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    Summary
    EudraCT Number:2010-022384-35
    Sponsor's Protocol Code Number:CCX114644
    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:2012-01-11
    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 number2010-022384-35
    A.3Full title of the trial
    An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn's Disease
    Estudio abierto de extensión para evaluar la seguridad de GSK1605786A en pacientes con Enfermedad de Crohn
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn's disease
    Un estudio de 25 meses de una nueva posible medicina (GSK1605786A) para el tratamiento de la enfermedad de Crohn.
    A.3.2Name or abbreviated title of the trial where available
    Open label extension study
    Estudio de extensión abierto
    A.4.1Sponsor's protocol code numberCCX114644
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClincial Trials HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+440208990 44 66
    B.5.5Fax number+440208990 12 34
    B.5.6E-mailGSKClincialSupportHD@gsk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGSK1605786A
    D.3.2Product code GSK1605786A
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeGSK1605786A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with Crohn's Disease
    Sujetos con enfermedad de Crohn.
    E.1.1.1Medical condition in easily understood language
    Crohn's disease Inflammatory bowel disease
    Enfermedad de Crohn, enfermedad inflamatoria intestinal.
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of long-term treatment with GSK1605786A in
    subjects with Crohn's disease.
    Evaluar la seguridad y la tolerabilidad del tratamiento a largo plazo con GSK1605786A en sujetos con enfermedad de Crohn.
    E.2.2Secondary objectives of the trial
    - To assess the effectiveness of long-term treatment with GSK1605786A
    - To assess changes in health-related quality of life
    - To assess changes in healthcare-related resource utilisation
    - To assess changes in work productivity and activity impairment
    - To assess changes in unemployment and disability rates
    - To assess changes in C-reactive protein (CRP) as a biomarker of
    inflammation
    - To potentially evaluate the correlation of genetic markers with the safety and effectiveness of GSK1605786A.
    - Evaluar la eficacia del tratamiento a largo plazo con GSK1605786A
    - Evaluar las variaciones de la calidad de vida relacionada con la salud
    - Evaluar las variaciones de la utilización de recursos sanitarios
    - Evaluar las variaciones del deterioro de la productividad laboral y la actividad
    - Evaluar las variaciones de las tasas de desempleo y discapacidad
    - Evaluar las variaciones de la proteína C reactiva (PCR) como marcador de la inflamación
    - Evaluar posiblemente la correlación de los marcadores genéticos con la seguridad y la eficacia de GSK1605786A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Previous participation in a GSK-sponsored study with GSK1605786A as follows:
    a. completion of the placebo-controlled induction study, CCX114151, without achieving clinical response (CDAI => 100 point decrease) or clinical remission (CDAI < 150) at Week 12 or completion of other GSK-sponsored induction studies, with the exception of Study CCX114643, as designated by the sponsor
    b. completion of maintenance study CCX114157 at Week 52
    c. withdrawal from maintenance study CCX114157 due to worsening of Crohn's disease and requiring a treatment change
    2. Written informed consent prior to any CCX114644-specific study procedures
    3. Females of child-bearing potential (FCBP) must be sexually inactive or commit to use of contraceptive methods with a failure rate of < 1% per year when used consistently and correctly and, when applicable, in accordance with the product label, for the duration of this study as defined by the following: Contraceptive Methods with a Failure Rate of < 1%
    - Abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle
    - Oral contraceptive, either combined or progestogen alone
    - Injectable progestogen
    - Implants of etonogestrel or levonorgestrel
    - Estrogenic vaginal ring
    - Percutaneous contraceptive patches
    - Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label
    - Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject. The information on the male sterility can come from the site personnel's: review of subject's medical records; medical examination of the subject and/or semen analysis; or interview with the subject on his medical history.
    - Male condom combined with a vaginal spermicide (foam, gel, film,
    cream, or suppository)
    - Male condom combined with a female diaphragm, either with or
    without a vaginal spermicide (foam, gel, film, cream, or suppository)
    These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring subjects understand how to properly use these methods of contraception. This list does not apply to FCBP with same sex partners, when this is their preferred and usual lifestyle.
