Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease
NCT ID: NCT02048618
Last Updated: 2016-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
175 participants
INTERVENTIONAL
2014-02-28
2016-02-29
Brief Summary
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* 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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GLPG0634 200 mg QD
2 tablets of 100 mg GLPG0634 in the morning
GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
GLPG0634 100 mg QD
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
Placebo
placebo oral tablets, intake once daily for 20 weeks
Placebo QD
2 placebo tablets in the morning
Placebo
placebo oral tablets, intake once daily for 20 weeks
Interventions
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GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
Placebo
placebo oral tablets, intake once daily for 20 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Pille Harrison, MD
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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St. Pierre University Hospital Center
Brussels, , Belgium
University Hospital Saint Luc
Brussels, , Belgium
University Hospital Ghent
Ghent, , Belgium
University Hospitals Leuven
Leuven, , Belgium
CHR de la Citadelle
Liège, , Belgium
Clinic Saint Joseph
Liège, , Belgium
Hepato-Gastroenterology HK Ltd.
Hradec Králové, , Czechia
University Hospital Olomouc
Olomouc, , Czechia
Outpatient Clinic of Internal Medicine and Gastroenterology
Pilsen, , Czechia
Institute of Clinical and Experimental Medicine
Prague, , Czechia
Masaryk's Hospital Usti Nad Labem
Ústí nad Labem, , Czechia
Hospital Znojmo
Znojmo, , Czechia
Hospital Gabriel Montpied
Clermont-Ferrand, , France
Beaujon Hospital
Clichy, , France
Dijon University Hospital Center
Dijon, , France
Hospital Michallon
Grenoble, , France
Lille Regional University Hospital Center
Lille, , France
North Hospital
Marseille, , France
Archet Hospital
Nice, , France
Saint Etienne University Hospital Center
Saint-Etienne, , France
DRK Clinics Berlin Westend
Berlin, , Germany
Interdisciplinary Crohn Colitis Center Rhein Main
Frankfurt am Main, , Germany
Asklepios West Hospital Hamburg
Hamburg, , Germany
University Hospital Jena
Jena, , Germany
University Hospital Schleswig-Holstein
Kiel, , Germany
University Hospital Magdeburg
Magdeburg, , Germany
Gastroenterology Group Practice Minden
Minden, , Germany
Internal Medicine Group Practice Oldenburg
Oldenburg, , Germany
Drug Research Center Ltd.
Balatonfüred, , Hungary
Clinexpert Medical Center
Budapest, , Hungary
Semmelweis University
Budapest, , Hungary
Szent Margit Hospital
Budapest, , Hungary
University of Debrecen, Medical and Health Science Center
Debrecen, , Hungary
Bekes County Pandy Kalman Hospital
Gyula, , Hungary
Tolna County Balassa Janos Hospital
Szekszárd, , Hungary
Jan Biziel University Hospital #2
Bydgoszcz, , Poland
Saint Family Hospital Medical Center
Lodz, , Poland
H-T. Medical Center
Tychy, , Poland
Clinical Hospital of Ministry of Internal Affairs and Administration
Warsaw, , Poland
Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
Warsaw, , Poland
Vivamed
Warsaw, , Poland
Active Health Center
Wroclaw, , Poland
Colentina Clinical Hospital
Bucharest, , Romania
Fundeni Clinical Institute
Bucharest, , Romania
Medical Center for Gastroenterology
Cluj-Napoca, , Romania
Center for Gastroenterology, Ltd
Timișoara, , Romania
Territorial Clinical Hospital
Barnaul, , Russia
State Medical University
Kazan', , Russia
Territorial Clinical Hospital
Krasnoyarsk, , Russia
A.N. Ryzhikh State Research Center for Coloproctology
Moscow, , Russia
City Clinical Hospital #24
Moscow, , Russia
Moscow Clinical Research Center
Moscow, , Russia
Vladimirsky Regional Clinical Research Institute
Moscow, , Russia
Semashko Nizhny Novgorod Regional Clinical Hospital
Nizhny Novgorod, , Russia
City Clinical Hospital #12
Novosibirsk, , Russia
City Clinical Hospital #31
Saint Petersburg, , Russia
First Pavlov State Medical University
Saint Petersburg, , Russia
Mechnikov North-Western State Medical University
Saint Petersburg, , Russia
St. Elizabeth City Hospital
Saint Petersburg, , Russia
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
St Mark's Hospital
Harrow, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
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References
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Reinisch W, Serone A, Hebuterne X, Kuhbacher T, Klopocka M, Roblin X, Brodbeck J, Etchevers K, Galien R, Grant E, Tasset C, Yoon OK, Zaboli S, Vermeire S. Mucosal p-STAT1/3 correlates with histologic disease activity in Crohn's disease and is responsive to filgotinib. Tissue Barriers. 2023 Apr 3;11(2):2088961. doi: 10.1080/21688370.2022.2088961. Epub 2022 Jun 28.
Vermeire S, Schreiber S, Petryka R, Kuehbacher T, Hebuterne X, Roblin X, Klopocka M, Goldis A, Wisniewska-Jarosinska M, Baranovsky A, Sike R, Stoyanova K, Tasset C, Van der Aa A, Harrison P. Clinical remission in patients with moderate-to-severe Crohn's disease treated with filgotinib (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial. Lancet. 2017 Jan 21;389(10066):266-275. doi: 10.1016/S0140-6736(16)32537-5. Epub 2016 Dec 15.
Other Identifiers
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2013-002857-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GLPG0634-CL-211
Identifier Type: -
Identifier Source: org_study_id
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