Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis
NCT ID: NCT02337608
Last Updated: 2015-11-20
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
64 participants
INTERVENTIONAL
2014-12-31
2015-11-30
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 GLPG1205 present in the blood (Pharmacokinetics) as well as the effects of GLPG1205 on disease- and mechanism of action-related parameters (Pharmacodynamics) in blood, stool and colonic biopsies will be determined.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GLPG1205 100mg QD
GLPG1205 100mg daily dosing in the morning
GLPG1205
GLPG1205 daily dosing in the morning for 12 weeks
Placebo
Placebo daily dosing in the morning
Placebo
placebo daily dosing in the morning daily for 12 weeks
Interventions
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GLPG1205
GLPG1205 daily dosing in the morning for 12 weeks
Placebo
placebo daily dosing in the morning daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Documented history of UC
* Presence of active UC for a minimum period of 14 days prior to screening and spread beyond the rectum, Mayo score ≥ 6 with rectal bleeding score ≥ 1 and endoscopy score ≥ 2
* Absence of infectious colitis
* Tumor necrosis factor alpha (TNFα) inhibitor-naive subjects should have failed at least 1 prior conventional therapy
* Continuation of concurrent treatment with oral steroids (≤30 mg prednisolone eq/day), immunosuppressants and 5-aminosalicylates at stable dose is allowed
* Female subjects must have a negative blood pregnancy test, unless they are surgically sterile, had a hysterectomy, or have been postmenopausal for at least 1 year
* Subjects will have to use highly effective contraceptive methods
Exclusion Criteria
* Any concurrent illness, condition, disability, or clinically significant abnormality that, in the investigator's opinion, represents a safety risk for the subject's participation, may affect the interpretation of data, or may prevent the subject from safely completing the assessments
* History of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, GI (other than UC), pulmonary, or metabolic disease
* History of active infections requiring intravenous antibiotics within the past 4 weeks prior to screening.
* History of malignancy within the past 5 years; presence or history of intestinal malignancy
* History of bowel surgery within 6 months prior to screening; history of colon resection with \< 30 cm of the colon remaining
* Suspicion of Crohn's disease, indeterminate colitis, microscopic colitis, ischemic colitis, diverticular disease-associated colitis, or radiation-induced colitis
* Subject who has received non-permitted UC therapies within specified timeframes, depending on the medication, as stated in the protocol
* Subject who is pregnant or lactating
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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Frédéric Vanhoutte, MD
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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St. Pierre University Hospital Center
Brussels, , Belgium
Leuven University Hospital
Leuven, , Belgium
Clinic Saint-Joseph
Liège, , Belgium
Hepato-Gastroenterology HK Ltd.
Hradec Králové, , Czechia
Outpatient Clinic of Internal Medicine and Gastroenterology
Pilsen, , Czechia
Orlickoustecka Hospital, Inc.
Ústí nad Orlicí, , Czechia
Regional Hospital T. Bata, Clinic of Internal Medicine
Zlín, , Czechia
Hospital Znojmo
Znojmo, , Czechia
Gastroenterology Specialist Practice
Berlin, , Germany
Asklepios West Hospital Hamburg, Clinic of Internal Medicine
Hamburg, , Germany
Hannover Medical School
Hanover, , Germany
University Hospital Jena
Jena, , Germany
Gastroenterology Group Practice Minden
Minden, , Germany
Gastroenterology Practice at Germania-Campus
Münster, , Germany
Internal Medicine Group Practice Oldenburg
Oldenburg, , Germany
Clinexpert Medical Center
Budapest, , Hungary
Hungarian Center for Obesity Ltd.
Budapest, , Hungary
Medical Centre, Hungarian Defence Forces
Budapest, , Hungary
Szent Margit Hospital
Budapest, , Hungary
Main Railway Outpatient Clinic Debrecen
Debrecen, , Hungary
Javorszky Odon Hospital
Vác, , Hungary
Healthcare Center Orkan Med Stec Michalska Spolka Jawna
Ksawerów, , Poland
Saint Family Hospital Medical Center
Lodz, , Poland
Sopmed Llc
Sopot, , Poland
H-T Medical Center
Tychy, , Poland
Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
Warsaw, , Poland
Vivamed
Warsaw, , Poland
Active Health Center, Non-Public Healthcare Facility Zawidawie Center
Wroclaw, , Poland
Kazan State Medical University
Kazan', , Russia
Territorial Clinical Hospital
Krasnoyarsk, , Russia
Central Research Institute of Gastroenterology
Moscow, , Russia
Moscow Vladimirsky Regional Clinical Research Institute
Moscow, , Russia
Semashko Nizhny Novgorod Regional Clinical Hospital
Nizhny Novgorod, , Russia
City Clinical Hospital #12
Novosibirsk, , Russia
Penza Regional Clinical Hospital n.a. N. N. Burdenko
Penza, , Russia
City Clinical Hospital #31
Saint Petersburg, , Russia
City General Hospital #2
Saint Petersburg, , Russia
St. Venerable Martyress Elizabeth Municipal Hospital
Saint Petersburg, , Russia
Stavropol State Medical University
Stavropol, , Russia
Countries
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Other Identifiers
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2014-001893-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GLPG1205-CL-211
Identifier Type: -
Identifier Source: org_study_id