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

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: Placebo; Drug: V565

• Registration Number: NCT02976129
• Lead Sponsor: VHsquared Ltd.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Study Start: 2016-12
• Primary Completion: 2019-03-08
• Study Completion: 2019-03-08
• Results First Submitted: 2021-10-15
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-24
• Last Update Submitted: 2021-11-24
• Results First Posted: 2021-12-22
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo TID PO for 6 weeks
V565	V565	V565 three times a day (TID) PO for 6 weeks

Primary Outcome Measures

Name	Time	Method
Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.	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.

Trial Locations

Locations (94)

Advanced Research Center, Inc.; 🇺🇸 Anaheim, California, United States

West Central Gastroenterology; 🇺🇸 Clearwater, Florida, United States

Clinical Research of West Florida; 🇺🇸 Clearwater, Florida, United States

Galiz Research, LLC; 🇺🇸 Miami Springs, Florida, United States

Northwestern University; 🇺🇸 Evanston, Illinois, United States

Clinical Trials of America; 🇺🇸 Mount Airy, North Carolina, United States

Klinikum Klagenfurt am Wörtersee; 🇦🇹 Klagenfurt, Austria

LKH - Universitatsklinikum; 🇦🇹 Salzburg, Austria

AKH - Medizinische Universität Wien; 🇦🇹 Vienna, Austria

Klinikum Wels Grieskirchen; 🇦🇹 Wels, Austria

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