Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease
21. februar 2016 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
175
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Brussels, Belgia
- St. Pierre University Hospital Center
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Brussels, Belgia
- University Hospital Saint Luc
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Ghent, Belgia
- University Hospital Ghent
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Leuven, Belgia
- University Hospitals Leuven
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Liege, Belgia
- CHR de la Citadelle
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Liege, Belgia
- Clinic Saint Joseph
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Barnaul, Den russiske føderasjonen
- Territorial Clinical Hospital
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Kazan, Den russiske føderasjonen
- State Medical University
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Krasnoyarsk, Den russiske føderasjonen
- Territorial Clinical Hospital
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Moscow, Den russiske føderasjonen
- City Clinical Hospital #24
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Moscow, Den russiske føderasjonen
- A.N. Ryzhikh State Research Center for Coloproctology
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Moscow, Den russiske føderasjonen
- Moscow Clinical Research Center
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Moscow, Den russiske føderasjonen
- Vladimirsky Regional Clinical Research Institute
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Nizhny Novgorod, Den russiske føderasjonen
- Semashko Nizhny Novgorod Regional Clinical Hospital
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Novosibirsk, Den russiske føderasjonen
- City Clinical Hospital #12
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Saint Petersburg, Den russiske føderasjonen
- City Clinical Hospital #31
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Saint Petersburg, Den russiske føderasjonen
- First Pavlov State Medical University
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Saint Petersburg, Den russiske føderasjonen
- Mechnikov North-Western State Medical University
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Saint Petersburg, Den russiske føderasjonen
- St. Elizabeth City Hospital
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Clermont-Ferrand, Frankrike
- Hospital Gabriel Montpied
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Clichy, Frankrike
- Beaujon Hospital
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Dijon, Frankrike
- Dijon University Hospital Center
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Grenoble, Frankrike
- Hospital Michallon
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Lille, Frankrike
- Lille Regional University Hospital Center
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Marseille, Frankrike
- North Hospital
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Nice, Frankrike
- Archet Hospital
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Saint Etienne, Frankrike
- Saint Etienne University Hospital Center
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Bydgoszcz, Polen
- Jan Biziel University Hospital #2
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Lodz, Polen
- Saint Family Hospital Medical Center
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Tychy, Polen
- H-T. Medical Center
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Warsaw, Polen
- Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
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Warsaw, Polen
- Vivamed
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Warsaw, Polen
- Clinical Hospital of Ministry of Internal Affairs and Administration
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Wroclaw, Polen
- Active Health Center
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Bucharest, Romania
- Colentina Clinical Hospital
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Bucharest, Romania
- Fundeni Clinical Institute
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Cluj-Napoca, Romania
- Medical Center for Gastroenterology
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Timisoara, Romania
- Center for Gastroenterology, Ltd
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Birmingham, Storbritannia
- Queen Elizabeth Hospital
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Bournemouth, Storbritannia
- Royal Bournemouth Hospital
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Harrow, Storbritannia
- St Mark's Hospital
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Manchester, Storbritannia
- Manchester Royal Infirmary
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Hradec Kralove, Tsjekkisk Republikk
- Hepato-Gastroenterology HK Ltd.
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Olomouc, Tsjekkisk Republikk
- University Hospital Olomouc
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Pilsen, Tsjekkisk Republikk
- Outpatient Clinic of Internal Medicine and Gastroenterology
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Prague, Tsjekkisk Republikk
- Institute of clinical and experimental medicine
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Usti nad Labem, Tsjekkisk Republikk
- Masaryk's Hospital Usti Nad Labem
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Znojmo, Tsjekkisk Republikk
- Hospital Znojmo
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Berlin, Tyskland
- DRK Clinics Berlin Westend
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Frankfurt-am-Main, Tyskland
- Interdisciplinary Crohn Colitis Center Rhein Main
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Hamburg, Tyskland
- Asklepios West Hospital Hamburg
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Jena, Tyskland
- University Hospital Jena
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Kiel, Tyskland
- University Hospital Schleswig-Holstein
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Magdeburg, Tyskland
- University Hospital Magdeburg
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Minden, Tyskland
- Gastroenterology Group Practice Minden
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Oldenburg, Tyskland
- Internal Medicine Group Practice Oldenburg
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Balatonfured, Ungarn
- Drug Research Center Ltd.
