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

Inclusion Criteria:

• Subject must have a minimum body weight (BW) of 15 kg.

• Subject:

• has documented diagnosis of UC with a minimum duration of 3 months,

• has mMCS of 5 to 9, and an MCS endoscopic score >=2, rectal bleeding >=1, andstool frequency >=1,

• has had an inadequate response, loss of response, intolerance, or has medicalcontraindications to corticosteroids, immunosuppressants, and/or biologictherapy. This includes subjects who depend on corticosteroids to control theirsymptoms and who experience worsening of their disease when attempting to weanoff corticosteroids.

Exclusion Criteria:

• Subject has a diagnosis of inflammatory bowel disease -unclassified or indeterminatecolitis, isolated proctitis, or toxic megacolon.

• Subject has an active infection.

• Subject with a history of complicated herpes zoster infection (withmulti-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 studyparticipation.

• Subject has any previous exposure to a Janus kinase inhibitor or medication with asimilar mode of action (e.g. tofacitinib, baricitinib, upadacitinib).

• Female subject is pregnant or breast feeding or intending to become pregnant orbreastfeed during the study.