    1. Participación previa en un estudio de GSK1605786A patrocinado por GSK:
    a. finalización del estudio de inducción controlado con placebo, CCX114151, sin haber logrado ni una respuesta clínica (descenso del CDAI >=100 puntos) ni una remisión clínica (CDAI <150) en la semana 12 o finalización de otros estudios de inducción patrocinados por GSK, con la excepción del estudio CCX114643, que designe el promotor
    b. finalización del estudio de mantenimiento CCX114157 en la semana 52
    c. retirada del estudio de mantenimiento CCX114157 debido a un empeoramiento de la enfermedad de Crohn y necesidad de un cambio de tratamiento.
    2. Consentimiento informado por escrito antes de realizar ningún procedimiento específico del estudio CCX114644.
    3. Las mujeres en edad fértil (MEF) deben permanecer sexualmente inactivas o comprometerse a utilizar métodos anticonceptivos con una tasa de fracasos <1 % anual cuando se utilizan de forma sistemática y correcta y, en su caso, de acuerdo con la ficha técnica del producto, durante todo este estudio según se define a continuación:
    Métodos anticonceptivos con una tasa de fracasos <1 %
    - Abstinencia de relaciones sexuales con penetración vaginal, cuando sea el hábito preferido y habitual de la mujer.
    - Anticonceptivos orales, ya sea combinados o con progesterona sola.
    - Progestágeno inyectable
    - Implantes de etonogestrel o levonorgestrel
    - Anillo vaginal estrogénico
    - Parches anticonceptivos percutáneos
    - Dispositivo intrauterino (DIU) o sistema intrauterino (SIU) que cumpla la tasa de fracasos <1 % según se describe en la ficha técnica
    - Esterilización de la pareja masculina antes de la incorporación de la mujer al estudio, cuando el varón sea la única pareja de la paciente. La información sobre la esterilidad masculina puede proceder del personal del centro: revisión de las historias clínicas del sujeto, exploración física del sujeto o espermiograma o entrevista con el sujeto sobre su historia clínica.
    - Preservativo masculino combinado con espermicida vaginal (espuma, gel, película, crema o supositorio)
    - Preservativo masculino combinado con un diafragma femenino, con o sin espermicida vaginal (espuma, gel, película, crema o supositorio)
    Estos métodos anticonceptivos permitidos solo son eficaces cuando se utilizan de manera sistemática, correcta y de conformidad con la ficha técnica del producto. El investigador es responsable de garantizar que los sujetos conozcan el modo de empleo correcto de estos métodos anticonceptivos. Esta lista no se aplica a las MEF con parejas del mismo sexo, cuando éste sea su hábito preferido y habitual.
    E.4Principal exclusion criteria
    1. If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is
    planning to become pregnant
    2. Subjects with known or suspected coeliac disease or a positive screening test for antitissue transglutaminase (anti-tTG) antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tTG antibodies and excluded or withdrawn from study upon positive test result.
    3. Fixed symptomatic stenoses of small bowel or colon
    4. Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
    5. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks
    6. Use of prohibited medications at baseline and throughout the study (Section 5.4.2 of the protocol - Prohibited Medications and Non Drug Therapies)
    7. The subject exhibits evidence of hepatic dysfunction or viral hepatitis; has serum ALT (SGPT) and/or AST (SGOT) values >= 2 times the upper limit of normal, a total bilirubin value >1.5 times the upper limit of normal (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%), or alkaline phosphatase >1.5 times the upper limit of normal; has current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH); or has known hepatic or biliary abnormalities with the exception of Gilbert?s syndrome or asymptomatic gallstones.
    8. Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the Investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.
    1. En el caso de las mujeres, la paciente está embarazada, da positivo en una prueba de embarazo o está en período de lactancia, o tiene intención de quedarse embarazada.
    2. Los sujetos con enfermedad celíaca conocida o sospechada o con una prueba de cribado positiva de anticuerpos antitransglutaminasa tisular (anti-TGt) tendrán que haber sido excluidos de participar en cualquier estudio de inducción. Cuando se sospeche posteriormente un diagnóstico de enfermedad celíaca, se analizará la presencia de anticuerpos anti-TGt y se excluirá o retirará al sujeto del estudio si el resultado es positivo.
    3. Estenosis sintomáticas fijas del intestino delgado o el colon.
    4. Fístulas enterocutáneas, abdominales o pélvicas con probabilidad de precisar una intervención quirúrgica durante el período del estudio.
