Clinical trial NCT02976129: A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: VHsquared Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-29
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.
timeFrame: Day 42
Secondary outcomes:
measure: Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.
timeFrame: Day 42
Other outcomes:
measure: Number of Subjects With Improvement in Endoscopic Mucosal Appearance
timeFrame: Day 42
measure: Number of Subjects Achieving CRP Levels Within Normal Limits at Days 14 and 42
timeFrame: Days 14 and 42
measure: Number of Subjects Achieving FCP Levels Within Normal Limits at Day 14 and 42
timeFrame: Days 14 and 42
Locations:
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Clearwater
country: United States
facility: West Central Gastroenterology
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Miami Springs
country: United States
facility: Galiz Research, LLC
state: Florida
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Mount Airy
country: United States
facility: Clinical Trials of America
state: North Carolina
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörtersee
city: Salzburg
country: Austria
facility: LKH - Universitatsklinikum
city: Vienna
country: Austria
facility: AKH - Medizinische Universität Wien
city: Wels
country: Austria
facility: Klinikum Wels Grieskirchen
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
city: London
country: Canada
facility: LHSC - Victoria Hospital
state: Ontario
city: Brno
country: Czechia
facility: Vojenska nemocnice Brno
city: Horovice
country: Czechia
facility: Nemocnice Horovice
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK
city: Praha 4
country: Czechia
facility: Poliklinika MEDICINA PLUS
city: Praha 8
country: Czechia
facility: Mediendo s.r.o.
city: Regensburg
country: Germany
facility: Praxiszentrum Alte Maelzerei
state: Bayern
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
state: Hessen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU
state: Sachsen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel
state: Schleswig
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Brandenburg
country: Germany
facility: Staedisches Klinikum
city: Frankfurt
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Halle
country: Germany
facility: Studiengesellschaft BSF
city: Hamburg
country: Germany
facility: Hamburgisches Forschungsinstitut fuer CED
city: Hamburg
country: Germany
facility: Asklepios Klinik Hamburg
city: Heidelberg
country: Germany
facility: Praxis fuer Magen
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
city: Leipzig
country: Germany
facility: Klinik u Poliklinik f Gastro
city: Balatonfüred
country: Hungary
facility: DRC Gyogyszervizsgalo
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Endomedix Diagnosztikai
city: Győr
country: Hungary
facility: Petz Aladar Hospital
city: Szekszard
country: Hungary
facility: Clinfan Szolgaltato Kft.
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Lørenskog
country: Norway
facility: Akershus universitetssykehus HF
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord-Norge
city: Kielce
country: Poland
facility: Polimedica Centrum Badan, Profilaktyki I Leczenia
city: Knurów
country: Poland
facility: Indywidualna Specjalistyczna
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Poznań
country: Poland
facility: SOLUMED Centrum Medyczne
city: Rzeszów
country: Poland
facility: Gabinet Lekarski Bartosz Korczowski
city: Sopot
country: Poland
facility: Specjalistyczna Praktyka
city: Staszów
country: Poland
facility: KO-MED Centra Kliniczne Staszow
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Health Center Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Center Zemun
city: Niš
country: Serbia
facility: Clinical Center Nis
city: Bardejov
country: Slovakia
facility: Alian s.r.o
city: Bratislava
country: Slovakia
facility: Uni nemocnica Bratislava
city: Humenné
country: Slovakia
facility: Nemocnica A.Lena Humenne, n.o
city: Michalovce
country: Slovakia
facility: Nemocnica s poliklinikou S. Kukuru Michalovce, a.s
city: Nitra
country: Slovakia
facility: KM Management spol. s r.o.
city: Nové Zámky
country: Slovakia
facility: Gastromedic, s.r.o
city: Prešov
country: Slovakia
facility: Gastro I, s.r.o.
city: Rimavská Sobota
country: Slovakia
facility: Svet zdravia a.s.
city: Brovary
country: Ukraine
facility: Brovary Central District Hospital
city: Chernivtsi
country: Ukraine
facility: Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU
city: Dnipro
country: Ukraine
facility: Limited Liability Company Medical Center Family Medicine Clinic
city: Kharkiv
country: Ukraine
facility: Hospital for War Veterans
city: Kharkiv
country: Ukraine
facility: CHI Kharkiv City Clinical Hospital #13
city: Kharkiv
country: Ukraine
facility: Municipal Institution of Public Health Kharkiv City Clinic #9
city: Kharkiv
country: Ukraine
facility: CI of Healthcare Kharkiv Reg Clin Hospital
city: Kherson
country: Ukraine
facility: CI Ye.Ye.Karabelesh Kherson City Clinical Hosp
city: Kirovohrad
country: Ukraine
facility: PPC Atsynus
city: Kyiv
country: Ukraine
facility: LLC Treatment and Diagnostic Center Adonis Plus
city: Kyiv
country: Ukraine
facility: CI of Kyiv RC Kyiv Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: Medical Centre CONSILIUM MEDICAL
city: L'viv
country: Ukraine
facility: Lviv Regional Clinical Hospital
city: Lviv
country: Ukraine
facility: Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC
city: Sumy
country: Ukraine
facility: CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Med Inst
city: Sumy
country: Ukraine
facility: CI of SRC Sumy RCH Dept of Gastroenterology Sumy SU MI
city: Vinnytsia
country: Ukraine
facility: Medical Center Pulse
city: Vinnytsia
country: Ukraine
facility: Private Small Enterprise Medical Center Pulse
city: Vinnytsia
country: Ukraine
facility: Vinnytsia M.I.Pyrogov Regional Clinical Hospital
city: Zaporizhzhia
country: Ukraine
facility: CI City Clinical Hospital #6
city: Zaporizhzhia
country: Ukraine
facility: CI City Hospital #1
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
state: Cambridgeshire
city: Leytonstone
country: United Kingdom
facility: Whipps Cross University Hospital
state: London
city: Harrow
country: United Kingdom
facility: St Mark's Hospital
state: Middlesex
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
state: Strathclyde
city: Swansea
country: United Kingdom
facility: Neath Port Talbot Hospital
state: West Glamorgan
city: London
country: United Kingdom
facility: St Thomas' Hospital
Study officials:
affiliation: VHsquared Ltd.
name: Suhail Nurbhai, MBChB MRCP
role: STUDY_DIRECTOR
References: