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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03705117

Enrollment

Registered

2018-10-15

Start date

2017-05-23

Completion date

2017-10-24

Last updated

2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

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.

Detailed description

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.

Interventions

BIOLOGICALV565

Capsules for oral administration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Reduction of phosphorylation in mucosal biopsies	After 7 days oral treatment
Presence of drug in mucosal biopsies	After 7 days oral treatment

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026