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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02976129
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

VHsquared Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Suhail Nurbhai, MBChB MRCP
Principal Investigator Affiliation VHsquared Ltd.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Austria, Canada, Czechia, Germany, Hungary, Netherlands, Norway, Poland, Serbia, Slovakia, Ukraine, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Del Sol Research Management, Tucson, Arizona

Status

Withdrawn

Address

Del Sol Research Management

Tucson, Arizona, 85710

Advanced Research Center, Inc., Anaheim, California

Status

Recruiting

Address

Advanced Research Center, Inc.

Anaheim, California, 92805

Precision Research Institute, LLC, San Diego, California

Status

Withdrawn

Address

Precision Research Institute, LLC

San Diego, California, 92114

West Central Gastroenterology, Clearwater, Florida

Status

Recruiting

Address

West Central Gastroenterology

Clearwater, Florida, 33762

Clinical Research of West Florida, Clearwater, Florida

Status

Recruiting

Address

Clinical Research of West Florida

Clearwater, Florida, 33765

Sarkis Clinical Trials, Gainesville, Florida

Status

Withdrawn

Address

Sarkis Clinical Trials

Gainesville, Florida, 32607

Galiz Research, LLC, Miami Springs, Florida

Status

Recruiting

Address

Galiz Research, LLC

Miami Springs, Florida, 33166

New Horizon Research Center, Inc, Miami, Florida

Status

Withdrawn

Address

New Horizon Research Center, Inc

Miami, Florida, 33175

Northwestern University, Evanston, Illinois

Status

Recruiting

Address

Northwestern University

Evanston, Illinois, 60208

Cotton-O'Neill Clinical Research Center, Topeka, Kansas

Status

Withdrawn

Address

Cotton-O'Neill Clinical Research Center

Topeka, Kansas, 66606

Via Christi Research, Wichita, Kansas

Status

Withdrawn

Address

Via Christi Research

Wichita, Kansas, 67208

Clinical Trials of America, Mount Airy, North Carolina

Status

Recruiting

Address

Clinical Trials of America

Mount Airy, North Carolina, 27030

Global Medical Research, DeSoto, Texas

Status

Withdrawn

Address

Global Medical Research

DeSoto, Texas, 75115

International Sites

Klinikum Klagenfurt am Wörtersee, Klagenfurt, Austria

Status

Recruiting

Address

Klinikum Klagenfurt am Wörtersee

Klagenfurt, , 9020

Ried im Innkreis, Austria

Status

Withdrawn

Address

Krankenhaus der Barmherzigen Schwestern Ried

Ried im Innkreis, , 4910

LKH - Universitatsklinikum, Salzburg, Austria

Status

Recruiting

Address

LKH - Universitatsklinikum

Salzburg, , 5020

St Veit An Der Glan, Austria

Status

Withdrawn

Address

KH der Barmherzigen Brüder St.Veit an der Glan

St Veit An Der Glan, , 9300

AKH - Medizinische Universität Wien, Vienna, Austria

Status

Recruiting

Address

AKH - Medizinische Universität Wien

Vienna, , 1090

Klinikum Wels Grieskirchen, Wels, Austria

Status

Recruiting

Address

Klinikum Wels Grieskirchen

Wels, , 4600

Halifax, Nova Scotia, Canada

Status

Recruiting

Address

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9

London Health Science Centre, London, Ontario, Canada

Status

Recruiting

Address

London Health Science Centre

London, Ontario, N6A 5A5

LHSC - Victoria Hospital, London, Ontario, Canada

Status

Recruiting

Address

LHSC - Victoria Hospital

London, Ontario, N6A 5W9

Humber River Hospital, Toronto, Ontario, Canada

Status

Withdrawn

Address

Humber River Hospital

Toronto, Ontario, M3M 0B2

Vojenska nemocnice Brno, Brno, Czechia

Status

Recruiting

Address

Vojenska nemocnice Brno

Brno, , 636 00

Nemocnice Horovice, Horovice, Czechia

Status

Recruiting

Address

Nemocnice Horovice

Horovice, ,

Hepato-Gastroenterologie HK, Hradec Kralove, Czechia

Status

Recruiting

Address

Hepato-Gastroenterologie HK

Hradec Kralove, , 500 12

Poliklinika MEDICINA PLUS, Praha 4, Czechia

Status

Recruiting

Address

Poliklinika MEDICINA PLUS

Praha 4, , 14000

Mediendo s.r.o., Praha 8, Czechia

Status

Recruiting

Address

Mediendo s.r.o.

