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

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

Detailed Description
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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.

Official Title
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Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: V565
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V565<br>V565 three times a day (TID) PO for 6 weeks | Drug: V565<br>* Daily dosing of V565 three times a day orally for 6 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo TID PO for 6 weeks | Drug: Placebo<br>* Daily dosing of placebo three times a day orally for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42. | Number of responders at Day 42, defined as subjects achieving both CDAI ≥ 70-point reduction from baseline or CDAI score < 150, and a reduction of ≥ 40% from the baseline value of CRP or FCP. Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42. | Number of subjects achieving a ≥ 100-point reduction in CDAI score and a concomitant reduction of at least 50% in CRP or FCP at Day 42 Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. | Day 42 |