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    Summary
    EudraCT Number:2017-000572-28
    Sponsor's Protocol Code Number:SHP647-302
    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 number2017-000572-28
    A.3Full title of the trial
    A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)
    Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y la seguridad de SHP647 como tratamiento de inducción en sujetos con colitis ulcerosa moderada o grave (FIGARO UC 302)
    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 302).
    Estudio de investigación para determinar si un fármaco en investigación, SHP647, es seguro y eficaz en el tratamiento de la colitis ulcerosa de moderada a severa, en comparación con el placebo (tratamiento ficticio) - utilizando un diseño de estudio aleatorizado y ciego (el investigador y los pacientes no son conscientes de si reciben fármaco de estudio o placebo) (FIGARO UC 302).
    A.3.2Name or abbreviated title of the trial where available
    FIGARO UC 302
    FIGARO UC 302
    A.4.1Sponsor's protocol code numberSHP647-302
    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
    Afeccion prolongada que provoca inflamacion y ulceras en el colon y 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 in inducing remission,based on composite score of patient-reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).
    El objetivo principal del estudio es evaluar la eficacia de SHP647 para inducir la remisión, determinada mediante la puntuación combinada de los síntomas percibidos por el paciente y la evaluación centralizada de la endoscopia, en sujetos con colitis ulcerosa (CU) moderada o grave.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of SHP647 in achieving endoscopic remission, based on centrally read endoscopy.
    • To evaluate the efficacy of SHP647 in achieving clinical remission, based on composite score of patient-reported symptoms.
    • To evaluate the efficacy of SHP647 in inducing clinical response, based on composite score of patient-reported symptoms and centrally read endoscopy.
    • To evaluate the efficacy of SHP647 in achieving mucosal healing, based on endoscopic and histological assessment.
    • Evaluar la eficacia de SHP647 para conseguir la remisión endoscópica, determinada mediante la evaluación centralizada de la endoscopia.
    • Evaluar la eficacia de SHP647 para conseguir la remisión clínica, determinada mediante la puntuación combinada de los síntomas percibidos por el paciente.
    • Evaluar la eficacia de SHP647 para inducir la respuesta clínica, determinada mediante la puntuación combinada de los síntomas percibidos por el paciente y la evaluación centralizada de la endoscopia.
    • Evaluar la eficacia de SHP647 para conseguir la cicatrización de la mucosa, determinada mediante la evaluación endoscópica e histológica.
    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 must be between ≥16 and ≤80 years of age at the time of the signing of the informed consent/assent form.
    NOTE: Subjects <18 years of age must weigh ≥40 kg and must have body mass index (BMI) ≥16.5.
    2. Subjects must have a documented diagnosis (radiologic or endoscopic with histology) of UC for ≥3 months before screening. The following must be available in each subject’s source documentation:
    • A biopsy report to confirm the histological diagnosis.
    • A report documenting disease duration based upon prior colonoscopy.
    NOTE: If this documentation is not available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis is required during the screening period.
    3. Subjects must be willing to undergo a flexible sigmoidoscopy or colonoscopy (if preferred), including biopsy sample collection, during screening after all other inclusion criteria have been met.
    4. Subjects must have moderate to severe active UC, defined as a total Mayo score of ≥6, including a centrally read endoscopic subscore ≥2, rectal bleeding subscore ≥1, and stool frequency subscore ≥1 at baseline (Visit 2).
    5. Subjects must have evidence of UC extending proximal to the rectum (ie, not limited to proctitis).
    6. Subjects must have had an inadequate response to, or lost response to, at least 1 conventional treatment such as mesalamine (5 aminosalicylic acid [5-ASA]), glucocorticoids, immunosuppressants (azathioprine [AZA], 6 mercaptopurine [6 MP], or methotrexate [MTX]), or anti-TNF.
    Los sujetos deberán cumplir todos los criterios de inclusión siguientes pata poder participar en el estudio:
    1. Tener (el sujeto, o su progenitor o representante legal) entendimiento, capacidad y voluntad para cumplir plenamente con los procedimientos y las restricciones del estudio.
    2. Ser capaz de otorgar voluntariamente el consentimiento o asentimiento informado (según proceda) por escrito, firmado y fechado personalmente o a través de un representante legal, para participar en el estudio.
    3. Tener entre 16 y 80 años de edad en el momento de firmar el documento de consentimiento o asentimiento informado.
    NOTA: Los sujetos menores de 18 años deben tener un peso ≥ 40 kg y un índice de masa corporal (IMC) ≥ 16,5.
    4. Tener un diagnóstico (radiológico o endoscópico con examen histológico) documentado de CU desde al menos 3 meses antes de la selección. En la documentación original de todos los pacientes deberá constar lo siguiente:
    • Un informe de biopsia que confirme el diagnóstico histológico.
