About The Study
Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) characterized by diffuse, continuous inflammation of the colon. This disease affects people of all ages and recent estimates suggest that approximately 17,000 children between 5 and 17 years of age in the United States (US) are diagnosed with UC.
Ulcerative Colitis study is the treatment of mildly to moderately active ulcerative colitis (UC) in patients 5 years of age and older, and for the maintenance of remission of UC in pediatric subjects aged 5 to 17 years
Eligibility Criteria
- Pediatric male or female subject, ages 5 to 17 years at the time of the first dose of study drug.
- Diagnosis of Ulcerative Colitis (UC).
- No abnormal and clinically significant results according to the investigator or designee, on physical examination, medical history, ECG, hematology, clinical chemistry, or urinalysis.
- Bodyweight no less than 17 kg (37.5 lbs.) and no more than 90 kg (198lbs).
