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

21. Februar 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

  • 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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

175

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Belgien
      • Brussels, Belgien
        • St. Pierre University Hospital Center
      • Brussels, Belgien
        • University Hospital Saint Luc
      • Ghent, Belgien
        • University Hospital Ghent
      • Leuven, Belgien
        • University Hospitals Leuven
      • Liege, Belgien
        • CHR de la Citadelle
      • Liege, Belgien
        • Clinic Saint Joseph
  • Deutschland
      • Berlin, Deutschland
        • DRK Clinics Berlin Westend
      • Frankfurt-am-Main, Deutschland
        • Interdisciplinary Crohn Colitis Center Rhein Main
      • Hamburg, Deutschland
        • Asklepios West Hospital Hamburg
      • Jena, Deutschland
        • University Hospital Jena
      • Kiel, Deutschland
        • University Hospital Schleswig-Holstein
      • Magdeburg, Deutschland
        • University Hospital Magdeburg
      • Minden, Deutschland
        • Gastroenterology Group Practice Minden
      • Oldenburg, Deutschland
        • Internal Medicine Group Practice Oldenburg
  • Frankreich
      • Clermont-Ferrand, Frankreich
        • Hospital Gabriel Montpied
      • Clichy, Frankreich
        • Beaujon Hospital
      • Dijon, Frankreich
        • Dijon University Hospital Center
      • Grenoble, Frankreich
        • Hospital Michallon
      • Lille, Frankreich
        • Lille Regional University Hospital Center
      • Marseille, Frankreich
        • North Hospital
      • Nice, Frankreich
        • Archet Hospital
      • Saint Etienne, Frankreich
        • Saint Etienne University Hospital Center
  • 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
  • Rumänien
      • Bucharest, Rumänien
        • Colentina Clinical Hospital
      • Bucharest, Rumänien
        • Fundeni Clinical Institute
      • Cluj-Napoca, Rumänien
        • Medical Center for Gastroenterology
      • Timisoara, Rumänien
        • Center for Gastroenterology, Ltd
  • Russische Föderation
      • Barnaul, Russische Föderation
        • Territorial Clinical Hospital
      • Kazan, Russische Föderation
        • State Medical University
      • Krasnoyarsk, Russische Föderation
        • Territorial Clinical Hospital
      • Moscow, Russische Föderation
        • City Clinical Hospital #24
      • Moscow, Russische Föderation
        • A.N. Ryzhikh State Research Center for Coloproctology
      • Moscow, Russische Föderation
        • Moscow Clinical Research Center
      • Moscow, Russische Föderation
        • Vladimirsky Regional Clinical Research Institute
      • Nizhny Novgorod, Russische Föderation
        • Semashko Nizhny Novgorod Regional Clinical Hospital
      • Novosibirsk, Russische Föderation
        • City Clinical Hospital #12
      • Saint Petersburg, Russische Föderation
        • City Clinical Hospital #31
      • Saint Petersburg, Russische Föderation
        • First Pavlov State Medical University
      • Saint Petersburg, Russische Föderation
        • Mechnikov North-Western State Medical University
      • Saint Petersburg, Russische Föderation
        • St. Elizabeth City Hospital
  • Tschechische Republik
      • Hradec Kralove, Tschechische Republik
        • Hepato-Gastroenterology HK Ltd.
      • Olomouc, Tschechische Republik
        • University Hospital Olomouc
      • Pilsen, Tschechische Republik
        • Outpatient Clinic of Internal Medicine and Gastroenterology
      • Prague, Tschechische Republik
        • Institute of clinical and experimental medicine
      • Usti nad Labem, Tschechische Republik
        • Masaryk's Hospital Usti Nad Labem
      • Znojmo, Tschechische Republik
        • Hospital Znojmo
  • Ungarn
      • Balatonfured, Ungarn
        • Drug Research Center Ltd.
      • Budapest, Ungarn
        • Semmelweis University
      • Budapest, Ungarn
        • ClinExpert Medical Center
      • Budapest, Ungarn
        • Szent Margit Hospital
      • Debrecen, Ungarn
        • University of Debrecen, Medical and Health Science Center
      • Gyula, Ungarn
        • Bekes County Pandy Kalman Hospital
      • Szekszard, Ungarn
        • Tolna County Balassa Janos Hospital
  • Vereinigtes Königreich
      • Birmingham, Vereinigtes Königreich
        • Queen Elizabeth Hospital
      • Bournemouth, Vereinigtes Königreich
        • Royal Bournemouth Hospital
      • Harrow, Vereinigtes Königreich
        • St Mark's Hospital
      • Manchester, Vereinigtes Königreich
        • Manchester Royal Infirmary

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: GLPG0634 200 mg QD
2 tablets of 100 mg GLPG0634 in the morning
Arzneimittel: GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
Andere Namen:
  • GLPG0634 Tabletten
Experimental: GLPG0634 100 mg QD
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
Arzneimittel: GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
Andere Namen:
  • GLPG0634 Tabletten
Arzneimittel: Placebo
placebo oral tablets, intake once daily for 20 weeks
Andere Namen:
  • Placebo-Tabletten
Placebo-Komparator: Placebo QD
2 placebo tablets in the morning
Arzneimittel: Placebo
placebo oral tablets, intake once daily for 20 weeks
Andere Namen:
  • Placebo-Tabletten

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of subjects achieving clinical remission at Week 10
Zeitfenster: Week 10
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
Week 10

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of subjects achieving clinical remission
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Galapagos NV

Ermittler

  • Studienleiter: Pille Harrison, MD, Galapagos NV

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2014

Primärer Abschluss (Tatsächlich)

1. November 2015

Studienabschluss (Tatsächlich)

1. Februar 2016

Studienanmeldedaten

Zuerst eingereicht

27. Januar 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Januar 2014

Zuerst gepostet (Schätzen)

29. Januar 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

23. Februar 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Februar 2016

Zuletzt verifiziert

1. Februar 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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