Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease
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
2 other identifiers
interventional
175
9 countries
63
Brief Summary
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2014
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2014
CompletedFirst Posted
Study publicly available on registry
January 29, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 23, 2016
February 1, 2016
1.7 years
January 27, 2014
February 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of subjects achieving clinical remission at Week 10
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score \< 150 points
Week 10
Secondary Outcomes (17)
Percentage of subjects achieving clinical remission
Up to Week 20
Percentage of subjects achieving clinical response
Up to Week 20
Percentage of subjects achieving endoscopic remission at Week 10
Week 10
Percentage of subjects achieving endoscopic response at Week 10
Week 10
Percentage of subjects achieving mucosal healing at Week 10
Week 10
- +12 more secondary outcomes
Study Arms (3)
GLPG0634 200 mg QD
EXPERIMENTAL2 tablets of 100 mg GLPG0634 in the morning
GLPG0634 100 mg QD
EXPERIMENTAL1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
Placebo QD
PLACEBO COMPARATOR2 placebo tablets in the morning
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galapagos NVlead
Study Sites (63)
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
Related Publications (2)
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.
PMID: 35762272DERIVEDVermeire 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.
PMID: 27988142DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pille Harrison, MD
Galapagos NV
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2014
First Posted
January 29, 2014
Study Start
February 1, 2014
Primary Completion
November 1, 2015
Study Completion
February 1, 2016
Last Updated
February 23, 2016
Record last verified: 2016-02