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

Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active 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).

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: V565; Drug: Placebo

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
• Enrollment (Actual): 125
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt am Wörtersee
  • Salzburg, Austria, 5020
    • LKH - Universitätsklinikum
  • Vienna, Austria, 1090
    • AKH - Medizinische Universitat Wien
  • Wels, Austria, 4600
    • Klinikum Wels Grieskirchen
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • LHSC - Victoria Hospital
    • London, Ontario, Canada, N6A 5A5
      • London Health Science Centre
• Czechia
  • Brno, Czechia, 636 00
    • Vojenska nemocnice Brno
  • Horovice, Czechia
    • Nemocnice Horovice
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterologie HK
  • Praha 4, Czechia, 14000
    • Poliklinika MEDICINA PLUS
  • Praha 8, Czechia, 186 00
    • MEDIENDO s.r.o.
• Germany
  • Berlin, Germany, 13353
    • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  • Berlin, Germany, 12203
    • Charite Universitaetsmedizin
  • Brandenburg, Germany, 14770
    • Staedisches Klinikum
  • Frankfurt, Germany, 60431
    • Agaplesion Markus Krankenhaus
  • Halle, Germany, 06108
    • Studiengesellschaft BSF
  • Hamburg, Germany, 22559
    • Asklepios Klinik Hamburg
  • Hamburg, Germany, 20251
    • Hamburgisches Forschungsinstitut fuer CED
  • Heidelberg, Germany, 69121
    • Praxis fuer Magen
  • Leipzig, Germany, 04103
    • Eugastro GmbH
  • Leipzig, Germany, 04103
    • Klinik u Poliklinik f Gastro
  • Bayern
    • Regensburg, Bayern, Germany, 93053
      • Praxiszentrum Alte Maelzerei
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Klinikum Der Johann Wolfgang Goethe-Universitaet
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus TU
  • Schleswig
    • Kiel, Schleswig, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
• Hungary
  • Balatonfüred, Hungary, 8230
    • DRC Gyogyszervizsgalo
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Egeszsegugyi Kozpont
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi
  • Budapest, Hungary, 1139
    • Endomedix Diagnosztikai
  • Győr, Hungary, 9024
    • Petz Aladar Hospital
  • Szekszard, Hungary, 7100
    • Clinfan Szolgaltato Kft.
• Netherlands
  • Dordrecht, Netherlands, 3318AT
    • Albert Schweitzer Ziekenhuis
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
• Norway
  • Lørenskog, Norway, 1478
    • Akershus Universitetssykehus HF
  • Tromsø, Norway, 9019
    • Universitetssykehuset Nord-Norge
• Poland
  • Kielce, Poland, 25-364
    • Polimedica Centrum Badań, Profilaktyki I Leczenia
  • Knurów, Poland, 44-190
    • Indywidualna Specjalistyczna
  • Lublin, Poland, 20-362
    • KO-MED Centra Kliniczne Lublin II
  • Poznań, Poland, 60-529
    • SOLUMED Centrum Medyczne
  • Rzeszów, Poland, 35-302
    • Gabinet Lekarski Bartosz Korczowski
  • Sopot, Poland, 81-756
    • Specjalistyczna Praktyka
  • Staszów, Poland, 28-200
    • KO-MED Centra Kliniczne Staszow
  • Szczecin, Poland, 71-270
    • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Warszawa, Poland, 00-632
    • Centrum Zdrowia Matki, Dziecka i Mlodziezy
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11080
    • Clinical Center Zemun
  • Belgrade, Serbia, 11000
    • Clinical Health Center Zvezdara
  • Niš, Serbia, 18000
    • Clinical Center Nis
• Slovakia
  • Bardejov, Slovakia, 08501
    • Alian s.r.o
  • Bratislava, Slovakia, 82606
    • Uni nemocnica Bratislava
  • Humenné, Slovakia, 06601
    • Nemocnica A.Lena Humenne, n.o
  • Michalovce, Slovakia, 07101
    • Nemocnica s poliklinikou S. Kukuru Michalovce, a.s
  • Nitra, Slovakia, 949 01
    • KM Management spol. s r.o.
  • Nové Zámky, Slovakia, 94002
    • Gastromedic, s.r.o
  • Prešov, Slovakia, 080 01
    • Gastro I, s.r.o.
  • Rimavská Sobota, Slovakia, 97901
    • Svet zdravia a.s.
• Ukraine
  • Brovary, Ukraine, 07400
    • Brovary Central District Hospital
  • Chernivtsi, Ukraine, 58001
    • Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU
  • Dnipro, Ukraine, 49038
    • Limited Liability Company Medical Center Family Medicine Clinic
  • Kharkiv, Ukraine, 61124
    • CHI Kharkiv City Clinical Hospital #13
  • Kharkiv, Ukraine, 61019
    • Hospital for War Veterans
  • Kharkiv, Ukraine, 61172
    • Municipal Institution of Public Health Kharkiv City Clinic #9
  • Kharkiv, Ukraine, 61204
    • CI of Healthcare Kharkiv Reg Clin Hospital
  • Kherson, Ukraine, 73000
    • CI Ye.Ye.Karabelesh Kherson City Clinical Hosp
  • Kirovohrad, Ukraine, 25006
    • PPC Atsynus
  • Kyiv, Ukraine, 02002
    • LLC Treatment and Diagnostic Center Adonis Plus
  • Kyiv, Ukraine, 04107
    • CI of Kyiv RC Kyiv Regional Clinical Hospital
  • Kyiv, Ukraine, 4050
    • Medical Centre CONSILIUM Medical
  • L'viv, Ukraine, 79010
    • Lviv Regional Clinical Hospital
  • Lviv, Ukraine, 79007
    • Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC
  • Sumy, Ukraine, 40021
    • CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Med Inst
  • Sumy, Ukraine, 40022
    • CI of SRC Sumy RCH Dept of Gastroenterology Sumy SU MI
  • Vinnytsia, Ukraine, 21001
    • Private Small Enterprise Medical Center Pulse
  • Vinnytsia, Ukraine, 21018
    • Vinnytsia M.I.Pyrogov Regional Clinical Hospital
  • Vinnytsia, Ukraine, 21001
    • Medical Center Pulse
  • Zaporizhzhia, Ukraine, 69104
    • CI City Hospital #1
  • Zaporizhzhia, Ukraine, 69035
    • CI City Clinical Hospital #6
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • St Thomas' Hospital
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Addenbrookes Hospital
  • London
    • Leytonstone, London, United Kingdom, E11 1NR
      • Whipps Cross University Hospital
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • St Mark's Hospital
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • John Radcliffe Hospital
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Royal Hallamshire Hospital
  • Strathclyde
    • Glasgow, Strathclyde, United Kingdom, G51 4TF
      • Queen Elizabeth University Hospital
  • West Glamorgan
    • Swansea, West Glamorgan, United Kingdom, SA12 7BX
      • Neath Port Talbot Hospital
• United States
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc.
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • Clearwater, Florida, United States, 33762
      • West Central Gastroenterology
    • Miami Springs, Florida, United States, 33166
      • Galiz Research, LLC
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • North Carolina
    • Mount Airy, North Carolina, United States, 27030
      • Clinical Trials of America

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V565; V565 three times a day (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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Improvement in Endoscopic Mucosal Appearance	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.	Day 42
Number of Subjects Achieving CRP Levels Within Normal Limits at 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	Days 14 and 42
Number of Subjects Achieving FCP Levels Within Normal Limits at Day 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	Days 14 and 42

Collaborators and Investigators

• Sponsor: VHsquared Ltd.
• Investigators: Study Director: Suhail Nurbhai, MBChB MRCP, VHsquared Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): March 8, 2019
• Study Completion (Actual): March 8, 2019

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: V56502