A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- 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
- 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)
Klinikum Wels Grieskirchen
🇦🇹Wels, Austria
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Specjalistyczna Praktyka
🇵🇱Sopot, Poland
Lviv Regional Clinical Hospital
🇺🇦L'viv, Ukraine
CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Med Inst
🇺🇦Sumy, Ukraine
CI of SRC Sumy RCH Dept of Gastroenterology Sumy SU MI
🇺🇦Sumy, Ukraine
Endomedix Diagnosztikai
🇭🇺Budapest, Hungary
Clinical Center Zemun
🇷🇸Belgrade, Serbia
Svet zdravia a.s.
🇸🇰Rimavská Sobota, Slovakia
Clinical Health Center Zvezdara
🇷🇸Belgrade, Serbia
CI of Kyiv RC Kyiv Regional Clinical Hospital
🇺🇦Kyiv, Ukraine
Brovary Central District Hospital
🇺🇦Brovary, Ukraine
Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC
🇺🇦Lviv, Ukraine
LLC Treatment and Diagnostic Center Adonis Plus
🇺🇦Kyiv, Ukraine
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
West Central Gastroenterology
🇺🇸Clearwater, Florida, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Klinikum Klagenfurt am Wörtersee
🇦🇹Klagenfurt, Austria
LKH - Universitatsklinikum
🇦🇹Salzburg, Austria
Praxiszentrum Alte Maelzerei
🇩🇪Regensburg, Bayern, Germany
LHSC - Victoria Hospital
🇨🇦London, Ontario, Canada
Poliklinika MEDICINA PLUS
🇨🇿Praha 4, Czechia
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
🇩🇪Berlin, Germany
Klinik u Poliklinik f Gastro
🇩🇪Leipzig, Germany
Staedisches Klinikum
🇩🇪Brandenburg, Germany
DRC Gyogyszervizsgalo
🇭🇺Balatonfüred, Hungary
Obudai Egeszsegugyi
🇭🇺Budapest, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
🇭🇺Budapest, Hungary
Akershus universitetssykehus HF
🇳🇴Lørenskog, Norway
Petz Aladar Hospital
🇭🇺Győr, Hungary
Polimedica Centrum Badan, Profilaktyki I Leczenia
🇵🇱Kielce, Poland
Universitetssykehuset Nord-Norge
🇳🇴Tromsø, Norway
Clinfan Szolgaltato Kft.
🇭🇺Szekszard, Hungary
Gabinet Lekarski Bartosz Korczowski
🇵🇱Rzeszów, Poland
Military Medical Academy
🇷🇸Belgrade, Serbia
Albert Schweitzer Ziekenhuis
🇳🇱Dordrecht, Netherlands
KO-MED Centra Kliniczne Lublin II
🇵🇱Lublin, Poland
SOLUMED Centrum Medyczne
🇵🇱Poznań, Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
🇵🇱Warszawa, Poland
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
KO-MED Centra Kliniczne Staszow
🇵🇱Staszów, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Clinical Center Nis
🇷🇸Niš, Serbia
Alian s.r.o
🇸🇰Bardejov, Slovakia
Uni nemocnica Bratislava
🇸🇰Bratislava, Slovakia
Nemocnica A.Lena Humenne, n.o
🇸🇰Humenné, Slovakia
Nemocnica s poliklinikou S. Kukuru Michalovce, a.s
🇸🇰Michalovce, Slovakia
KM Management spol. s r.o.
🇸🇰Nitra, Slovakia
Gastromedic, s.r.o
🇸🇰Nové Zámky, Slovakia
Gastro I, s.r.o.
🇸🇰Prešov, Slovakia
CHI Kharkiv City Clinical Hospital #13
🇺🇦Kharkiv, Ukraine
Limited Liability Company Medical Center Family Medicine Clinic
🇺🇦Dnipro, Ukraine
Hospital for War Veterans
🇺🇦Kharkiv, Ukraine
CI Ye.Ye.Karabelesh Kherson City Clinical Hosp
🇺🇦Kherson, Ukraine
Medical Centre CONSILIUM MEDICAL
🇺🇦Kyiv, Ukraine
Municipal Institution of Public Health Kharkiv City Clinic #9
🇺🇦Kharkiv, Ukraine
CI of Healthcare Kharkiv Reg Clin Hospital
🇺🇦Kharkiv, Ukraine
PPC Atsynus
🇺🇦Kirovohrad, Ukraine
Royal Hallamshire Hospital
🇬🇧Sheffield, South Yorkshire, United Kingdom
Medical Center Pulse
🇺🇦Vinnytsia, Ukraine
Private Small Enterprise Medical Center Pulse
🇺🇦Vinnytsia, Ukraine
Vinnytsia M.I.Pyrogov Regional Clinical Hospital
🇺🇦Vinnytsia, Ukraine
CI City Clinical Hospital #6
🇺🇦Zaporizhzhia, Ukraine
John Radcliffe Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom
Whipps Cross University Hospital
🇬🇧Leytonstone, London, United Kingdom
CI City Hospital #1
🇺🇦Zaporizhzhia, Ukraine
Addenbrookes Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom
St Mark's Hospital
🇬🇧Harrow, Middlesex, United Kingdom
Neath Port Talbot Hospital
🇬🇧Swansea, West Glamorgan, United Kingdom
Klinikum der Johann Wolfgang Goethe-Universitaet
🇩🇪Frankfurt, Hessen, Germany
Universitaetsklinikum Carl Gustav Carus TU
🇩🇪Dresden, Sachsen, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
🇩🇪Kiel, Schleswig, Germany
Charite Universitaetsmedizin
🇩🇪Berlin, Germany
Hamburgisches Forschungsinstitut fuer CED
🇩🇪Hamburg, Germany
Praxis fuer Magen
🇩🇪Heidelberg, Germany
Asklepios Klinik Hamburg
🇩🇪Hamburg, Germany
Clinical Trials of America
🇺🇸Mount Airy, North Carolina, United States
AKH - Medizinische Universität Wien
🇦🇹Vienna, Austria
Galiz Research, LLC
🇺🇸Miami Springs, Florida, United States
Nemocnice Horovice
🇨🇿Horovice, Czechia
London Health Science Centre
🇨🇦London, Ontario, Canada
Vojenska nemocnice Brno
🇨🇿Brno, Czechia
Mediendo s.r.o.
🇨🇿Praha 8, Czechia
Hepato-Gastroenterologie HK
🇨🇿Hradec Kralove, Czechia
Agaplesion Markus Krankenhaus
🇩🇪Frankfurt, Germany
EUGASTRO GmbH
🇩🇪Leipzig, Germany
Studiengesellschaft BSF
🇩🇪Halle, Germany
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Indywidualna Specjalistyczna
🇵🇱Knurów, Poland
Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU
🇺🇦Chernivtsi, Ukraine
Queen Elizabeth University Hospital
🇬🇧Glasgow, Strathclyde, United Kingdom
St Thomas' Hospital
🇬🇧London, United Kingdom
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada