Clinical trial NCT02337608: Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis
Official title: Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate to Severe Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: moderate to severe ulcerative colitis
GLPG1205
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Approximately 60 patients suffering from moderate to severe ulcerative colitis will be evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or matching placebo once daily for 12 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 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.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects between 18 and 75 years
* 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:

* History of sensitivity to any component of the study drug, or a history of drug or other allergy
* 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

Primary outcomes:
measure: Changes in Mayo score at Week 8
timeFrame: Screening and Week 8
Secondary outcomes:
measure: Changes in partial Mayo score
timeFrame: From Screening to Week 12
measure: Histological response rate
timeFrame: Screening and Week 8
measure: Number of subjects with adverse events
timeFrame: From Screening to Week 16
measure: Number of subjects with abnormal laboratory parameters
timeFrame: From Screening to Week 16
measure: Number of subjects with abnormal vital signs
timeFrame: From Screening to Week 16
measure: Number of subjects with abnormal electrocardiogram
timeFrame: From Screening to Week 16
measure: Number of subjects with abnormal physical examination
timeFrame: From Screening to Week 16
measure: The plasma levels of GLPG1205
timeFrame: Week 4, 8 and 12
measure: Changes in serum C-reactive protein (CRP) levels
timeFrame: From Screening to Week 16
measure: Changes in faecal calprotectin levels
timeFrame: From Screening to Week 12
measure: Changes in myeloperoxidase (MPO) levels in colonic biopsies
timeFrame: Screening and Week 8
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: St. Pierre University Hospital Center
city: Leuven
country: Belgium
facility: Leuven University Hospital
city: Liege
country: Belgium
facility: Clinic Saint-Joseph
city: Hradec Kralove
country: Czech Republic
facility: Hepato-Gastroenterology HK Ltd.
city: Pilsen
country: Czech Republic
facility: Outpatient Clinic of Internal Medicine and Gastroenterology
city: Usti nad Orlici
country: Czech Republic
facility: Orlickoustecka Hospital, Inc.
city: Zlin
country: Czech Republic
facility: Regional Hospital T. Bata, Clinic of Internal Medicine
city: Znojmo
country: Czech Republic
facility: Hospital Znojmo
city: Berlin
country: Germany
facility: Gastroenterology Specialist Practice
city: Hamburg
country: Germany
facility: Asklepios West Hospital Hamburg, Clinic of Internal Medicine
city: Hannover
country: Germany
facility: Hannover Medical School
city: Jena
country: Germany
facility: University Hospital Jena
city: Minden
country: Germany
facility: Gastroenterology Group Practice Minden
city: Muenster
country: Germany
facility: Gastroenterology Practice at Germania-Campus
city: Oldenburg
country: Germany
facility: Internal Medicine Group Practice Oldenburg
city: Budapest
country: Hungary
facility: Clinexpert Medical Center
city: Budapest
country: Hungary
facility: Hungarian Center for Obesity Ltd.
city: Budapest
country: Hungary
facility: Medical Centre, Hungarian Defence Forces
city: Budapest
country: Hungary
facility: Szent Margit Hospital
city: Debrecen
country: Hungary
facility: Main Railway Outpatient Clinic Debrecen
city: Vac
country: Hungary
facility: Javorszky Odon Hospital
city: Ksawerow
country: Poland
facility: Healthcare Center Orkan Med Stec Michalska Spolka Jawna
city: Lodz
country: Poland
facility: Saint Family Hospital Medical Center
city: Sopot
country: Poland
facility: Sopmed Llc
city: Tychy
country: Poland
facility: H-T Medical Center
city: Warsaw
country: Poland
facility: Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
city: Warsaw
country: Poland
facility: Vivamed
city: Wroclaw
country: Poland
facility: Active Health Center, Non-Public Healthcare Facility Zawidawie Center
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Krasnoyarsk
country: Russian Federation
facility: Territorial Clinical Hospital
city: Moscow
country: Russian Federation
facility: Central Research Institute of Gastroenterology
city: Moscow
country: Russian Federation
facility: Moscow Vladimirsky Regional Clinical Research Institute
city: Nizhny Novgorod
country: Russian Federation
facility: Semashko Nizhny Novgorod Regional Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital #12
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital n.a. N. N. Burdenko
city: Saint Petersburg
country: Russian Federation
facility: City Clinical Hospital #31
city: Saint Petersburg
country: Russian Federation
facility: City General Hospital #2
city: Saint Petersburg
country: Russian Federation
facility: St. Venerable Martyress Elizabeth Municipal Hospital
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical University
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
References: