Open-label V565 Target Engagement Study
An Open-label Exploratory Study in Patient Volunteers With Ulcerative Colitis (UC), to Investigate Lamina Propria Presence and Evidence of Biological Effect of the Oral Domain Antibody V565
1 other identifier
interventional
5
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2017
CompletedFirst Submitted
Initial submission to the registry
October 9, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedOctober 15, 2018
October 1, 2018
5 months
October 9, 2018
October 12, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Reduction of phosphorylation in mucosal biopsies
After 7 days oral treatment
Presence of drug in mucosal biopsies
After 7 days oral treatment
Study Arms (1)
V565
EXPERIMENTALV565 orally three times daily for up to 7 days
Interventions
Eligibility Criteria
You may qualify 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 qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VHsquared Ltd.lead
Study Sites (1)
The Royal London Hospital
London, E1 1BB, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Suhail Nurbhai, MBChB
VHsquared Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2018
First Posted
October 15, 2018
Study Start
May 23, 2017
Primary Completion
October 24, 2017
Study Completion
October 24, 2017
Last Updated
October 15, 2018
Record last verified: 2018-10