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

21. února 2016 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

  • 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.

Typ studie

Intervenční

Zápis (Aktuální)

175

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: GLPG0634 200 mg QD
2 tablets of 100 mg GLPG0634 in the morning
Lék: GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
Ostatní jména:
  • Tablety GLPG0634
Experimentální: GLPG0634 100 mg QD
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
Lék: GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
Ostatní jména:
  • Tablety GLPG0634
Lék: Placebo
placebo oral tablets, intake once daily for 20 weeks
Ostatní jména:
  • Placebo tablety
Komparátor placeba: Placebo QD
2 placebo tablets in the morning
Lék: Placebo
placebo oral tablets, intake once daily for 20 weeks
Ostatní jména:
  • Placebo tablety

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of subjects achieving clinical remission at Week 10
Časové okno: Week 10
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
Week 10

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of subjects achieving clinical remission
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Galapagos NV

Vyšetřovatelé

  • Ředitel studie: Pille Harrison, MD, Galapagos NV

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. února 2014

Primární dokončení (Aktuální)

1. listopadu 2015

Dokončení studie (Aktuální)

1. února 2016

Termíny zápisu do studia

První předloženo

27. ledna 2014

První předloženo, které splnilo kritéria kontroly kvality

27. ledna 2014

První zveřejněno (Odhad)

29. ledna 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

23. února 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. února 2016

Naposledy ověřeno

1. února 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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