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    Summary
    EudraCT Number:2017-000573-37
    Sponsor's Protocol Code Number:SHP647-303
    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:2017-12-19
    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 number2017-000573-37
    A.3Full title of the trial
    A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
    Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos sobre la eficacia y la seguridad de SHP647 como tratamiento de mantenimiento en sujetos con colitis ulcerosa de moderada a grave (FIGARO UC303)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).
    Ensayo clínico para determinar si el producto en investigación SHP647 es seguro y efectivo en el tratamiento de la Colitis Ulcerosa severa o moderada, comparado con un placebo (tratamiento sin medicamento), se usará un diseño de aleatorización y ciego (ni el médico ni los pacientes participantes sabrán si reciben el medicamento o el placebo( FIGARO UC 303).
    A.3.2Name or abbreviated title of the trial where available
    FIGARO UC 303
    A.4.1Sponsor's protocol code numberSHP647-303
    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 SponsorShire Human Genetic Therapies, 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 supportShire Human Genetic Therapies, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Human Genetic Therapies, Inc.
    B.5.2Functional name of contact pointMelanie Ivarsson
    B.5.3 Address:
    B.5.3.1Street Address300 Shire Way
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code SHP647
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnti-MAdCAM antibody
    D.3.9.2Current sponsor codeSHP647
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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.3.2Product code SHP647
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnti-MAdCAM antibody
    D.3.9.2Current sponsor codeSHP647
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    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
    Ulcerative colitis
    Colitis Ulcerosa
    E.1.1.1Medical condition in easily understood language
    Long-term condition that results in inflammation and ulcers of the colon and rectum
    Enfermedad crónica que produce inflamación y úlceras en el colon y el recto
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    The primary objective of the study is to evaluate the efficacy of SHP647 as maintenance treatment of remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe UC.
    El primer objetivo del estudio es evaluar la eficacia de SHP647 como tratamiento de mantenimiento de la remisión, basándose en una puntuación compuesta de síntomas comunicados por el paciente y en una endoscopia evaluada de forma centralizada, en sujetos con colitis ulcerosa (CU) de moderada a grave.
    E.2.2Secondary objectives of the trial
    The key secondary objectives of the study are as follows:
    • To evaluate the efficacy of SHP647 on endoscopic remission, based on centrally read endoscopy.
    • To evaluate the efficacy of SHP647 on clinical remission, based on composite score of patient-reported symptoms.
    • To evaluate the efficacy of SHP647 on maintenance of remission among subjects in remission at baseline of the SHP647-303 study, based on composite score of patient-reported symptoms and centrally read endoscopy.
    • To evaluate the efficacy of SHP647 on clinical response, based on composite score of patient-reported symptoms and centrally read endoscopy.
    • To evaluate the efficacy of SHP647 on mucosal healing, based on endoscopic and histological assessments.
    • To evaluate the efficacy of SHP647 on glucocorticoid free clinical remission.
    • To evaluate the efficacy of SHP647 on glucocorticoid free remission.
    Objetivos Secundarios fundamentales.
    Evaluar la eficacia de SHP647:
    • Sobre la remisión endoscópica, basándose en una endoscopia evaluada de forma centralizada.
    • Sobre la remisión clínica, basándose en una puntuación compuesta de síntomas comunicados por el paciente.
    • Sobre el mantenimiento de la remisión en los sujetos que estaban en remisión en la visita basal del estudio SHP647-303, sobre la base de una puntuación compuesta de síntomas comunicados por el paciente y una endoscopia evaluada de forma centralizada.
    • Sobre la respuesta clínica, basándose en una puntuación compuesta de síntomas comunicados por el paciente y una endoscopia evaluada de forma centralizada.
    • Sobre la curación de la mucosa, basándose en evaluaciones endoscópicas e histológicas.
    • Sobre la remisión clínica sin glucocorticoides.
    • Sobre la remisión sin glucocorticoides.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study.
    1. Subjects and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
    2. Subjects must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
    3. Subjects must have completed the 12 week induction treatment period from study SHP647 301 or SHP647-302.
    4. Subjects must have achieved clinical response in induction study SHP647-301 or SHP647 302. Clinical response is defined as:
    1) A decrease from the induction study (SHP647 301 or SHP647-302) baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding ≥1 point or a subscore for rectal bleeding ≤1
    OR
    2) A decrease from the induction study (SHP647 301 or SHP647-302) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1.
    For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study SHP647 301 or SHP647 302.
    5. Subjects receiving any treatment(s) for UC described in Section 5.2.1 are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
    6. Subjects are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential. Males and females of reproductive potential who are sexually active must agree to use acceptable contraception (as described in Section 4.4 of the protocol) for the duration of the study.
    Los sujetos deben cumplir todos los criterios de inclusión siguientes para poder participar en el estudio.
    1. Los sujetos y/o sus padres o representantes legales deben tener conocimiento, capacidad y voluntad de cumplir plenamente los procedimientos y restricciones del estudio.
    2. Los sujetos deben ser capaces de otorgar por escrito, firmar y fechar (personalmente o mediante un representante legal) el consentimiento o asentimiento informado para poder participar en el estudio.
    3. Los sujetos deben haber completado el periodo de tratamiento de inducción de 12 semanas del estudio SHP647-301 o SHP647 302.
    4. Los sujetos deben haber alcanzado una respuesta clínica en el estudio de inducción SHP647-301 o SHP647-302. La respuesta clínica se define como:
    1) Una reducción de la puntuación compuesta de síntomas comunicados por el paciente mediante un diario electrónico y endoscopia evaluada de forma centralizada de al menos 2 puntos y al menos un 30 % con respecto al momento basal del estudio de inducción (SHP647 301 o SHP647-302), con una reducción acompañante de la subpuntuación de rectorragia ≥ 1 punto o una subpuntuación de rectorragia ≤ 1.
    O BIEN
    2) Una disminución de la puntuación Mayo total de al menos 3 puntos y al menos un 30 % con respecto al valor basal del estudio de inducción (SHP647 301 o SHP647-302), con una disminución acompañante en la subpuntuación de rectorragia de al menos 1 punto o una subpuntuación absoluta de rectorragia de 0 o 1.
    Para evaluar la elegibilidad, la respuesta clínica se determinará basándose en la endoscopia evaluada de forma centralizada efectuada durante la selección y en la semana 12 del estudio de inducción SHP647 301 o SHP647-302.
    5. Los sujetos tratados con cualquiera de los tratamientos de la CU que se describen en la sección 5.2.1 del protocolo son elegibles siempre que hayan recibido, o esté previsto que reciban, una dosis estable durante el periodo de tiempo especificado.
    6. Los sujetos son varones o mujeres no embarazadas ni lactantes que, en caso de tener actividad sexual, aceptan los requisitos de anticoncepción del protocolo, o bien son mujeres no fértiles. Los varones y las mujeres con capacidad reproductiva que mantengan relaciones sexuales deben comprometerse a utilizar métodos anticonceptivos aceptables durante todo el estudio.
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following exclusion criteria are met:
    1. Subjects who had major protocol deviation(s) (as determined by the sponsor) in induction study SHP647 301 or SHP647 302.
    2. Subjects who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in induction study SHP647-301 or SHP647-302.
    3. Subjects who are likely to require surgery for UC during the study period.
    4. Subjects are females who became pregnant during induction study SHP647-301 or SHP647 302, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue acceptable contraception methods through the conclusion of study participation (see Section 4.4).
    5. Male subjects who are planning to donate sperm must agree not to do so for the duration of the study and through 16 weeks after last dose of investigational product.
    6. Subjects who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
    7. Subjects who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
    8. Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty’s syndrome], or local active infection/infectious illness) that, in the investigator’s judgment, will substantially increase the risk to the subject if he or she participates in the study.
    9. Subjects with any other severe acute or chronic medical or psychiatric condition or laboratory or ECG abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    10. Subjects with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction study SHP647-301 or SHP647-302 and who are without a generally accepted course of treatment.
    11. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are sponsor employees directly involved in the conduct of the study.
    12. Subjects who are participating in or plan to participate in other investigational studies (other than induction study SHP647-301 or SHP647 302) during study SHP647-303.
    Se excluirá del estudio a los sujetos que cumplan alguno de los criterios siguientes:
    1. Sujetos con alguna desviación importante (a juicio del promotor) en el estudio de inducción SHP647 301 o SHP647 302.
    2. Sujetos que hayan suspendido de forma permanente el producto en investigación a causa de un AA, relacionado o no con el producto en investigación, en el estudio de inducción SHP647-301 o SHP647-302.
    3. Sujetos que probablemente necesiten cirugía para la CU durante el periodo del estudio.
    4. Mujeres que se quedaran embarazadas durante el estudio de inducción SHP647-301 o SHP647-302, mujeres que tengan intención de quedarse embarazadas durante el periodo del estudio y varones o mujeres con capacidad reproductiva que no acepten usar métodos anticonceptivos aceptables hasta el final de su participación en el estudio.
    5. Los varones que tengan previsto donar semen deben comprometerse a no hacerlo durante el estudio y en las 16 semanas siguientes a la última dosis del producto en investigación.
    6. Sujetos que, en opinión del investigador o el promotor, no vayan a cooperar o no sean capaces de cumplir los procedimientos del estudio.
