límite, una prueba de derivado proteico purificado (PPD) se podrá sustituir por la prueba IGRA únicamente con la aprobación por parte del monitor médico de Pfizer valorando cada caso individualmente. (Los participantes con antecedentes de vacunación con bacilo de Calmette Guérin [BCG] deben tener una prueba IGRA negativa). Consulte la sección 10.2.1 del protocolo para más detalle sobre las pruebas de TB.
    •Una prueba de QFT-G positiva o positiva o límite para T-SPOT.TB® (prueba de TSPOT) realizada en las 12 semanas anteriores a la selección.
    •Se requieren imágenes torácicas si QFT-G es positivo o T-SPOT es positivo o límite, o si el participante ha sido tratado previamente para la TB latente o activa y se debe realizar de acuerdo con las normas asistenciales locales o las directrices específicas del país. Las imágenes torácicas realizadas 12 semanas antes de la selección que muestren ausencia de TB activa se aceptarán con una copia del informe disponible en el documento fuente.
    Puede consultar el resto de criterios de exclusión en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Induction Phase
    Clinical Remission
    Maintenance Phase
    Clinical Remission
    Fase de inducción
    Remisión clínica

    Fase de mantenimiento
    Remisión clínica
    E.5.1.1Timepoint(s) of evaluation of this end point
    Induction Phase
    Week 8
    Maintenance Phase
    Week 52
    Fase de inducción
    Semana 8
    Fase de mantenimiento
    Semana 52
    E.5.2Secondary end point(s)
    Induction phase:
    •Endoscopic improvement at Week 8 (I-8).
    •Endoscopic-histologic mucosal improvement at Week 8 (I-8) .
    Maintenance phase:
    •Endoscopic improvement at Week 52 (M-44).
    •Steroid-free clinical remission at Week 52 (M-44).
    •Endoscopic-histologic mucosal improvement at Week 52 (M 44).
    Fase de inducción:
    • Mejora endoscópica en la semana 8 (I-8).
    • Mejora endoscópicahistológica de la mucosa en la semana 8 (I-8).
    Fase de mantenimiento:
    • Mejora endoscópica en la semana 52 (M-44).
    • Remisión clínica sin corticoesteroides en la semana 52 (M-44).
    •Mejora endoscópicahistológica de la mucosa en la semana 52 (M-44).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints are as specified above
    Los estimados se indican arriba
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    China
    India
    Israel
    Japan
    Korea, Republic of
    Mexico
    South Africa
    Taiwan
    United States
    Austria
    France
    Poland
    Sweden
    Bulgaria
    Netherlands
    Spain
    Switzerland
    Czechia
    Germany
    Greece
    Italy
    Belgium
    Denmark
    Norway
    Russian Federation
    Serbia
    Slovakia
    Turkey
    Ukraine
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    Último paciente última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days2
    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: 600
    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 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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 432
    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)
    None
    Ninguno
    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 Decision2022-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-11-11
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