Praha 8, , 186 00

Clintrial s.r.o, Praha, Czechia

Status

Withdrawn

Address

Clintrial s.r.o

Praha, , 100 00

Praxiszentrum Alte Maelzerei, Regensburg, Bayern, Germany

Status

Recruiting

Address

Praxiszentrum Alte Maelzerei

Regensburg, Bayern, 93053

Frankfurt, Hessen, Germany

Status

Recruiting

Address

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt, Hessen, 60590

Dresden, Sachsen, Germany

Status

Recruiting

Address

Universitaetsklinikum Carl Gustav Carus TU

Dresden, Sachsen, 01307

Kiel, Schleswig, Germany

Status

Recruiting

Address

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig, 24105

Charite Universitaetsmedizin, Berlin, Germany

Status

Recruiting

Address

Charite Universitaetsmedizin

Berlin, , 12203

Berlin, Germany

Status

Recruiting

Address

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, , 13353

Staedisches Klinikum, Brandenburg, Germany

Status

Recruiting

Address

Staedisches Klinikum

Brandenburg, , 14770

Agaplesion Markus Krankenhaus, Frankfurt, Germany

Status

Recruiting

Address

Agaplesion Markus Krankenhaus

Frankfurt, , 60431

Studiengesellschaft BSF, Halle, Germany

Status

Recruiting

Address

Studiengesellschaft BSF

Halle, , 06108

Hamburg, Germany

Status

Recruiting

Address

Hamburgisches Forschungsinstitut fuer CED

Hamburg, , 20251

Asklepios Klinik Hamburg, Hamburg, Germany

Status

Recruiting

Address

Asklepios Klinik Hamburg

Hamburg, , 22559

Praxis fuer Magen, Heidelberg, Germany

Status

Recruiting

Address

Praxis fuer Magen

Heidelberg, , 69121

EUGASTRO GmbH, Leipzig, Germany

Status

Recruiting

Address

EUGASTRO GmbH

Leipzig, , 04103

Klinik u Poliklinik f Gastro, Leipzig, Germany

Status

Recruiting

Address

Klinik u Poliklinik f Gastro

Leipzig, , 04103

DRC Gyogyszervizsgalo, Balatonfüred, Hungary

Status

Recruiting

Address

DRC Gyogyszervizsgalo

Balatonfüred, , 8230

Obudai Egeszsegugyi, Budapest, Hungary

Status

Recruiting

Address

Obudai Egeszsegugyi

Budapest, , 1036

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, Hungary

Status

Recruiting

Address

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, , 1062

Semmelweis Egyetem, Budapest, Hungary

Status

Recruiting

Address

Semmelweis Egyetem

Budapest, , 1088

Endomedix Diagnosztikai, Budapest, Hungary

Status

Recruiting

Address

Endomedix Diagnosztikai

Budapest, , 1139

Petz Aladar Hospital, Győr, Hungary

Status

Recruiting

Address

Petz Aladar Hospital

Győr, , 9024

Sopron, Hungary

Status

Withdrawn

Address

Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet

Sopron, , 9400

Szeged, Hungary

Status

Withdrawn

Address

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , 6720

Principal SMO Kft, Szeged, Hungary

Status

Withdrawn

Address

Principal SMO Kft

Szeged, , 6722

Clinfan Szolgaltato Kft., Szekszard, Hungary

Status

Recruiting

Address

Clinfan Szolgaltato Kft.

