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

21 februari 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

  • 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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

175

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: GLPG0634 200 mg QD
2 tablets of 100 mg GLPG0634 in the morning
Geneesmiddel: GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
Andere namen:
  • GLPG0634-tabletten
Experimenteel: GLPG0634 100 mg QD
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
Geneesmiddel: GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
Andere namen:
  • GLPG0634-tabletten
Geneesmiddel: Placebo
placebo oral tablets, intake once daily for 20 weeks
Andere namen:
  • Placebo-tabletten
Placebo-vergelijker: Placebo QD
2 placebo tablets in the morning
Geneesmiddel: Placebo
placebo oral tablets, intake once daily for 20 weeks
Andere namen:
  • Placebo-tabletten

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of subjects achieving clinical remission at Week 10
Tijdsspanne: Week 10
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
Week 10

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of subjects achieving clinical remission
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Galapagos NV

Onderzoekers

  • Studie directeur: Pille Harrison, MD, Galapagos NV

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2014

Primaire voltooiing (Werkelijk)

1 november 2015

Studie voltooiing (Werkelijk)

1 februari 2016

Studieregistratiedata

Eerst ingediend

27 januari 2014

Eerst ingediend dat voldeed aan de QC-criteria

27 januari 2014

Eerst geplaatst (Schatting)

29 januari 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

23 februari 2016

Laatste update ingediend die voldeed aan QC-criteria

21 februari 2016

Laatst geverifieerd

1 februari 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op GLPG0634

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Voorwaarden

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Locaties

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