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Budapest, Ungarn
- Semmelweis University
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Budapest, Ungarn
- ClinExpert Medical Center
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Budapest, Ungarn
- Szent Margit Hospital
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Debrecen, Ungarn
- University of Debrecen, Medical and Health Science Center
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Gyula, Ungarn
- Bekes County Pandy Kalman Hospital
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Szekszard, Ungarn
- Tolna County Balassa Janos Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: GLPG0634 200 mg QD
2 tablets of 100 mg GLPG0634 in the morning
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100 mg oral tablet, intake once daily for 20 weeks
Andre navn:
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Eksperimentell: GLPG0634 100 mg QD
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
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100 mg oral tablet, intake once daily for 20 weeks
Andre navn:
placebo oral tablets, intake once daily for 20 weeks
Andre navn:
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Placebo komparator: Placebo QD
2 placebo tablets in the morning
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placebo oral tablets, intake once daily for 20 weeks
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
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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
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Up to Week 20
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Percentage of subjects achieving endoscopic remission at Week 10
Tidsramme: Week 10
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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
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Percentage of subjects achieving endoscopic response at Week 10
Tidsramme: Week 10
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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
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Week 10
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Percentage of subjects achieving mucosal healing at Week 10
Tidsramme: Week 10
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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
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Week 10
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Change from Baseline in Crohn's Disease Activity Index score
Tidsramme: Up to Week 20
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Change from Baseline in Crohn's Disease Activity Index score, assessed at every visit
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Up to Week 20
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Change from Screening in endoscopic score
Tidsramme: Week 10
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Change from Screening in endoscopic Simplified Endoscopy Score for Crohn's Disease (SES-CD) score at Week 10
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Week 10
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Change from Screening in histopathology biopsy score
Tidsramme: Week 10
|
Change from Screening in histopathology biopsy score at Week 10
|
Week 10
|
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Change from Baseline in Subjects' Quality of Life (based on the Inflammatory Bowel Disease Questionnaire (IBDQ) questionnaire score)
Tidsramme: Up to Week 20
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Change from Baseline in Subjects' Quality of Life based on the IBDQ questionnaire score at Week 10 and Week 20
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Up to Week 20
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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)
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From screening up to 2 weeks after last dose
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The number of subjects with abnormal lab tests
Tidsramme: From screening up to 2 weeks after last dose
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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
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The number of subjects with abnormal vital signs
Tidsramme: From screening up to 2 weeks after last dose
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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
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The number of subjects with abnormal ECG
Tidsramme: From screening up to 2 weeks after last dose
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To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in electrocardiogram (ECG)
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From screening up to 2 weeks after last dose
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The plasma levels of GLPG0634 and its metabolite
Tidsramme: Up to Week 20
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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
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Up to Week 20
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The change versus Baseline in levels of immune- and inflammation-related parameters in whole blood and serum
Tidsramme: Up to Week 20
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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
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Up to Week 20
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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
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Up to Week 20
|
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The change versus Baseline in microbial communities in stool samples
Tidsramme: Up to Week 10
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To characterize the effects of GLPG0634 and its metabolite on the microbial communities by measuring the levels of predominant microbiota in stool samples
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Up to Week 10
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Pille Harrison, MD, Galapagos NV
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2014
Primær fullføring (Faktiske)
1. november 2015
Studiet fullført (Faktiske)
1. februar 2016
Datoer for studieregistrering
Først innsendt
27. januar 2014
Først innsendt som oppfylte QC-kriteriene
27. januar 2014
Først lagt ut (Anslag)
29. januar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. februar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. februar 2016
Sist bekreftet
1. februar 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GLPG0634-CL-211
- 2013-002857-32 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .