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

Key Inclusion Criteria:

• 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 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.