Open-label V565 Target Engagement Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-23

Study Completion Date

2017-10-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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V565

V565 orally three times daily for up to 7 days

Group Type EXPERIMENTAL

V565

Intervention Type BIOLOGICAL

Capsules for oral administration

Interventions

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V565

Capsules for oral administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No