A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis

Exclusion Criteria

• •Subject has a diagnosis of inflammatory bowel disease -unclassified or indeterminate colitis, isolated proctitis, or toxic megacolon.
• •Subject has an active infection.
• •Subject with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement).
• •Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria).
• •Subject has a history of colectomy or extensive small bowel resection.
• •Subject with psychological or cognitive difficulties that might interfere with study participation.
• •Subject has any previous exposure to a Janus kinase inhibitor or medication with a similar mode of action (e.g. tofacitinib, baricitinib, upadacitinib).
• •Female subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.