Open-label V565 Target Engagement Study

Phase 1

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT03705117
• Lead Sponsor: VHsquared Ltd.

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.

Study Timeline

• Study Start: 2017-05-23
• Primary Completion: 2017-10-24
• Study Completion: 2017-10-24
• Status Verified: 2018-10
• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-12
• Last Update Submitted: 2018-10-12
• Study First Posted: 2018-10-15
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction of phosphorylation in mucosal biopsies	After 7 days oral treatment
Presence of drug in mucosal biopsies	After 7 days oral treatment

Trial Locations

Locations (1)

The Royal London Hospital; 🇬🇧 London, United Kingdom