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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02976129
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : February 12, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: V565 Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's Disease
Study Start Date : December 2016
Estimated Primary Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
Experimental: V565
V565 TID PO for 6 weeks
Drug: V565
Daily dosing of V565 three times a day orally for 6 weeks
Placebo Comparator: Placebo
Placebo TID PO for 6 weeks
Drug: Placebo
Daily dosing of placebo three times a day orally for 6 weeks

Primary Outcome Measures :
  1. CDAI and Inflammatory Markers [ Time Frame: Day 42 ]
    Proportion of responders at Day 42

Secondary Outcome Measures :
  1. Change from baseline in PRO-2 [ Time Frame: Day 42 ]

Other Outcome Measures:
  1. Changes in endoscopic appearance [ Time Frame: Day 42 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • History of Crohn's Disease of at least 3 months duration prior to screening
  • CDAI score of ≥220 to ≤450 during screening
  • CRP ≥5 mg/L (or, if CRP is normal, 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-TNFα agent
  • Certain complications of Crohn's Disease that would make it hard to assess response to study drug
  • Known history or suspicion of IBD other than Crohn's disease
  • History of 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02976129

Contact: VHsquared Information +44 (0)1223 837650

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Sponsors and Collaborators
VHsquared Ltd.
Study Director: Suhail Nurbhai, MBChB MRCP VHsquared Ltd.

Responsible Party: VHsquared Ltd. Identifier: NCT02976129     History of Changes
Other Study ID Numbers: V56502
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases