V56502: Efficacy, safety, & tolerability of V565 treatment
Research type
Research Study
Full title
A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease
IRAS ID
220276
Contact name
Simon Piers Leigh Travis
Contact email
Sponsor organisation
VHsquared Ltd.
Eudract number
2016-002939-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 24 days
Research summary
The main purpose of the study is to look at how well a new potential treatment, V565, works to improve symptoms and inflammation associated with Crohn’s Disease (CD) when added to a patients regular treatment for CD. The study will compare differences between patients receiving V565 compared to those receiving placebo to see how effective and safe it is, and how it is processed by the body (also known as pharmacokinetics). Approximately 126 subjects in about 76 study centres in North America and Europe will take part in this study. Two thirds of patients will receive V565 and one third will receive placebo. The study is ‘double-blinded’; neither the patient nor the study doctor will know whether the patient is receiving placebo or active drug. Participants will be in the study for up to 12 weeks, during this time they will attend up to six visits to the study centre.
This is a Phase 2 study, which means V565 has already been studied in animals and in healthy volunteers. V565 must be studied in people with CD to learn how safe and effective it is before it can be approved as a prescription drug. V565 is a type of antibody thought to work by blocking a protein in the body, called tumour necrosis factor-alpha (TNF-α). There are already proven treatments for Crohn’s disease that target the same protein but they are all given by injection. V565 is given as capsules taken by mouth, and has been developed to work directly in the gut.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
17/SC/0023
Date of REC Opinion
19 Jan 2017
REC opinion
Favourable Opinion