Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease
sunnuntai 21. helmikuuta 2016 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
- 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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
175
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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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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Bydgoszcz, Puola
- Jan Biziel University Hospital #2
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Lodz, Puola
- Saint Family Hospital Medical Center
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Tychy, Puola
- H-T. Medical Center
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Warsaw, Puola
- Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
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Warsaw, Puola
- Vivamed
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Warsaw, Puola
- Clinical Hospital of Ministry of Internal Affairs and Administration
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Wroclaw, Puola
- Active Health Center
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Clermont-Ferrand, Ranska
- Hospital Gabriel Montpied
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Clichy, Ranska
- Beaujon Hospital
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Dijon, Ranska
- Dijon University Hospital Center
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Grenoble, Ranska
- Hospital Michallon
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Lille, Ranska
- Lille Regional University Hospital Center
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Marseille, Ranska
- North Hospital
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Nice, Ranska
- Archet Hospital
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Saint Etienne, Ranska
- Saint Etienne University Hospital 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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Berlin, Saksa
- DRK Clinics Berlin Westend
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Frankfurt-am-Main, Saksa
- Interdisciplinary Crohn Colitis Center Rhein Main
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Hamburg, Saksa
- Asklepios West Hospital Hamburg
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Jena, Saksa
- University Hospital Jena
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Kiel, Saksa
- University Hospital Schleswig-Holstein
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Magdeburg, Saksa
- University Hospital Magdeburg
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Minden, Saksa
- Gastroenterology Group Practice Minden
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Oldenburg, Saksa
- Internal Medicine Group Practice Oldenburg
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Hradec Kralove, Tšekin tasavalta
- Hepato-Gastroenterology HK Ltd.
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Olomouc, Tšekin tasavalta
- University Hospital Olomouc
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Pilsen, Tšekin tasavalta
- Outpatient Clinic of Internal Medicine and Gastroenterology
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Prague, Tšekin tasavalta
- Institute of clinical and experimental medicine
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Usti nad Labem, Tšekin tasavalta
- Masaryk's Hospital Usti Nad Labem
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Znojmo, Tšekin tasavalta
- Hospital Znojmo
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Balatonfured, Unkari
- Drug Research Center Ltd.
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Budapest, Unkari
- Semmelweis University
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Budapest, Unkari
- ClinExpert Medical Center
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Budapest, Unkari
- Szent Margit Hospital
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Debrecen, Unkari
- University of Debrecen, Medical and Health Science Center
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Gyula, Unkari
- Bekes County Pandy Kalman Hospital
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Szekszard, Unkari
- Tolna County Balassa Janos Hospital
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Barnaul, Venäjän federaatio
- Territorial Clinical Hospital
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Kazan, Venäjän federaatio
- State Medical University
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Krasnoyarsk, Venäjän federaatio
- Territorial Clinical Hospital
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Moscow, Venäjän federaatio
- City Clinical Hospital #24
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Moscow, Venäjän federaatio
- A.N. Ryzhikh State Research Center for Coloproctology
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Moscow, Venäjän federaatio
- Moscow Clinical Research Center
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Moscow, Venäjän federaatio
- Vladimirsky Regional Clinical Research Institute
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Nizhny Novgorod, Venäjän federaatio
- Semashko Nizhny Novgorod Regional Clinical Hospital
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Novosibirsk, Venäjän federaatio
- City Clinical Hospital #12
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Saint Petersburg, Venäjän federaatio
- City Clinical Hospital #31
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Saint Petersburg, Venäjän federaatio
- First Pavlov State Medical University
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Saint Petersburg, Venäjän federaatio
- Mechnikov North-Western State Medical University
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Saint Petersburg, Venäjän federaatio
- St. Elizabeth City Hospital
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Birmingham, Yhdistynyt kuningaskunta
- Queen Elizabeth Hospital
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Bournemouth, Yhdistynyt kuningaskunta
- Royal Bournemouth Hospital
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Harrow, Yhdistynyt kuningaskunta
- St Mark's Hospital
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Manchester, Yhdistynyt kuningaskunta
- Manchester Royal Infirmary
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 75 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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
Muut nimet:
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Kokeellinen: 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
Muut nimet:
placebo oral tablets, intake once daily for 20 weeks
Muut nimet:
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Placebo Comparator: Placebo QD
2 placebo tablets in the morning
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placebo oral tablets, intake once daily for 20 weeks
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Percentage of subjects achieving clinical remission at Week 10
Aikaikkuna: Week 10
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Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
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Week 10
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Percentage of subjects achieving clinical remission
Aikaikkuna: Up to Week 20
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Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points, assessed at every visit
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Up to Week 20
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Percentage of subjects achieving clinical response
Aikaikkuna: 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
Aikaikkuna: 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
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Week 10
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Percentage of subjects achieving endoscopic response at Week 10
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Week 10
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Change from Screening in histopathology biopsy score at Week 10
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Week 10
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Change from Baseline in Subjects' Quality of Life (based on the Inflammatory Bowel Disease Questionnaire (IBDQ) questionnaire score)
Aikaikkuna: 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
Aikaikkuna: 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 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
Aikaikkuna: 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
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From screening up to 2 weeks after last dose
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The number of subjects with abnormal vital signs
Aikaikkuna: 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
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From screening up to 2 weeks after last dose
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The number of subjects with abnormal ECG
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Up to Week 20
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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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: Pille Harrison, MD, Galapagos NV
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Lauantai 1. helmikuuta 2014
Ensisijainen valmistuminen (Todellinen)
Sunnuntai 1. marraskuuta 2015
Opintojen valmistuminen (Todellinen)
Maanantai 1. helmikuuta 2016
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 27. tammikuuta 2014
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 27. tammikuuta 2014
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 29. tammikuuta 2014
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Tiistai 23. helmikuuta 2016
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Sunnuntai 21. helmikuuta 2016
Viimeksi vahvistettu
Maanantai 1. helmikuuta 2016
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- GLPG0634-CL-211
- 2013-002857-32 (EudraCT-numero)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .