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

21 febbraio 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

  • 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 di studio

Interventistico

Iscrizione (Effettivo)

175

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
      • Brussels, Belgio
        • St. Pierre University Hospital Center
      • Brussels, Belgio
        • University Hospital Saint Luc
      • Ghent, Belgio
        • University Hospital Ghent
      • Leuven, Belgio
        • University Hospitals Leuven
      • Liege, Belgio
        • CHR de la Citadelle
      • Liege, Belgio
        • Clinic Saint Joseph
  • Federazione Russa
      • Barnaul, Federazione Russa
        • Territorial Clinical Hospital
      • Kazan, Federazione Russa
        • State Medical University
      • Krasnoyarsk, Federazione Russa
        • Territorial Clinical Hospital
      • Moscow, Federazione Russa
        • City Clinical Hospital #24
      • Moscow, Federazione Russa
        • A.N. Ryzhikh State Research Center for Coloproctology
      • Moscow, Federazione Russa
        • Moscow Clinical Research Center
      • Moscow, Federazione Russa
        • Vladimirsky Regional Clinical Research Institute
      • Nizhny Novgorod, Federazione Russa
        • Semashko Nizhny Novgorod Regional Clinical Hospital
      • Novosibirsk, Federazione Russa
        • City Clinical Hospital #12
      • Saint Petersburg, Federazione Russa
        • City Clinical Hospital #31
      • Saint Petersburg, Federazione Russa
        • First Pavlov State Medical University
      • Saint Petersburg, Federazione Russa
        • Mechnikov North-Western State Medical University
      • Saint Petersburg, Federazione Russa
        • 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
  • Germania
      • Berlin, Germania
        • DRK Clinics Berlin Westend
      • Frankfurt-am-Main, Germania
        • Interdisciplinary Crohn Colitis Center Rhein Main
      • Hamburg, Germania
        • Asklepios West Hospital Hamburg
      • Jena, Germania
        • University Hospital Jena
      • Kiel, Germania
        • University Hospital Schleswig-Holstein
      • Magdeburg, Germania
        • University Hospital Magdeburg
      • Minden, Germania
        • Gastroenterology Group Practice Minden
      • Oldenburg, Germania
        • Internal Medicine Group Practice Oldenburg
  • 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
  • Regno Unito
      • Birmingham, Regno Unito
        • Queen Elizabeth Hospital
      • Bournemouth, Regno Unito
        • Royal Bournemouth Hospital
      • Harrow, Regno Unito
        • St Mark's Hospital
      • Manchester, Regno Unito
        • Manchester Royal Infirmary
  • Repubblica Ceca
      • Hradec Kralove, Repubblica Ceca
        • Hepato-Gastroenterology HK Ltd.
      • Olomouc, Repubblica Ceca
        • University Hospital Olomouc
      • Pilsen, Repubblica Ceca
        • Outpatient Clinic of Internal Medicine and Gastroenterology
      • Prague, Repubblica Ceca
        • Institute of clinical and experimental medicine
      • Usti nad Labem, Repubblica Ceca
        • Masaryk's Hospital Usti Nad Labem
      • Znojmo, Repubblica Ceca
        • Hospital Znojmo
  • Romania
      • Bucharest, Romania
        • Colentina Clinical Hospital
      • Bucharest, Romania
        • Fundeni Clinical Institute
      • Cluj-Napoca, Romania
        • Medical Center for Gastroenterology
      • Timisoara, Romania
        • Center for Gastroenterology, Ltd
  • Ungheria
      • Balatonfured, Ungheria
        • Drug Research Center Ltd.
      • Budapest, Ungheria
        • Semmelweis University
      • Budapest, Ungheria
        • ClinExpert Medical Center
      • Budapest, Ungheria
        • Szent Margit Hospital
      • Debrecen, Ungheria
        • University of Debrecen, Medical and Health Science Center
      • Gyula, Ungheria
        • Bekes County Pandy Kalman Hospital
      • Szekszard, Ungheria
        • Tolna County Balassa Janos Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Altri nomi:
  • Compresse GLPG0634
Sperimentale: 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
Altri nomi:
  • Compresse GLPG0634
Droga: Placebo
placebo oral tablets, intake once daily for 20 weeks
Altri nomi:
  • Compresse di placebo
Comparatore placebo: Placebo QD
2 placebo tablets in the morning
Droga: Placebo
placebo oral tablets, intake once daily for 20 weeks
Altri nomi:
  • Compresse di placebo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of subjects achieving clinical remission at Week 10
Lasso di tempo: Week 10
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
Week 10

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of subjects achieving clinical remission
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Galapagos NV

Investigatori

  • Direttore dello studio: Pille Harrison, MD, Galapagos NV

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2014

Completamento primario (Effettivo)

1 novembre 2015

Completamento dello studio (Effettivo)

1 febbraio 2016

Date di iscrizione allo studio

Primo inviato

27 gennaio 2014

Primo inviato che soddisfa i criteri di controllo qualità

27 gennaio 2014

Primo Inserito (Stima)

29 gennaio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

23 febbraio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 febbraio 2016

Ultimo verificato

1 febbraio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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