    7. Sujetos que tengan una neoplasia maligna recién diagnosticada o recurrente (aparte de carcinoma basocelular cutáneo o carcinoma epidermoide extirpados o de carcinoma in situ del cuello uterino tratado y sin signos de recurrencia).
    8. Sujetos que hayan contraído cualquier enfermedad/trastorno importante o que presenten signos de algún proceso clínico inestable (p. ej., renal, hepático, hematológico, gastrointestinal (excepto la enfermedad estudiada), endocrino, cardiovascular, pulmonar, inmunológico [como el síndrome de Felty] o infección local activa/enfermedad infecciosa) que, a juicio del investigador, aumente considerablemente el riesgo para el sujeto en caso de participar en el estudio.
    9. Sujetos con cualquier otro trastorno médico o psiquiátrico grave, agudo o crónico, o cualquier alteración analítica o electrocardiográfica (del ECG) que pueda aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación, o que pueda interferir en la interpretación de los resultados del estudio y, en opinión del investigador, impida la participación del paciente.
    10. Sujetos con exposición conocida a Mycobacterium tuberculosis (TB) desde las pruebas de selección del estudio de inducción SHP647-301 o SHP647-302 y que no sigan un tratamiento generalmente aceptado.
    11. Miembros del personal del centro de investigación o sus familiares, o sujetos que sean empleados del promotor directamente implicados en la realización del estudio.
    12. Sujetos que participen o tengan previsto participar en otros estudios de investigación (aparte del estudio de inducción SHP647 301 o SHP647 302) durante el estudio SHP647-303.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is proportion of subjects in remission at the Week 52 visit. Remission is defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as follows:
    • stool frequency subscore of 0 or 1 with at least a 1-point change from induction (SHP647 301 or SHP647 302) baseline
    AND
    • rectal bleeding subscore of 0
    AND
    • endoscopic subscore of 0 or 1 (modified, excludes friability).
    El criterio de eficacia principal es la proporción de sujetos en remisión en la visita de la semana 52. La remisión se define como la puntuación compuesta de síntomas comunicados por el paciente en el diario e y la endoscopia evaluada de forma centralizada:
    • subpuntuación de frecuencia de las deposiciones de 0 o 1 con al menos una variación de 1 punto con respecto al momento basal del estudio de inducción (SHP647 301 o SHP647 302)
    Y
    • Subpuntuación de rectorragia de 0
    Y
    • Subpuntuación endoscópica de 0 o 1 (modificada, se excluye la friabilidad).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52 visit
    Visita de la semana 52
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints are as follows:
    • Proportion of subjects with endoscopic remission, as defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability), at the Week 52 visit.
    • Proportion of subjects with clinical remission as defined by stool frequency subscore of 0 or 1 with at least a 1-point change from induction study (SHP647-301 or SHP647-302) baseline in stool frequency subscore, and rectal bleeding subscore of 0, at the Week 52 visit.
    • Proportion of subjects with sustained remission, ie, in remission at the SHP647-303 Week 52 visit, among subjects who were in remission at the time of baseline in study SHP647 303. Remission is defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy, with stool frequency subscore of 0 or 1 with at least a 1-point change from induction study (SHP647-301 or SHP647-302) baseline, and rectal bleeding subscore of 0, and endoscopic subscore of 0 or 1 (modified, excludes friability).
    • Proportion of subjects with clinical response based on composite score at the Week 52 visit. Clinical response (composite) is defined as a decrease from induction study (SHP647-301 or SHP647 302) baseline in the composite score of subject-reported symptoms using daily e diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding ≥1 point or a subscore for rectal bleeding ≤1.
    • Proportion of subjects with mucosal healing, based on endoscopic and histologic assessment, at the Week 52 visit. Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of ≤2.
    • Proportion of subjects achieving glucocorticoid-free clinical remission at Week 52, among subjects using glucocorticoids in study SHP647-303 baseline. Glucocorticoid-free clinical remission is defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit. Clinical remission is defined as stool frequency subscore of 0 or 1 with at least a 1-point change from induction study (SHP647-301 or SHP647-302) baseline in stool frequency subscore, and rectal bleeding subscore of 0, at the Week 52 visit.
    • Proportion of subjects achieving glucocorticoid-free remission at Week 52, among subjects using glucocorticoids in study SHP647-303 baseline. Glucocorticoid-free remission is defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit. Remission is defined as a composite score of subject-reported symptoms using daily e diary and endoscopy, with stool frequency subscore of 0 or 1 with at least a 1-point change from induction study (SHP647-301 or SHP647-302) baseline, and rectal bleeding subscore of 0, and endoscopic subscore of 0 or 1 (modified, excludes friability).
    Criterios de valoración secundarios de la eficacia fundamentales:
    • Proporción de sujetos en remisión endoscópica, definida por una subpuntuación endoscópica de 0 o 1 (modificada, se excluye la friabilidad) evaluada de forma centralizada, en la visita de la semana 52.
