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

NCT02976129 | Completed Phase 2 Results

• 1 other identifier: V56502
• Study Type: interventional
• Target: 125
• Locations: 13 countries
• Sites: 94

Brief Summary

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

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (3)

• Number of Subjects With Improvement in Endoscopic Mucosal Appearance

  Day 42

• Number of Subjects Achieving CRP Levels Within Normal Limits at Days 14 and 42

  Days 14 and 42

• Number of Subjects Achieving FCP Levels Within Normal Limits at Day 14 and 42

  Days 14 and 42

Study Arms (2)

V565

EXPERIMENTAL

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

Drug: V565

Placebo

PLACEBO COMPARATOR

Placebo TID PO for 6 weeks

Drug: Placebo

Interventions

V565 DRUG

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

V565

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VHsquared Ltd.: lead

Study Sites (94)

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

Location

West Central Gastroenterology

Clearwater, Florida, 33762, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Galiz Research, LLC

Miami Springs, Florida, 33166, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Clinical Trials of America

Mount Airy, North Carolina, 27030, United States

Location

Klinikum Klagenfurt am Wörtersee

Klagenfurt, 9020, Austria

Location

LKH - Universitatsklinikum

Salzburg, 5020, Austria

Location

AKH - Medizinische Universität Wien

Vienna, 1090, Austria

Location

Klinikum Wels Grieskirchen

Wels, 4600, Austria

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

London Health Science Centre

London, Ontario, N6A 5A5, Canada

Location

LHSC - Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Vojenska nemocnice Brno

Brno, 636 00, Czechia

Location

Nemocnice Horovice

Hořovice, Czechia

Location

Hepato-Gastroenterologie HK

Hradec Králové, 500 12, Czechia

Location

Poliklinika MEDICINA PLUS

Prague, 14000, Czechia

Location

Mediendo s.r.o.

Prague, 186 00, Czechia

Location

Praxiszentrum Alte Maelzerei

Regensburg, Bavaria, 93053, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Carl Gustav Carus TU

Dresden, Saxony, 01307, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig, 24105, Germany

Location

Charite Universitaetsmedizin

Berlin, 12203, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, 13353, Germany

Location

Staedisches Klinikum

Brandenburg, 14770, Germany

Location

Agaplesion Markus Krankenhaus

Frankfurt, 60431, Germany

Location

Studiengesellschaft BSF

Halle, 06108, Germany

Location

Hamburgisches Forschungsinstitut fuer CED

Hamburg, 20251, Germany

Location

Asklepios Klinik Hamburg

Hamburg, 22559, Germany

Location

Praxis fuer Magen

Heidelberg, 69121, Germany

Location

EUGASTRO GmbH

Leipzig, 04103, Germany

Location

Klinik u Poliklinik f Gastro

Leipzig, 04103, Germany

Location

DRC Gyogyszervizsgalo

Balatonfüred, 8230, Hungary

Location

Obudai Egeszsegugyi

Budapest, 1036, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, 1062, Hungary

Location

Semmelweis Egyetem

Budapest, 1088, Hungary

Location

Endomedix Diagnosztikai

Budapest, 1139, Hungary

Location

Petz Aladar Hospital

Győr, 9024, Hungary

Location

Clinfan Szolgaltato Kft.

Szekszárd, 7100, Hungary

Location

Albert Schweitzer Ziekenhuis

Dordrecht, 3318AT, Netherlands

Location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

Akershus universitetssykehus HF

Lørenskog, 1478, Norway

Location

Universitetssykehuset Nord-Norge

Tromsø, 9019, Norway

Location

Polimedica Centrum Badan, Profilaktyki I Leczenia

Kielce, 25-364, Poland

Location

Indywidualna Specjalistyczna

Knurów, 44-190, Poland

Location

KO-MED Centra Kliniczne Lublin II

Lublin, 20-362, Poland

Location

SOLUMED Centrum Medyczne

Poznan, 60-529, Poland

Location

Gabinet Lekarski Bartosz Korczowski

Rzeszów, 35-302, Poland

Location

Specjalistyczna Praktyka

Sopot, 81-756, Poland

Location

KO-MED Centra Kliniczne Staszow

Staszów, 28-200, Poland

Location

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, 71-270, Poland

Location

Centrum Zdrowia Matki, Dziecka i Mlodziezy

Warsaw, 00-632, Poland

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Clinical Health Center Zvezdara

