Inclusion Criteria:
- Aged 18 to 75 years (at screening for Cohorts 1 and 2)
- Male of Female adolescent patients aged 12 to < 18 years (at screening) with a body
weight > or = 45kg (Cohort 3)
- Ulcerative colitis confirmed on endoscopy
- Moderately to severely active ulcerative colitis (Mayo score 6-12)
- Currently receiving treatment with aminosalicylates, prednisone or budesonide
- Can be receiving azathioprine, mercaptopurine, or methotrexate but treatment will be
stopped prior to randomization
Exclusion Criteria:
- Have severe extensive colitis as evidenced by:
- Physician judgement that the patient is likely to require colectomy or ileostomy
within 12 weeks of baseline
- Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or
bowel perforation
- Diagnosis of Crohn's disease, indeterminate colitis, or the presence of a fistula
consistent with Crohn's disease or microscopic colitis, radiation colitis, or ischemic
colitis
- Clinically relevant cardiovascular conditions or other relevant diseases that could
impact the implementation or interpretation of the trial, or put the patient at risk
- History of uveitis or known macular edema
- Pregnancy, lactation, or a positive serum B-hCG measured during screening
Recruiting
