Phase
Condition
Ulcerative Colitis
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion:
• Male or Female, 18 to 75 years old
• Subject must be on a stable dose (5-10 mg/kg) of Remicade, Inflectra, or Remsima - for a minimum of 14 weeks and a maximum of 2 years
• Documented diagnosis of UC for at least 4 months, and with a minimum disease extent of at least 25 cm from the anal verge
• Subject must still have ACTIVE UC, and NOT be considered in remission, while on Remicade
• May be on the following meds: 5-ASA compounds (stable for 4 weeks prior to randomization), Corticosteroids (stable for 2 weeks prior to randomization), Azathioprine / 6-MP / MTX (stable for 8 weeks prior to randomization)
Exclusion:
• Subjects with known colonic stricture, or history of colonic or small bowel obstruction or resection, or total colectomy
• Subjects with pouchitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, or Crohn's disease
• Subjects who require Remicade dosing interval other than every 8 weeks
• Subjects with primary sclerosing cholangitis
• Subjects with significant cardiac issues: MI or unstable angina (within 24 weeks before Screening), current or history of QT prolongation, and Class III / IV heart failure
• History of malignancy within the last 5 years (other than resected cutaneous basal cell or squamous cell carcinoma)