Szekszard, , 7100

Csongrad Megyei Dr. Bugyi Istvan Korhaz, Szentes, Hungary

Status

Withdrawn

Address

Csongrad Megyei Dr. Bugyi Istvan Korhaz

Szentes, , 6600

Albert Schweitzer Ziekenhuis, Dordrecht, Netherlands

Status

Recruiting

Address

Albert Schweitzer Ziekenhuis

Dordrecht, , 3318AT

Maastricht University Medical Center, Maastricht, Netherlands

Status

Recruiting

Address

Maastricht University Medical Center

Maastricht, , 6229 HX

ETZ Elisabeth, Tilburg, Netherlands

Status

Withdrawn

Address

ETZ Elisabeth

Tilburg, , 5022 GC

Akershus universitetssykehus HF, Lørenskog, Norway

Status

Recruiting

Address

Akershus universitetssykehus HF

Lørenskog, , 1478

Universitetssykehuset Nord-Norge, Tromsø, Norway

Status

Recruiting

Address

Universitetssykehuset Nord-Norge

Tromsø, , 9019

Kielce, Poland

Status

Recruiting

Address

Polimedica Centrum Badan, Profilaktyki I Leczenia

Kielce, , 25-364

Indywidualna Specjalistyczna, Knurów, Poland

Status

Recruiting

Address

Indywidualna Specjalistyczna

Knurów, , 44-190

KO-MED Centra Kliniczne Lublin II, Lublin, Poland

Status

Recruiting

Address

KO-MED Centra Kliniczne Lublin II

Lublin, , 20-362

SOLUMED Centrum Medyczne, Poznań, Poland

Status

Recruiting

Address

SOLUMED Centrum Medyczne

Poznań, , 60-529

Gabinet Lekarski Bartosz Korczowski, Rzeszów, Poland

Status

Recruiting

Address

Gabinet Lekarski Bartosz Korczowski

Rzeszów, , 35-302

Specjalistyczna Praktyka, Sopot, Poland

Status

Recruiting

Address

Specjalistyczna Praktyka

Sopot, , 81-756

KO-MED Centra Kliniczne Staszow, Staszów, Poland

Status

Recruiting

Address

KO-MED Centra Kliniczne Staszow

Staszów, , 28-200

Szczecin, Poland

Status

Recruiting

Address

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, , 71-270

Warszawa, Poland

Status

Recruiting

Address

Centrum Zdrowia Matki, Dziecka i Mlodziezy

Warszawa, , 00-632

Clinical Center of Serbia, Belgrade, Serbia

Status

Recruiting

Address

Clinical Center of Serbia

Belgrade, , 11000

Clinical Health Center Zvezdara, Belgrade, Serbia

Status

Recruiting

Address

Clinical Health Center Zvezdara

Belgrade, , 11000

Military Medical Academy, Belgrade, Serbia

Status

Recruiting

Address

Military Medical Academy

Belgrade, , 11000

Clinical Center Zemun, Belgrade, Serbia

Status

Recruiting

Address

Clinical Center Zemun

Belgrade, , 11080

Clinical Center Kragujevac, Kragujevac, Serbia

Status

Withdrawn

Address

Clinical Center Kragujevac

Kragujevac, , 34000

Clinical Center Nis, Niš, Serbia

Status

Recruiting

Address

Clinical Center Nis

Niš, , 18000

Alian s.r.o, Bardejov, Slovakia

Status

Recruiting

Address

Alian s.r.o

Bardejov, , 08501

Uni nemocnica Bratislava, Bratislava, Slovakia

Status

Recruiting

Address

Uni nemocnica Bratislava

Bratislava, , 82606

Dunajská Streda, Slovakia

Status

Withdrawn

Address

Nemocnica s poliklinikou Dunajska Streda, a.s.

Dunajská Streda, , 92901

Nemocnica A.Lena Humenne, n.o, Humenné, Slovakia

Status

Recruiting

Address

Nemocnica A.Lena Humenne, n.o

Humenné, , 06601

Michalovce, Slovakia

Status

Recruiting

Address

Nemocnica s poliklinikou S. Kukuru Michalovce, a.s

Michalovce, , 07101

KM Management spol. s r.o., Nitra, Slovakia

Status

Recruiting

Address

KM Management spol. s r.o.

Nitra, , 949 01

Gastromedic, s.r.o, Nové Zámky, Slovakia

Status

Recruiting

Address

Gastromedic, s.r.o

Nové Zámky, , 94002

Gastro I, s.r.o., Prešov, Slovakia

Status

Recruiting

Address

Gastro I, s.r.o.

Prešov, , 080 01

Svet zdravia a.s., Rimavská Sobota, Slovakia

Status

Recruiting

Address

Svet zdravia a.s.

