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Completed

NCT Number: NCT02976129

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

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

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Klinikum Klagenfurt am Wörtersee, Klagenfurt, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V565

Drug

Daily dosing of V565 three times a day orally for 6 weeks

Placebo

Drug

Daily dosing of placebo three times a day orally for 6 weeks

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Other outcomes

  1. Number of Subjects With Improvement in Endoscopic Mucosal Appearance

    Time frame: Day 42

    Subjects with a pre-treatment endoscopy Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 7 (4 if disease was confined to ileum) had a post-treatment endoscopy to evaluate changes in mucosal appearance. The central reader of the endoscopies, blinded to treatment and sequence, was asked to grade if video A was better or worse than video B. Pre- and post-treatment videos were randomly assigned to A and B. The endpoint is the number of subjects whose post-treatment endoscopy was better than their pre-treatment endoscopy.

  2. Number of Subjects Achieving CRP Levels Within Normal Limits at Days 14 and 42

    Time frame: Days 14 and 42

    The number of subjects who entered the study with an elevated CRP who had a CRP level within normal limits at Days 14 and 42.

    Normal levels defined as CRP less than or equal to 5mg/L

  3. Number of Subjects Achieving FCP Levels Within Normal Limits at Day 14 and 42

    Time frame: Days 14 and 42

    The number of subjects who entered the study with an elevated FCP who had an FCP level within normal limits at Days 14 and 42.

    Normal limits of FCP defined as less than or equal to 250µg/g

Sponsors and collaborators

Lead sponsor

VHsquared Ltd.

Industry

Registry information

Official study title

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

Acronym: HarbOR

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 29, 2016
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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