Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease
21 de fevereiro de 2016 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
- 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 estudo
Intervencional
Inscrição (Real)
175
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Berlin, Alemanha
- DRK Clinics Berlin Westend
-
Frankfurt-am-Main, Alemanha
- Interdisciplinary Crohn Colitis Center Rhein Main
-
Hamburg, Alemanha
- Asklepios West Hospital Hamburg
-
Jena, Alemanha
- University Hospital Jena
-
Kiel, Alemanha
- University Hospital Schleswig-Holstein
-
Magdeburg, Alemanha
- University Hospital Magdeburg
-
Minden, Alemanha
- Gastroenterology Group Practice Minden
-
Oldenburg, Alemanha
- Internal Medicine Group Practice Oldenburg
-
-
-
-
-
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
-
-
-
-
-
Barnaul, Federação Russa
- Territorial Clinical Hospital
-
Kazan, Federação Russa
- State Medical University
-
Krasnoyarsk, Federação Russa
- Territorial Clinical Hospital
-
Moscow, Federação Russa
- City Clinical Hospital #24
-
Moscow, Federação Russa
- A.N. Ryzhikh State Research Center for Coloproctology
-
Moscow, Federação Russa
- Moscow Clinical Research Center
-
Moscow, Federação Russa
- Vladimirsky Regional Clinical Research Institute
-
Nizhny Novgorod, Federação Russa
- Semashko Nizhny Novgorod Regional Clinical Hospital
-
Novosibirsk, Federação Russa
- City Clinical Hospital #12
-
Saint Petersburg, Federação Russa
- City Clinical Hospital #31
-
Saint Petersburg, Federação Russa
- First Pavlov State Medical University
-
Saint Petersburg, Federação Russa
- Mechnikov North-Western State Medical University
-
Saint Petersburg, Federação Russa
- St. Elizabeth City Hospital
-
-
-
-
-
Clermont-Ferrand, França
- Hospital Gabriel Montpied
-
Clichy, França
- Beaujon Hospital
-
Dijon, França
- Dijon University Hospital Center
-
Grenoble, França
- Hospital Michallon
-
Lille, França
- Lille Regional University Hospital Center
-
Marseille, França
- North Hospital
-
Nice, França
- Archet Hospital
-
Saint Etienne, França
- Saint Etienne University Hospital Center
-
-
-
-
-
Balatonfured, Hungria
- Drug Research Center Ltd.
-
Budapest, Hungria
- Semmelweis University
-
Budapest, Hungria
- ClinExpert Medical Center
-
Budapest, Hungria
- Szent Margit Hospital
-
Debrecen, Hungria
- University of Debrecen, Medical and Health Science Center
-
Gyula, Hungria
- Bekes County Pandy Kalman Hospital
-
Szekszard, Hungria
- Tolna County Balassa Janos Hospital
-
-
-
-
-
Bydgoszcz, Polônia
- Jan Biziel University Hospital #2
-
Lodz, Polônia
- Saint Family Hospital Medical Center
-
Tychy, Polônia
- H-T. Medical Center
-
Warsaw, Polônia
- Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
-
Warsaw, Polônia
- Vivamed
-
Warsaw, Polônia
- Clinical Hospital of Ministry of Internal Affairs and Administration
-
Wroclaw, Polônia
- Active Health Center
-
-
-
-
-
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
-
-
-
-
-
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
-
-
-
-
-
Bucharest, Romênia
- Colentina Clinical Hospital
-
Bucharest, Romênia
- Fundeni Clinical Institute
-
Cluj-Napoca, Romênia
- Medical Center for Gastroenterology
-
Timisoara, Romênia
- Center for Gastroenterology, Ltd
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: GLPG0634 200 mg QD
2 tablets of 100 mg GLPG0634 in the morning
|
100 mg oral tablet, intake once daily for 20 weeks
Outros nomes:
|
|
Experimental: GLPG0634 100 mg QD
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
|
100 mg oral tablet, intake once daily for 20 weeks
Outros nomes:
placebo oral tablets, intake once daily for 20 weeks
Outros nomes:
|
|
Comparador de Placebo: Placebo QD
2 placebo tablets in the morning
|
placebo oral tablets, intake once daily for 20 weeks
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of subjects achieving clinical remission at Week 10
Prazo: Week 10
|
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
|
Week 10
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of subjects achieving clinical remission
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Pille Harrison, MD, Galapagos NV
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de fevereiro de 2014
Conclusão Primária (Real)
1 de novembro de 2015
Conclusão do estudo (Real)
1 de fevereiro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
27 de janeiro de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de janeiro de 2014
Primeira postagem (Estimativa)
29 de janeiro de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
23 de fevereiro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de fevereiro de 2016
Última verificação
1 de fevereiro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GLPG0634-CL-211
- 2013-002857-32 (Número EudraCT)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .