Open-label V565 Target Engagement Study

VHsquared

Status and phase

Completed

Phase 1

Conditions

Ulcerative Colitis

Treatments

Biological: V565

Study type

Interventional

Funder types

Industry

Identifiers

NCT03705117

V56503

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.