A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease (HarbOR)

VHsquared

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: V565; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02976129

V56502

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease (CD).

Full description

This study will be a multiple-site, double-blind, placebo-controlled, parallel-group study in approximately 126 subjects with a confirmed diagnosis of CD for at least three months and have CD involving the ileum and/or colon. Following a screening period of up to 28 days, subjects will be randomly allocated into one of two treatment arms: either V565 or placebo using a 2:1 active:placebo ratio for a treatment period of 6 weeks.

Subjects will be treated with study drug as an add-on to any permitted stable medications already being taken for CD.

Enrollment: 125 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of Crohn's Disease of at least 3 months duration prior to screening
• Crohn's Disease Activity Index (CDAI) score of ≥220 to ≤450 during screening
• C-reactive protein (CRP) ≥5 mg/L (or, if CRP is normal, faecal calprotectin (FCP) ≥250 µg/g) at screening
• Permitted CD medication regimen expected to remain stable during the period of the study

Exclusion criteria

• Previous lack of response or current contra-indication to an anti-tumour necrosis factor α (anti-TNFα) agent
• Certain complications of Crohn's Disease that would make it hard to assess response to study drug
• Known history or suspicion of inflammatory bowel disease other than Crohn's disease
• History of tuberculosis (TB) or latent TB infection that has not been treated
• Any significant illness or condition which would preclude effective participation in the study
• GI infection as demonstrated by presence of enteric pathogens
• Pregnant or lactating women
• Abdominal surgery in the previous 6 months
• Unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 2 patient groups, including a placebo group

V565

Experimental group

Description:

V565 three times a day (TID) PO for 6 weeks

Treatment:

Drug: V565

Placebo

Placebo Comparator group

Description:

Placebo TID PO for 6 weeks

Treatment:

Drug: Placebo