Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
VHsquared Ltd.
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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Open-label V565 Target Engagement Study