Rimavská Sobota, , 97901

Brovary Central District Hospital, Brovary, Ukraine

Status

Recruiting

Address

Brovary Central District Hospital

Brovary, , 07400

Chernivtsi, Ukraine

Status

Recruiting

Address

Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU

Chernivtsi, , 58001

Dnipro, Ukraine

Status

Recruiting

Address

Limited Liability Company Medical Center Family Medicine Clinic

Dnipro, , 49038

Hospital for War Veterans, Kharkiv, Ukraine

Status

Recruiting

Address

Hospital for War Veterans

Kharkiv, , 61019

CHI Kharkiv City Clinical Hospital #13, Kharkiv, Ukraine

Status

Recruiting

Address

CHI Kharkiv City Clinical Hospital #13

Kharkiv, , 61124

Kharkiv, Ukraine

Status

Recruiting

Address

Municipal Institution of Public Health Kharkiv City Clinic #9

Kharkiv, , 61172

Kharkiv, Ukraine

Status

Recruiting

Address

CI of Healthcare Kharkiv Reg Clin Hospital

Kharkiv, , 61204

Kherson, Ukraine

Status

Recruiting

Address

CI Ye.Ye.Karabelesh Kherson City Clinical Hosp

Kherson, , 73000

PPC Atsynus, Kirovohrad, Ukraine

Status

Recruiting

Address

PPC Atsynus

Kirovohrad, , 25006

Kyiv, Ukraine

Status

Recruiting

Address

LLC Treatment and Diagnostic Center Adonis Plus

Kyiv, , 02002

Kyiv, Ukraine

Status

Recruiting

Address

CI of Kyiv RC Kyiv Regional Clinical Hospital

Kyiv, , 04107

Medical Centre CONSILIUM MEDICAL, Kyiv, Ukraine

Status

Recruiting

Address

Medical Centre CONSILIUM MEDICAL

Kyiv, , 4050

Lviv Regional Clinical Hospital, L'viv, Ukraine

Status

Recruiting

Address

Lviv Regional Clinical Hospital

L'viv, , 79010

Lviv, Ukraine

Status

Recruiting

Address

Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC

Lviv, , 79007

Sumy, Ukraine

Status

Recruiting

Address

CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Med Inst

Sumy, , 40021

Sumy, Ukraine

Status

Recruiting

Address

CI of SRC Sumy RCH Dept of Gastroenterology Sumy SU MI

Sumy, , 40022

Medical Center Pulse, Vinnytsia, Ukraine

Status

Recruiting

Address

Medical Center Pulse

Vinnytsia, , 21001

Vinnytsia, Ukraine

Status

Recruiting

Address

Private Small Enterprise Medical Center Pulse

Vinnytsia, , 21001

Vinnytsia, Ukraine

Status

Recruiting

Address

Vinnytsia M.I.Pyrogov Regional Clinical Hospital

Vinnytsia, , 21018

CI City Clinical Hospital #6, Zaporizhzhia, Ukraine

Status

Recruiting

Address

CI City Clinical Hospital #6

Zaporizhzhia, , 69035

CI City Hospital #1, Zaporizhzhia, Ukraine

Status

Recruiting

Address

CI City Hospital #1

Zaporizhzhia, , 69104

Addenbrookes Hospital, Cambridge, Cambridgeshire, United Kingdom

Status

Recruiting

Address

Addenbrookes Hospital

Cambridge, Cambridgeshire, CB2 0QQ

Whipps Cross University Hospital, Leytonstone, London, United Kingdom

Status

Recruiting

Address

Whipps Cross University Hospital

Leytonstone, London, E11 1NR

St Mark's Hospital, Harrow, Middlesex, United Kingdom

Status

Recruiting

Address

St Mark's Hospital

Harrow, Middlesex, HA1 3UJ

John Radcliffe Hospital, Oxford, Oxfordshire, United Kingdom

Status

Recruiting

Address

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU

Royal Hallamshire Hospital, Sheffield, South Yorkshire, United Kingdom

Status

Recruiting

Address

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF

Queen Elizabeth University Hospital, Glasgow, Strathclyde, United Kingdom

Status

Recruiting

Address

Queen Elizabeth University Hospital

Glasgow, Strathclyde, G51 4TF

Neath Port Talbot Hospital, Swansea, West Glamorgan, United Kingdom

Status

Recruiting

Address

Neath Port Talbot Hospital

Swansea, West Glamorgan, SA12 7BX

St Thomas' Hospital, London, United Kingdom

Status

Recruiting

Address

St Thomas' Hospital

London, , SE1 7EH

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