Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis
- Registration Number
- NCT01829321
- Lead Sponsor
- Galapagos NV
- Brief Summary
* Approximately 45 patients suffering from mild to moderate ulcerative colitis will be examined for any side effects (safety and tolerability) that may occur when taking GLPG0974 or matching placebo (2:1 ratio) for 28 days.
* During the course of the study, patients will also be evaluated for improvement of disease activity by different efficacy measures, the amount of GLPG0974 present in the blood determined (PK) and the effects of GLPG0974 on selected biomarkers (PD) in the blood, colon biopsies and faeces will be explored.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- Men or women between 18 to 75 years of age inclusive, on the day of signing the informed consent with a documented history of UC.
- Presence of mild-to-moderately active ulcerative colitis as evidenced by clinical signs and endoscopy.
- Medication: 5-ASA.
- Absence of infectious colitis.
Key
- History of sensitivity to any component of the study drug
- Any concurrent illness, condition, disability or clinically significant abnormality (including lab tests) that represents a safety risk , may affect the interpretation of data, or may prevent the subject to safely complete the assessments
- Positive serology for HIV 1 or 2 or hepatitis B or C, or any history of HIV or hepatitis.
- History of active infections requiring intravenous antibiotics within the past four weeks prior to randomization.
- History of bowel surgery, or presence or history of intestinal malignancy.
- Suspicion of Crohn's disease, indeterminate colitis, microscopic colitis, ischaemic colitis or radiation-induced colitis.
- History of lower GI bleeding disorder, other than UC.
- A history of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal (other than UC), pulmonary or metabolic disease.
- History of tuberculosis (TB) infection.
- Treatment with systemic corticosteroids within 1 week prior to randomization.
- Treatment with TNF-α inhibitors or other biologics within 2 months prior to randomization.
- Treatment with immunosuppressants, initiated or changed within 3 months prior to randomization .
- Current use of probiotic or prebiotic preparations
- Regular daily use of NSAIDs, within 7 days prior to randomization.
- Administration of any experimental therapy within 90 days or 5x the half-life.
- History of drug or alcohol abuse.
- Pregnant or lactating women.
- Medical, psychiatric, cognitive, or other conditions that compromise the subject's ability to complete the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 1 capsule placebo twice daily GLPG0974 GLPG0974 1 capsule of 200 mg GLPG0974 twice daily
- Primary Outcome Measures
Name Time Method Number of adverse events Screening up to Follow up (14 days after last dosing) To evaluate the safety and tolerability of GLPG0974 in terms of the number of adverse events reported
Changes in physical exam measures Screening up to Follow up (14 days after last dosing) To evaluate the safety and tolerability of GLPG0974 in terms of the changes in physical exam measures reported
Changes in vital signs as measured by heart rate, blood pressure and oral temperature Screening up to Follow up (14 days after last dosing) To evaluate the safety and tolerability of GLPG0974 in terms of the changes in vital signs as measured by heart rate, blood pressure and oral temperature reported
Changes in 12-lead ECG measures Screening up to Follow up (14 days after last dosing) To evaluate the safety and tolerability of GLPG0974 in terms of the changes in 12-lead ECG measures reported
Changes in blood safety lab parameters Screening up to Follow up (14 days after last dosing) To evaluate the safety and tolerability of GLPG0974 in terms of changes in blood safety lab parameters reported
Changes in urine safety lab parameters Screening up to Follow up (14 days after last dosing) To evaluate the safety and tolerability of GLPG0974 in terms of changes in urine safety lab parameters reported
- Secondary Outcome Measures
Name Time Method Changes in (partial) Mayo clinical disease activity score From Day 1 to Day 29 To evaluate the efficacy of GLPG0974 in terms of changes in (partial) Mayo clinical disease activity score reported
Changes in histopathological clinical activity score in colon biopsies Day 1 and Day 29 To evaluate the efficacy of GLPG0974 in terms of changes in histopathological clinical activity score (Geboes score) in colon biopsies reported
The amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974 Day 8, Day 15 and Day 29 To evaluate the amount of GLPG0974 in plasma over time after multiple oral doses of GLPG0974 - pharmacokinetics (PK) in ulcerative colitis patients
Changes in the levels of faecal calprotectin over time after multiple oral doses of GLPG0974 Screening up to Day 29 To evaluate the changes in the levels of calprotectin in faeces over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients
Changes in the levels of C-reactive protein in serum over time after multiple oral doses of GLPG0974 Screening up to Day 29 To evaluate the changes in the levels of C-reactive protein in serum over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients
Changes in the levels of myeloperoxidase (MPO) in colon biopsies over time after multiple oral doses of GLPG0974 Day 1 and Day 29 To evaluate the changes in the levels of MPO in colon biopsies over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients
Changes in the levels of predominant microbiota in faeces over time after multiple oral doses of GLPG0974 Day 1 and Day 29 To evaluate the changes in the levels of predominant microbiota in faeces over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients
Changes in the levels of predominant microbiota in colon biopsies over time after multiple oral doses of GLPG0974 Day 1 and Day 29 To evaluate the changes in the levels of predominant microbiota in colon biopsies over time after multiple oral doses of GLPG0974 - pharmacodynamics (PD) in ulcerative colitis patients
Trial Locations
- Locations (16)
Rīgas slimnīca Bikor Holim
🇱🇻Riga, Latvia
Fakulní nemocnice Olomouc
🇨🇿Olomouc, Czech Republic
Latvijas Jūras Medicīnas Centrs
🇱🇻Riga, Latvia
UZ Leuven
🇧🇪Leuven, Belgium
Homolka Hospitál
🇨🇿Prague, Czech Republic
Nemocnice Slaný
🇨🇿Slany, Czech Republic
Imelda
🇧🇪Bonheiden, Belgium
AZ Groeninge
🇧🇪Kortrijk, Belgium
Hepato-Gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, Czech Republic
SIA Gremošanas slimību centrs "Gastro"
🇱🇻Riga, Latvia
Univerzitná nemocnica Bratislava
🇸🇰Bratislava, Slovakia
Fakultná Nemocnica Nitra
🇸🇰Nitra, Slovakia
Krajská zdravotní a.s., Masarykova nemocnice v Ústí nad Labem T. Bati a.s.
🇨🇿Usti nad Labem, Czech Republic
UZ Gent
🇧🇪Gent, Belgium
Nemocnice Znojmo
🇨🇿Znojmo, Czech Republic
Krajská nemocnice Tomáše Bati - Zlin
🇨🇿Zlin, Czech Republic