Open-label V565 Target Engagement Study
Open-label V565 Target Engagement Study
The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and
 reduces inflammation after oral dosing to patients with IBD.
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.