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Clinical Center Zemun

Belgrade, 11080, Serbia

Location

Clinical Center Nis

Niš, 18000, Serbia

Location

Alian s.r.o

Bardejov, 08501, Slovakia

Location

Uni nemocnica Bratislava

Bratislava, 82606, Slovakia

Location

Nemocnica A.Lena Humenne, n.o

Humenné, 06601, Slovakia

Location

Nemocnica s poliklinikou S. Kukuru Michalovce, a.s

Michalovce, 07101, Slovakia

Location

KM Management spol. s r.o.

Nitra, 949 01, Slovakia

Location

Gastromedic, s.r.o

Nové Zámky, 94002, Slovakia

Location

Gastro I, s.r.o.

Prešov, 080 01, Slovakia

Location

Svet zdravia a.s.

Rimavská Sobota, 97901, Slovakia

Location

Brovary Central District Hospital

Brovary, 07400, Ukraine

Location

Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU

Chernivtsi, 58001, Ukraine

Location

Limited Liability Company Medical Center Family Medicine Clinic

Dnipro, 49038, Ukraine

Location

Hospital for War Veterans

Kharkiv, 61019, Ukraine

Location

CHI Kharkiv City Clinical Hospital #13

Kharkiv, 61124, Ukraine

Location

Municipal Institution of Public Health Kharkiv City Clinic #9

Kharkiv, 61172, Ukraine

Location

CI of Healthcare Kharkiv Reg Clin Hospital

Kharkiv, 61204, Ukraine

Location

CI Ye.Ye.Karabelesh Kherson City Clinical Hosp

Kherson, 73000, Ukraine

Location

PPC Atsynus

Kirovohrad, 25006, Ukraine

Location

LLC Treatment and Diagnostic Center Adonis Plus

Kyiv, 02002, Ukraine

Location

CI of Kyiv RC Kyiv Regional Clinical Hospital

Kyiv, 04107, Ukraine

Location

Medical Centre CONSILIUM MEDICAL

Kyiv, 4050, Ukraine

Location

Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC

Lviv, 79007, Ukraine

Location

Lviv Regional Clinical Hospital

Lviv, 79010, Ukraine

Location

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

Sumy, 40021, Ukraine

Location

CI of SRC Sumy RCH Dept of Gastroenterology Sumy SU MI

Sumy, 40022, Ukraine

Location

Medical Center Pulse

Vinnytsia, 21001, Ukraine

Location

Private Small Enterprise Medical Center Pulse

Vinnytsia, 21001, Ukraine

Location

Vinnytsia M.I.Pyrogov Regional Clinical Hospital

Vinnytsia, 21018, Ukraine

Location

CI City Clinical Hospital #6

Zaporizhzhia, 69035, Ukraine

Location

CI City Hospital #1

Zaporizhzhia, 69104, Ukraine

Location

Addenbrookes Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Whipps Cross University Hospital

Leytonstone, London, E11 1NR, United Kingdom

Location

St Mark's Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, Strathclyde, G51 4TF, United Kingdom

Location

Neath Port Talbot Hospital

Swansea, West Glamorgan, SA12 7BX, United Kingdom

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: VHsquared

info@vhsquared.com

+44 (0)1223 837650

Study Officials

• Suhail Nurbhai, MBChB MRCP

  VHsquared Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 29, 2016
• Study Start: December 1, 2016
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: December 22, 2021
• Results First Posted: December 22, 2021

Record last verified: 2021-11

Locations

UA (21); US (6); CZ (5); NL (2); HU (7); CA (3); GB (8); PL (9); SE (5); SL (8); AU (4); NO (2); DE (14)