Ulcerative Colitis Clinical Trial
Official title:
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
Verified date | October 2018 |
Source | VHsquared Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | October 24, 2017 |
Est. primary completion date | October 24, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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-TNFa 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 TNFa inhibitor - Contraindication to TNFa 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Royal London Hospital | London |
Lead Sponsor | Collaborator |
---|---|
VHsquared Ltd. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of phosphorylation in mucosal biopsies | After 7 days oral treatment | ||
Primary | Presence of drug in mucosal biopsies | After 7 days oral treatment |
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