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

21. februar 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  • 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

175

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Den Russiske Føderation
      • Barnaul, Den Russiske Føderation
        • Territorial Clinical Hospital
      • Kazan, Den Russiske Føderation
        • State Medical University
      • Krasnoyarsk, Den Russiske Føderation
        • Territorial Clinical Hospital
      • Moscow, Den Russiske Føderation
        • City Clinical Hospital #24
      • Moscow, Den Russiske Føderation
        • A.N. Ryzhikh State Research Center for Coloproctology
      • Moscow, Den Russiske Føderation
        • Moscow Clinical Research Center
      • Moscow, Den Russiske Føderation
        • Vladimirsky Regional Clinical Research Institute
      • Nizhny Novgorod, Den Russiske Føderation
        • Semashko Nizhny Novgorod Regional Clinical Hospital
      • Novosibirsk, Den Russiske Føderation
        • City Clinical Hospital #12
      • Saint Petersburg, Den Russiske Føderation
        • City Clinical Hospital #31
      • Saint Petersburg, Den Russiske Føderation
        • First Pavlov State Medical University
      • Saint Petersburg, Den Russiske Føderation
        • Mechnikov North-Western State Medical University
      • Saint Petersburg, Den Russiske Føderation
        • St. Elizabeth City Hospital
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige
        • Queen Elizabeth Hospital
      • Bournemouth, Det Forenede Kongerige
        • Royal Bournemouth Hospital
      • Harrow, Det Forenede Kongerige
        • St Mark's Hospital
      • Manchester, Det Forenede Kongerige
        • Manchester Royal Infirmary
  • Frankrig
      • Clermont-Ferrand, Frankrig
        • Hospital Gabriel Montpied
      • Clichy, Frankrig
        • Beaujon Hospital
      • Dijon, Frankrig
        • Dijon University Hospital Center
      • Grenoble, Frankrig
        • Hospital Michallon
      • Lille, Frankrig
        • Lille Regional University Hospital Center
      • Marseille, Frankrig
        • North Hospital
      • Nice, Frankrig
        • Archet Hospital
      • Saint Etienne, Frankrig
        • 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
  • Rumænien
      • Bucharest, Rumænien
        • Colentina Clinical Hospital
      • Bucharest, Rumænien
        • Fundeni Clinical Institute
      • Cluj-Napoca, Rumænien
        • Medical Center for Gastroenterology
      • Timisoara, Rumænien
        • Center for Gastroenterology, Ltd
  • Tjekkiet
      • Hradec Kralove, Tjekkiet
        • Hepato-Gastroenterology HK Ltd.
      • Olomouc, Tjekkiet
        • University Hospital Olomouc
      • Pilsen, Tjekkiet
        • Outpatient Clinic of Internal Medicine and Gastroenterology
      • Prague, Tjekkiet
        • Institute of Clinical and Experimental Medicine
      • Usti nad Labem, Tjekkiet
        • Masaryk's Hospital Usti Nad Labem
      • Znojmo, Tjekkiet
        • Hospital Znojmo
  • Tyskland
      • Berlin, Tyskland
        • DRK Clinics Berlin Westend
      • Frankfurt-am-Main, Tyskland
        • Interdisciplinary Crohn Colitis Center Rhein Main
      • Hamburg, Tyskland
        • Asklepios West Hospital Hamburg
      • Jena, Tyskland
        • University Hospital Jena
      • Kiel, Tyskland
        • University Hospital Schleswig-Holstein
      • Magdeburg, Tyskland
        • University Hospital Magdeburg
      • Minden, Tyskland
        • Gastroenterology Group Practice Minden
      • Oldenburg, Tyskland
        • Internal Medicine Group Practice Oldenburg
  • 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 János Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: GLPG0634 200 mg QD
2 tablets of 100 mg GLPG0634 in the morning
Medicin: GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
Andre navne:
  • GLPG0634 tablets
Eksperimentel: GLPG0634 100 mg QD
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
Medicin: GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
Andre navne:
  • GLPG0634 tablets
Medicin: Placebo
placebo oral tablets, intake once daily for 20 weeks
Andre navne:
  • Placebo tabletter
Placebo komparator: Placebo QD
2 placebo tablets in the morning
Medicin: Placebo
placebo oral tablets, intake once daily for 20 weeks
Andre navne:
  • Placebo tabletter

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of subjects achieving clinical remission at Week 10
Tidsramme: Week 10
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
Week 10

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of subjects achieving clinical remission
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Galapagos NV

Efterforskere

  • Studieleder: Pille Harrison, MD, Galapagos NV

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2014

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

27. januar 2014

Først indsendt, der opfyldte QC-kriterier

27. januar 2014

Først opslået (Skøn)

29. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Crohns sygdom

Kliniske forsøg med GLPG0634

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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