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Open-label V565 Target Engagement Study

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

V565

About this trial

This is an interventional basic science trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

The Royal London Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

V565

Arm Description

V565 orally three times daily for up to 7 days

Outcomes

Primary Outcome Measures

Reduction of phosphorylation in mucosal biopsies

Presence of drug in mucosal biopsies

Secondary Outcome Measures

Full Information

NCT ID

NCT03705117

First Posted

October 9, 2018

Last Updated

October 12, 2018

Sponsor

VHsquared Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03705117

Brief Title

Open-label V565 Target Engagement Study

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

May 23, 2017 (Actual)

Primary Completion Date

October 24, 2017 (Actual)

Study Completion Date

October 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VHsquared Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

V565

Arm Type

Experimental

Arm Description

V565 orally three times daily for up to 7 days

Intervention Type

Biological

Intervention Name(s)

V565

Intervention Description

Capsules for oral administration

Primary Outcome Measure Information:

Title

Reduction of phosphorylation in mucosal biopsies

Time Frame

After 7 days oral treatment

Title

Presence of drug in mucosal biopsies

Time Frame

After 7 days oral treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suhail Nurbhai, MBChB

Organizational Affiliation

VHsquared Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

The Royal London Hospital

City

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Open-label V565 Target Engagement Study

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