Open-label V565 Target Engagement Study

Single-site, open-label study in up to 6 patients treated for up to 7 days with sigmoidoscopy and biopsies before and after treatment period to determine biological activity.

Inclusion criteria

• Established diagnosis of UC for 12 months or more
• Distal disease, accessible by flexible sigmoidoscopy
• Mild to moderate UC as defined as Mayo score between 3 - 10 with Mayo endoscopic sub score ≥1

Exclusion criteria

• A known hypersensitivity to any of the inactive ingredients of the study treatment
• A diagnosis of any IBD except UC
• Isolated proctitis
• Stool culture positive for C. difficile or other enteric infection
• Untreated tuberculosis (TB); positive QuantiFERON-TB Gold Test result (performed by Central Laboratory)
• Evidence of previous or present hepatitis B or C infection
• Known severe viral infection within six weeks prior to Visit 1
• Current use of topical mesalazine or anti-infectives for serious infection (or within 1 week)
• Anti-TNFα therapy other than the study drug
• Parenteral or enteral nutrition therapy
• Current use of any biologic agent
• Primary failure or secondary loss of response (LOR) to use of a TNFα inhibitor
• Contraindication to TNFα inhibitor
• Clinically significant abnormal laboratory test result at screening
• Taken an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.