    5. Sepsis o infecciones presentes con necesidad de tratamiento antibiótico por vía intravenosa durante >2 semanas.
    6. Uso de medicamentos prohibidos en el momento basal y durante todo el estudio (sección 5.4.2 Medicamentos y tratamientos no farmacológicos prohibidos)
    7. El sujeto presenta datos de disfunción hepática, hepatitis viral o valores séricos de ALT (SGPT) o AST (SGOT) >= 2 veces el límite superior de la normalidad, un valor de bilirrubina total >1,5 veces el límite superior de la normalidad (se acepta un valor aislado de bilirrubina >1,5 veces el límite superior de la normalidad si la bilirrubina es fraccionada y la bilirrubina directa es <35 %), un valor de fosfatasa alcalina > 1,5 veces el límite superior de la normalidad, antecedentes de hepatopatía activa o crónica, incluida esteatohepatitis no alcohólica (EHNA), o anomalías hepáticas o biliares conocidas, a excepción de síndrome de Gilbert o colelitiasis asintomática.
    8. Sujetos que manifestaran problemas de seguridad o tolerabilidad durante su participación en un estudio previo de GSK1605786A que, en opinión del investigador, estuvieran posiblemente relacionados con el tratamiento del estudio y supongan un riesgo inaceptable para el sujeto.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Primary Endpoints:

    Incidence of adverse events/Serious adverse events
    Criterio de valoración principal de seguridad:

    Incidencia de acontecimientos adversos y de acontecimientos adversos graves.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety assessments at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and post 4 week follow-up at Week 112.
    12 lead ECG at Week 0, 24, 48, 72, 108 and post 4 week follow-up at Week 112.
    CDAI assessments at Week 0, 12, 24, 36, 48, 60, 72, 84, 96 108 and post 4 week follow-up at Week 112.
    Valoración de seguridad en la semana 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 y después del seguimiento de 4 semanas en la Semana 112.
    ECG de 12 derivaciones en la Semana 0, 24, 48, 72, 108 y después del seguimiento de 4 semanas en la Semana 112. Valoraciones del CDAI en la Semana 0, 12, 24, 36, 48, 60, 72, 84, 96, 108 y después del seguimiento de 4 semanas en la Semana 112.
    E.5.2Secondary end point(s)
    - Change from baseline in vital signs: heart rate and blood pressure.
    - Change from baseline in haematology and clinical chemistry parameters.
    - Change from baseline in liver function test parameters.
    - Change from baseline in 12 lead ECG abnormalities.
    - Variación con respecto al momento basal de las constantes vitales: frecuencia cardíaca y presión arterial
    - Variación con respecto al momento basal de los parámetros de hematología y bioquímica clínica.
    - Variación con respecto al momento basal de los parámetros de las pruebas funcionales hepáticas.
    - Variación con respecto al momento basal de las anomalías en el ECG de 12 derivaciones.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety assessments at Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and post 4 week follow-up at Week 112.
    12 lead ECG at Week 0, 24, 48, 72, 108 and post 4 week follow-up at Week 112.
    CDAI assessments at Week 0, 12, 24, 36, 48, 60, 72, 84, 96 108 and post 4 week follow-up at Week 112.
    Valoración de seguridad en la semana 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 y después del seguimiento de 4 semanas, en la Semana 112.
    12 derivaciones del ECG en la Semana 0, 24, 48, 72, 108 y después del seguimiento de 4 semanas, en la Semana 112. Valoraciones del CDAI en la Semana 0, 12, 24, 36, 48, 60, 72, 84, 96, 108 y después del seguimiento de 4 semanas, en la Semana 112.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA158
    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
    Brazil
    Canada
    China
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Russian Federation
    Spain
    Sweden
    Switzerland
    Taiwan
    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
    Last Subject Last Visit
    Última visita del último paciente.
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 766
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 800
    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)
    The investigator is responsible for the post-study care of the patient's medical condition.

    The study will be conducted for 108 weeks. The risk-to-benefit ratio will be re-assessed when the results of induction study CCX114151 are available and at periodic intervals thereafter. If appropriate, the duration of the open-label study may be amended.
    El investigador es responsable del cuidado posterior al estudio de la enfermedad del paciente.

    El estudio se llevará a cabo durante 108 semanas. Se volverá a evaluar la relación riesgo-beneficio cuando los resultados del estudio de inducción CCX114151 estén disponibles y en intervalos periódicos de ahí en adelante. Si procede, la duración del estudio abierto puede modificarse.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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