Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis

Exclusion Criteria

• •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.