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

NCT ID: NCT02976129

Last Updated: 2021-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-03-08

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

V565

V565 three times a day (TID) PO for 6 weeks

Group Type: EXPERIMENTAL

V565

Intervention Type: DRUG

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

Placebo

Placebo TID PO for 6 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

V565

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VHsquared Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suhail Nurbhai, MBChB MRCP

Role: STUDY_DIRECTOR

VHsquared Ltd.

Locations

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

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

London Health Science Centre

London, Ontario, Canada

LHSC - Victoria Hospital

London, Ontario, Canada

Vojenska nemocnice Brno

Brno, , Czechia

Nemocnice Horovice

Hořovice, , Czechia

Hepato-Gastroenterologie HK

Hradec Králové, , Czechia

Poliklinika MEDICINA PLUS

Prague, , Czechia

Mediendo s.r.o.

Prague, , Czechia

Praxiszentrum Alte Maelzerei

Regensburg, Bavaria, Germany

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, Hesse, Germany

Universitaetsklinikum Carl Gustav Carus TU

Dresden, Saxony, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig, Germany

Charite Universitaetsmedizin

Berlin, , Germany

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, , Germany

Staedisches Klinikum

Brandenburg, , Germany

Agaplesion Markus Krankenhaus

Frankfurt, , Germany

Studiengesellschaft BSF

Halle, , Germany

Hamburgisches Forschungsinstitut fuer CED

Hamburg, , Germany

Asklepios Klinik Hamburg

Hamburg, , Germany

Praxis fuer Magen

Heidelberg, , Germany

EUGASTRO GmbH

Leipzig, , Germany

Klinik u Poliklinik f Gastro

Leipzig, , Germany

DRC Gyogyszervizsgalo

Balatonfüred, , Hungary

Obudai Egeszsegugyi

Budapest, , Hungary

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Endomedix Diagnosztikai

Budapest, , Hungary

Petz Aladar Hospital

Győr, , Hungary

Clinfan Szolgaltato Kft.

Szekszárd, , Hungary

Albert Schweitzer Ziekenhuis

Dordrecht, , Netherlands

Maastricht University Medical Center

Maastricht, , Netherlands

Akershus universitetssykehus HF

Lørenskog, , Norway

Universitetssykehuset Nord-Norge

Tromsø, , Norway

Polimedica Centrum Badan, Profilaktyki I Leczenia

Kielce, , Poland

Indywidualna Specjalistyczna

Knurów, , Poland

KO-MED Centra Kliniczne Lublin II

Lublin, , Poland

SOLUMED Centrum Medyczne

Poznan, , Poland

Gabinet Lekarski Bartosz Korczowski

Rzeszów, , Poland

Specjalistyczna Praktyka

Sopot, , Poland

KO-MED Centra Kliniczne Staszow

Staszów, , Poland

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, , Poland

Centrum Zdrowia Matki, Dziecka i Mlodziezy

Warsaw, , Poland

Clinical Center of Serbia

Belgrade, , Serbia

Clinical Health Center Zvezdara

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Clinical Center Zemun

Belgrade, , Serbia

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

Svet zdravia a.s.

Rimavská Sobota, , Slovakia

Brovary Central District Hospital

Brovary, , Ukraine

Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU

Chernivtsi, , Ukraine

Limited Liability Company Medical Center Family Medicine Clinic

Dnipro, , Ukraine

Hospital for War Veterans

Kharkiv, , Ukraine

CHI Kharkiv City Clinical Hospital #13

Kharkiv, , Ukraine

Municipal Institution of Public Health Kharkiv City Clinic #9

Kharkiv, , Ukraine

CI of Healthcare Kharkiv Reg Clin Hospital

Kharkiv, , Ukraine

CI Ye.Ye.Karabelesh Kherson City Clinical Hosp

Kherson, , Ukraine

PPC Atsynus

Kirovohrad, , Ukraine

LLC Treatment and Diagnostic Center Adonis Plus

Kyiv, , Ukraine

CI of Kyiv RC Kyiv Regional Clinical Hospital

Kyiv, , Ukraine

Medical Centre CONSILIUM MEDICAL

Kyiv, , Ukraine

Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC

Lviv, , Ukraine

Lviv Regional Clinical Hospital

Lviv, , 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

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

CI City Hospital #1

Zaporizhzhia, , Ukraine

Addenbrookes Hospital

Cambridge, Cambridgeshire, United Kingdom

Whipps Cross University Hospital

Leytonstone, London, United Kingdom

St Mark's Hospital

Harrow, Middlesex, United Kingdom

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom

Queen Elizabeth University Hospital

Glasgow, Strathclyde, United Kingdom

Neath Port Talbot Hospital

Swansea, West Glamorgan, United Kingdom

St Thomas' Hospital

London, , United Kingdom

Countries

United States; Austria; Canada; Czechia; Germany; Hungary; Netherlands; Norway; Poland; Serbia; Slovakia; Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

V56502

Identifier Type: -

Identifier Source: org_study_id