    • Un informe que confirme la duración de la enfermedad a partir de una colonoscopia anterior.
    NOTA: Si en el momento de la selección no se dispone de estos documentos, habrá que realizar una colonoscopia con biopsia para confirmar el diagnóstico durante el período de selección.
    5. Estar dispuesto a someterse a una sigmoidoscopia o colonoscopia (lo que sea preferible) con endoscopio flexible y obtención de muestra de biopsia durante la selección, una vez confirmado que se cumplen todos los demás criterios de inclusión.
    6. Tener una CU moderada o grave, definida por una puntuación ≥ 6 en el índice de Mayo con una subpuntuación de la evaluación centralizada de la endoscopia ≥ 2, de rectorragia ≥ 1 y de frecuencia de las deposiciones ≥ 1 en el momento basal (visita 2)
    7. Tener signos de extensión de la CU proximal al recto (es decir, no se limita a proctitis).
    8. Haber presentado una respuesta insuficiente, o pérdida de la respuesta, a al menos un tratamiento convencional como mesalamina (ácido 5 aminosalicílico [5-ASA]), glucocorticoides, inmunodepresores (azatioprina [AZA], 6 mercaptopurina [6 MP] o metotrexato [MTX]) o anti-TNF.
    9. Los sujetos que estén recibiendo alguno de los tratamientos para la UC que se describen en la sección 5.2.1 del protocolo podrán participar siempre que la dosis sea estable y esté previsto mantenerla durante el período de tiempo que se indica.
    10. Ser varón o mujer no embarazada ni en período de lactancia y, en caso de mantener relaciones sexuales, comprometerse a cumplir los requisitos de anticoncepción que exige el protocolo (excepto las mujeres que no estén en edad fértil). Los varones y mujeres en edad fértil 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 with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn’s disease.
    2. Subjects with colonic dysplasia or neoplasia.
    3. Subjects with past medical history or presence of toxic megacolon.
    4. Subjects with colonic stricture, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for UC during the treatment period.
    5. Subjects at risk for colorectal cancer must have a colonoscopy performed during the screening period with results available within 10 days before the baseline visit (Visit 2), unless the subject has had a colonoscopy within 1 year prior to screening, and any adenomatous polyps found at that examination have been excised.
    6. Subjects have participated in other investigational studies within either 30 days or 5 half lives of investigational product used in the study (whichever is longer) before baseline.
    7. Subjects with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis [subjects with C. difficile infection at screening may be allowed re-test after treatment], evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the subjects to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit (Visit 2).
    8. Subjects with abnormal chest x-ray findings at screening (Visit 1), such as presence of active tuberculosis (TB), general infections, heart failure, or malignancy.
    9. Subjects with evidence of active or latent infection with Mycobacterium tuberculosis (TB) who have not completed a generally accepted full course of treatment before randomization are excluded.
    10. Subjects with a pre-existing demyelinating disorder such as multiple sclerosis or new onset seizures, unexplained sensory motor, or cognitive behavioral, neurological deficits, or significant abnormalities noted during screening.
    11. Subjects with any unexplained symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on the targeted neurological assessment during the screening period.
    Se excluirá del estudio a los sujetos que cumplan alguno de los criterios siguientes:
    1. Sujetos con colitis indeterminada, colitis microscópica, colitis isquémica, colitis infecciosa o hallazgos clínicos / histológicos indicativos de enfermedad de Crohn.
    2. Sujetos con displasia o neoplasia colónica.
    3. Sujetos con antecedentes médicos o presencia de megacolon tóxico.
    4. Sujetos con estenosis del colon, antecedentes médicos de resección colónica, antecedentes de cirugía intestinal dentro de los 6 meses previos a la seleccion o que probablemente requieran cirugía para la CU durante el período de tratamiento.
    5. En los sujetos con riesgo de cáncer colorrectal, haberse sometido a una colonoscopia durante el período de selección y disponer de los resultados en los 10 días anteriores a la visita basal (visita 2), a menos que se haya efectuado una colonoscopia en el año anterior a la selección y se hayan extirpado todos los pólipos que se observaron en aquella exploración.
    6. Sujetos que hayan participado en otros estudios de investigación dentro de los 30 días o 5 semividas del producto en investigación utilizado en el estudio (el que sea mayor) antes del momento basal del estudio.ç
    7. Sujetos con infecciones entéricas activas (cultivo y sensibilidad positivos de heces), infección por Clostridium difficile o colitis pseudomembranosa [sujetos con infección por C. difficile en la seleccion pueden volver a someterse a la prueba después del tratamiento], evidencia de infección activa por citomegalovirus o Listeria monocytogenes, infecciones fúngicas invasivas activas conocidas como histoplasmosis o infecciones parasitarias, enfermedad subyacente clínicamente significativa que pudiese predisponer a los sujetos a infecciones, o antecedentes de infección grave (que requieran antibióticos parenterales y/u hospitalización ) dentro de las 4 semanas previas a la visita basal (visita 2).
    8. Sujetos con hallazgos anormales en la radiografía de tórax durante la seleccion (Visita 1), como presencia de tuberculosis activa (TB), infecciones generales, insuficiencia cardíaca o malignidad.
    9. Se excluyen los sujetos con evidencia de infección activa o latente con Mycobacterium tuberculosis (TB) que no hayan completado un curso completo de tratamiento generalmente aceptado antes de la aleatorización.
    10. Sujetos con una enfermedad desmielinizante preexistente como esclerosis múltiple, convulsiones o déficits neurológicos sensitivomotores o cognitivo-conductuales de nueva aparición o anomalías significativas observadas durante la selección.
    11. Sujetos con cualquier síntoma no justificado indicativo de leucoencefalopatía multifocal progresiva (LMP) en la exploración neurológica dirigida que se realiza en el período de selección.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects in remission at the Week 12 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 baseline
    AND
    • rectal bleeding subscore of 0
    AND
    • endoscopic subscore of 0 or 1 (modified, excludes friability).
    El criterio de valoración principal de la eficacia es el porcentaje de pacientes en remisión en la visita de la semana 12. La remisión se define, según la puntuación compuesta de los síntomas percibidos por el paciente mediante el diario electrónico y la evaluación centralizada de la endoscopia, del modo siguiente:
    • Subpuntuación de la frecuencia de las deposiciones de 0 o 1 con una variación de al menos 1 punto con respecto al valor basal.
    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 12 visit
    Visita de la semana 12
    E.5.2Secondary end point(s)
    • Proportion of subjects with endoscopic remission, as defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability), at the Week 12 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 baseline in stool frequency subscore, and rectal bleeding subscore of 0, at the Week 12 visit.
    • Proportion of subjects with clinical response based on composite score at the Week 12 visit. Clinical response (composite) is defined as a decrease from 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.
    • Proportion of subjects with mucosal healing based on endoscopic and histological assessment at the Week 12 visit. Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of ≤2.
    • Porcentaje de sujetos con remisión endoscópica, definida por una subpuntuación de 0 o 1 en la evaluación centralizada de la endoscopia (modificada, se excluye la friabilidad), en la visita de la semana 12.
    • Porcentaje de sujetos con remisión clínica, definida por una subpuntuación de frecuencia de las deposiciones de 0 a 1 con una variación de al menos 1 punto con respecto al valor basal y una subpuntuación de rectorragia de 0, en la visita de la semana 12.
    • Porcentaje de sujetos con respuesta clínica según la puntuación compuesta en la visita de la semana 12. La respuesta clínica (compuesta) se define como una disminución de la puntuación compuesta de los síntomas percibidos por el paciente mediante el diario electrónico y la evaluación centralizada de la endoscopia de al menos 2 puntos y al menos el 30% con respecto al momento basal, acompañada de una disminución de la subpuntuación de la rectorragia de al menos 1 punto o una subpuntuación de la rectorragia ≤ 1.
    • Porcentaje de sujetos con cicatrización de la mucosa según la evaluación endoscópica e histológica en la visita de la semana 12. La cicatrización de la mucosa se define por una puntuación de 0 o 1 en la evaluación centralizada de la endoscopia (modificada, se excluye la friabilidad) y una puntuación ≤ 2 en la escala de Geboes determinada centralmente.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 visit
    Visita de la semana 12
    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 or 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 EEA53
    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
    Belgium
    Bosnia and Herzegovina
    Bulgaria
    Canada
    Colombia
    France
    Greece
    Hungary
    Ireland
    Japan
    Korea, Republic of
    Mexico
    Portugal
    Slovakia
    Spain
    Switzerland
    Ukraine
    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 ultimo sujeto, en todos los centros, completa su evaluación final definida por el protocolo. Teniendo en cuenta que esto 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 years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days19
    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: 82
    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: 82
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 726
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 253
    F.4.2.2In the whole clinical trial 825
    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 12 week treatment period, eligible subjects will be offered the opportunity to participate in a double-blind maintenance study (SHP647-303; for subjects who achieve clinical response) or a long-term safety extension (LTS) study (SHP647-304; for subjects who do not achieve a clinical response). At the end of SHP647 study participation, patients will return to standard of care.
    Al final del período de tratamiento de 12 semanas, se les ofrecerá a los sujetos elegibles la oportunidad de participar en un estudio de mantenimiento doble ciego (SHP647-303, para sujetos que logran respuesta clínica) o un estudio de extensión de seguridad a largo plazo (LTS) ( SHP647-304; para sujetos que no logran una respuesta clínica). Al final de la participación en el estudio SHP647, los pacientes volverán a la atención estándar.
    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 trial2020-10-06
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