    • Proporción de sujetos en remisión clínica, definida por una subpuntuación de 0 o 1 en la frecuencia de las deposiciones, con al menos una variación de 1 punto en la misma con respecto al momento basal del estudio de inducción (SHP647-301 o SHP647-302), y una subpuntuación de rectorragia de 0, en la visita de la semana 52.
    • Proporción de sujetos con remisión sostenida, es decir, en remisión en la visita de la semana 52 del SHP647-303, entre los sujetos que se encontraban en remisión en el momento basal del estudio SHP647 303. La remisión se define como la puntuación compuesta de síntomas comunicados por los pacientes en el diario electrónico y endoscopia evaluada de forma centralizada, con una subpuntuación de frecuencia de las deposiciones de 0 o 1 y una variación de al menos 1 punto con respecto al momento basal del estudio de inducción (SHP647-301 o SHP647 302), una subpuntuación de rectorragia de 0 y una subpuntuación endoscópica de 0 o 1 (modificada, se excluye la friabilidad).
    • Proporción de sujetos con respuesta clínica según la puntuación compuesta en la visita de la semana 52. La respuesta clínica (compuesta) se define como una reducción de la puntuación compuesta de síntomas comunicados por el paciente mediante un diario electrónico y endoscopia evaluada de forma centralizada de al menos 2 puntos y al menos un 30 % con respecto al momento basal del estudio de inducción (SHP647-301 o SHP647-302), con una reducción acompañante de la subpuntuación de rectorragia ≥ 1 punto o una subpuntuación de rectorragia ≤ 1.
    • Proporción de sujetos con curación de la mucosa, conforme a una evaluación endoscópica e histológica, en la visita de la semana 52. La curación de la mucosa se define por una subpuntuación endoscópica de 0 o 1 (modificada, se excluye la friabilidad) evaluada de forma centralizada y una puntuación de Geboes ≤ 2 evaluada de forma centralizada.
    • Proporción de sujetos que alcanzan la remisión clínica sin glucocorticoides en la semana 52 entre los sujetos que utilizaban glucocorticoides en el momento basal del estudio SHP647-303. La remisión clínica sin glucocorticoides se define como aquella remisión clínica que, además, no requiere tratamiento con glucocorticoides desde al menos 4 semanas antes de la visita de la semana 52. La remisión clínica se define por una subpuntuación de 0 o 1 en la frecuencia de las deposiciones, con al menos una variación de 1 punto en la misma con respecto al momento basal del estudio de inducción (SHP647-301 o SHP647-302), y una subpuntuación de rectorragia de 0, en la visita de la semana 52.
    • Proporción de sujetos que alcanzan la remisión sin glucocorticoides en la semana 52 entre los sujetos que utilizaban glucocorticoides en el momento basal del estudio SHP647-303. La remisión sin glucocorticoides se define como aquella remisión que, además, no requiere tratamiento con glucocorticoides desde al menos 4 semanas antes de la visita de la semana 52. La remisión se define como la puntuación compuesta de síntomas comunicados por los pacientes en el diario electrónico y endoscopia, con una subpuntuación de frecuencia de las deposiciones de 0 o 1 y una variación de al menos 1 punto con respecto al momento basal del estudio de inducción (SHP647-301 o SHP647-302), una subpuntuación de rectorragia de 0 y una subpuntuación endoscópica de 0 o 1 (modificada, se excluye la friabilidad).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52 visit
    Visita de la semana 52
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    Calidad de vida
    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 Yes
    E.8.2.3.1Comparator description
    25 mg o 75 mg SHP647
    25 mg or 75 mg SHP647
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA135
    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
    Austria
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Colombia
    Croatia
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Mexico
    Netherlands
    New Zealand
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Switzerland
    Ukraine
    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
    The Study Completion Date is defined as the date the final subject, across all sites, completes their final protocol-defined assessment. Please note that this includes the follow-up visit or contact, whichever is later.
    La fecha de finalización del estudio se define como la fecha en que el último sujeto, en todos los centros, completa su evaluación definitiva definida por el protocolo . Tenga en cuenta que ésto incluye la visita de seguimiento o contacto, lo que sea posterior
    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 months5
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 77
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 77
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 679
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescents (16-17 years)
    Adolescentes (16-17 años)
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 305
    F.4.2.2In the whole clinical trial 772
    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)
    At the end of the 52 week treatment period, the subject will either enter the LTS study (SHP647 304) or the 16 week safety follow up period.
    Al final del periodo de tratamiento de 52 semanas, el sujeto entrará bien al estudio SLP (SHP647 304) o bien a un periodo de seguimiento de la seguridad de 16 semanas
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-07-01
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