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Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease

21 de febrero de 2016 actualizado por: Galapagos NV

Double-Blind, Randomized, Placebo-Controlled, Multi-Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease With Evidence of Mucosal Ulceration

  • 180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or matching placebo once daily for 20 weeks in addition to their stable background treatment.
  • During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects GLPG0634 administration on subjects' quality of life will be evaluated.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

  • 180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated when taking GLPG0634 or matching placebo once daily in addition to their stable background treatment. The population will include 50% anti-TNF naïve patients and 50% of subjects previously exposed to anti-TNF.
  • The study will consist of 2 parts, with total treatment duration of 20 weeks. Randomisation in Part 1 will be stratified according to subject's previous anti-TNF exposure, C-reactive protein (CRP) level at Screening and oral corticosteroid use at Day -1. However, at Week 10, subjects will be re-randomized automatically and stratified according to the subject's clinical response (reduction of Crohn's Disease Activity Index (CDAI) of 100 points), previous anti-TNF exposure and corticosteroid use at Day -1 to receive GLPG0634 200 mg q.d., 100 mg q.d. doses, or matching placebo q.d. in a blinded fashion. In Part 2, all will continue the study until Week 20.
  • As efficacy parameters, the ability to achieve clinical response or remission, endoscopic response & remission as well as mucosal healing with GLPG0634 given once daily compared to placebo will be evaluated after 10 weeks of treatment. In subjects who achieved clinical remission at Week 10, maintenance of the remission will be assessed during Part 2 of the study.
  • During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects of different doses and dose regimens of GLPG0634 administration on subjects' quality of life will be evaluated.

Tipo de estudio

Intervencionista

Inscripción (Actual)

175

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania
        • DRK Clinics Berlin Westend
      • Frankfurt-am-Main, Alemania
        • Interdisciplinary Crohn Colitis Center Rhein Main
      • Hamburg, Alemania
        • Asklepios West Hospital Hamburg
      • Jena, Alemania
        • University Hospital Jena
      • Kiel, Alemania
        • University Hospital Schleswig-Holstein
      • Magdeburg, Alemania
        • University Hospital Magdeburg
      • Minden, Alemania
        • Gastroenterology Group Practice Minden
      • Oldenburg, Alemania
        • Internal Medicine Group Practice Oldenburg
  • Bélgica
      • Brussels, Bélgica
        • St. Pierre University Hospital Center
      • Brussels, Bélgica
        • University Hospital Saint Luc
      • Ghent, Bélgica
        • University Hospital Ghent
      • Leuven, Bélgica
        • University Hospitals Leuven
      • Liege, Bélgica
        • CHR de la Citadelle
      • Liege, Bélgica
        • Clinic Saint Joseph
  • Federación Rusa
      • Barnaul, Federación Rusa
        • Territorial Clinical Hospital
      • Kazan, Federación Rusa
        • State Medical University
      • Krasnoyarsk, Federación Rusa
        • Territorial Clinical Hospital
      • Moscow, Federación Rusa
        • City Clinical Hospital #24
      • Moscow, Federación Rusa
        • A.N. Ryzhikh State Research Center for Coloproctology
      • Moscow, Federación Rusa
        • Moscow Clinical Research Center
      • Moscow, Federación Rusa
        • Vladimirsky Regional Clinical Research Institute
      • Nizhny Novgorod, Federación Rusa
        • Semashko Nizhny Novgorod Regional Clinical Hospital
      • Novosibirsk, Federación Rusa
        • City Clinical Hospital #12
      • Saint Petersburg, Federación Rusa
        • City Clinical Hospital #31
      • Saint Petersburg, Federación Rusa
        • First Pavlov State Medical University
      • Saint Petersburg, Federación Rusa
        • Mechnikov North-Western State Medical University
      • Saint Petersburg, Federación Rusa
        • St. Elizabeth City Hospital
  • Francia
      • Clermont-Ferrand, Francia
        • Hospital Gabriel Montpied
      • Clichy, Francia
        • Beaujon Hospital
      • Dijon, Francia
        • Dijon University Hospital Center
      • Grenoble, Francia
        • Hospital Michallon
      • Lille, Francia
        • Lille Regional University Hospital Center
      • Marseille, Francia
        • North Hospital
      • Nice, Francia
        • Archet Hospital
      • Saint Etienne, Francia
        • Saint Etienne University Hospital Center
  • Hungría
      • Balatonfured, Hungría
        • Drug Research Center Ltd.
      • Budapest, Hungría
        • Semmelweis University
      • Budapest, Hungría
        • ClinExpert Medical Center
      • Budapest, Hungría
        • Szent Margit Hospital
      • Debrecen, Hungría
        • University of Debrecen, Medical and Health Science Center
      • Gyula, Hungría
        • Bekes County Pandy Kalman Hospital
      • Szekszard, Hungría
        • Tolna County Balassa János Hospital
  • Polonia
      • Bydgoszcz, Polonia
        • Jan Biziel University Hospital #2
      • Lodz, Polonia
        • Saint Family Hospital Medical Center
      • Tychy, Polonia
        • H-T. Medical Center
      • Warsaw, Polonia
        • Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
      • Warsaw, Polonia
        • Vivamed
      • Warsaw, Polonia
        • Clinical Hospital of Ministry of Internal Affairs and Administration
      • Wroclaw, Polonia
        • Active Health Center
  • Reino Unido
      • Birmingham, Reino Unido
        • Queen Elizabeth Hospital
      • Bournemouth, Reino Unido
        • Royal Bournemouth Hospital
      • Harrow, Reino Unido
        • St Mark's Hospital
      • Manchester, Reino Unido
        • Manchester Royal Infirmary
  • República Checa
      • Hradec Kralove, República Checa
        • Hepato-Gastroenterology HK Ltd.
      • Olomouc, República Checa
        • University Hospital Olomouc
      • Pilsen, República Checa
        • Outpatient Clinic of Internal Medicine and Gastroenterology
      • Prague, República Checa
        • Institute of Clinical and Experimental Medicine
      • Usti nad Labem, República Checa
        • Masaryk's Hospital Usti Nad Labem
      • Znojmo, República Checa
        • Hospital Znojmo
  • Rumania
      • Bucharest, Rumania
        • Colentina Clinical Hospital
      • Bucharest, Rumania
        • Fundeni Clinical Institute
      • Cluj-Napoca, Rumania
        • Medical Center for Gastroenterology
      • Timisoara, Rumania
        • Center for Gastroenterology, Ltd

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Male or female subjects between 18 and 75 years
  • Documented history of ileal, colonic, or ileocolonic CD
  • CDAI score ≥ 220 to ≤ 450
  • Evidence of active inflammation as demonstrated by endoscopic confirmation of active disease
  • Subjects previously not exposed to anti-TNF treatment (TNF-naïve) or subjects previously exposed to anti-TNF therapy at a registered dose, that has been discontinued at least 8 weeks prior to Screening and deemed by the treating physician as a primary or secondary non-responder or intolerant (TNF-experienced)
  • Continuation of concurrent treatment with oral steroids (≤30 mg prednisolone eq/day), mesalazine, olsalazine, CD-related antibiotics and probiotics at stable dose is allowed
  • Previous exposure to immunomodulators is permitted, but must be discontinued
  • Haematology and biochemistry lab parameters within predefined ranges as stated in the protocol

Exclusion Criteria:

  • Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC
  • Stoma, gastric or ileoanal pouch, procto- or total colectomy, symptomatic stenosis or obstructive strictures, history of bowel perforation, (suspected) abscess; actively draining fistulae
  • Subject who has had surgical bowel resections within the past 6 months, short bowel syndrome or is receiving tube feeding, defined formula diets, or parenteral alimentation
  • Subject with positive Clostridium difficile toxin stool assay or evidence of any other gastrointestinal infection
  • Subject who has received non-permitted IBD therapies within specified timeframes, depending on the medication, as stated in the protocol
  • Subject with a (previous history of) dysplasia of the gastrointestinal tract
  • Concurrent gastro-intestinal malignancy or a history of cancer elsewhere
  • History of lymphoproliferative disease
  • Known active infection of any kind, current therapy for chronic infection or history of specific infections as stated in the protocol
  • Subject who is pregnant, lactating or not willing to maintain highly effective birth control methods during the course of the study and 12 weeks thereafter

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: GLPG0634 200 mg QD
2 tablets of 100 mg GLPG0634 in the morning
Droga: GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
Otros nombres:
  • GLPG0634 tabletas
Experimental: GLPG0634 100 mg QD
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
Droga: GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
Otros nombres:
  • GLPG0634 tabletas
Droga: Placebo
placebo oral tablets, intake once daily for 20 weeks
Otros nombres:
  • Tabletas de placebo
Comparador de placebos: Placebo QD
2 placebo tablets in the morning
Droga: Placebo
placebo oral tablets, intake once daily for 20 weeks
Otros nombres:
  • Tabletas de placebo

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of subjects achieving clinical remission at Week 10
Periodo de tiempo: Week 10
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
Week 10

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of subjects achieving clinical remission
Periodo de tiempo: Up to Week 20
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points, assessed at every visit
Up to Week 20
Percentage of subjects achieving clinical response
Periodo de tiempo: Up to Week 20
Percentage of subjects achieving clinical response as defined by a decrease in Crohn's Disease Activity Index score of at least 100 points, assessed at every visit
Up to Week 20
Percentage of subjects achieving endoscopic remission at Week 10
Periodo de tiempo: Week 10
Percentage of subjects achieving endoscopic remission as defined by a reduction of Simplified Endoscopy Score for Crohn's Disease (SES-CD) score ≤ 4, with ulcerated surface subscore no greater than 1 in any segment at Week 10
Week 10
Percentage of subjects achieving endoscopic response at Week 10
Periodo de tiempo: Week 10
Percentage of subjects achieving endoscopic response as defined by a reduction of Simplified Endoscopy Score for Crohn's Disease (SES-CD) score by at least 50% from Screening at Week 10
Week 10
Percentage of subjects achieving mucosal healing at Week 10
Periodo de tiempo: Week 10
Percentage of subjects achieving mucosal healing as defined by a Simplified Endoscopy Score for Crohn's Disease (SES-CD) score equal to 0 at Week 10
Week 10
Change from Baseline in Crohn's Disease Activity Index score
Periodo de tiempo: Up to Week 20
Change from Baseline in Crohn's Disease Activity Index score, assessed at every visit
Up to Week 20
Change from Screening in endoscopic score
Periodo de tiempo: Week 10
Change from Screening in endoscopic Simplified Endoscopy Score for Crohn's Disease (SES-CD) score at Week 10
Week 10
Change from Screening in histopathology biopsy score
Periodo de tiempo: Week 10
Change from Screening in histopathology biopsy score at Week 10
Week 10
Change from Baseline in Subjects' Quality of Life (based on the Inflammatory Bowel Disease Questionnaire (IBDQ) questionnaire score)
Periodo de tiempo: Up to Week 20
Change from Baseline in Subjects' Quality of Life based on the IBDQ questionnaire score at Week 10 and Week 20
Up to Week 20
The number of subjects with adverse events
Periodo de tiempo: From screening up to 2 weeks after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs)
From screening up to 2 weeks after last dose
The number of subjects with abnormal lab tests
Periodo de tiempo: From screening up to 2 weeks after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms laboratory test abnormalities
From screening up to 2 weeks after last dose
The number of subjects with abnormal vital signs
Periodo de tiempo: From screening up to 2 weeks after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in vital signs
From screening up to 2 weeks after last dose
The number of subjects with abnormal ECG
Periodo de tiempo: From screening up to 2 weeks after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in electrocardiogram (ECG)
From screening up to 2 weeks after last dose
The plasma levels of GLPG0634 and its metabolite
Periodo de tiempo: Up to Week 20
To characterize the pharmacokinetics (PK) of GLPG0634 and its metabolite by measuring the amount in plasma from Week 2 up to Week 20 at every visit
Up to Week 20
The change versus Baseline in levels of immune- and inflammation-related parameters in whole blood and serum
Periodo de tiempo: Up to Week 20
To characterize the pharmacodynamics (PD) of GLPG0634 and its metabolite by measuring the levels of immune- and inflammation-related parameters in whole blood and serum
Up to Week 20
The change versus Baseline in levels of faecal calprotectin
Periodo de tiempo: Up to Week 20
To characterize the pharmacodynamics (PD) of GLPG0634 and its metabolite by measuring the levels of faecal calprotectin
Up to Week 20
The change versus Baseline in microbial communities in stool samples
Periodo de tiempo: Up to Week 10
To characterize the effects of GLPG0634 and its metabolite on the microbial communities by measuring the levels of predominant microbiota in stool samples
Up to Week 10

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Galapagos NV

Investigadores

  • Director de estudio: Pille Harrison, MD, Galapagos NV

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de febrero de 2014

Finalización primaria (Actual)

1 de noviembre de 2015

Finalización del estudio (Actual)

1 de febrero de 2016

Fechas de registro del estudio

Enviado por primera vez

27 de enero de 2014

Primero enviado que cumplió con los criterios de control de calidad

27 de enero de 2014

Publicado por primera vez (Estimar)

29 de enero de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

23 de febrero de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

21 de febrero de 2016

Última verificación

1 de febrero de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GLPG0634-CL-211
  • 2013-002857-32 (Número EudraCT)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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