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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
V565
Placebo
Sponsored by
VHsquared Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Advanced Research Center, Inc.
  • West Central Gastroenterology
  • Clinical Research of West Florida
  • Galiz Research, LLC
  • Northwestern University
  • Clinical Trials of America
  • Klinikum Klagenfurt am Wörtersee
  • LKH - Universitatsklinikum
  • AKH - Medizinische Universität Wien
  • Klinikum Wels Grieskirchen
  • Queen Elizabeth II Health Sciences Centre
  • London Health Science Centre
  • LHSC - Victoria Hospital
  • Vojenska nemocnice Brno
  • Nemocnice Horovice
  • Hepato-Gastroenterologie HK
  • Poliklinika MEDICINA PLUS
  • Mediendo s.r.o.
  • Praxiszentrum Alte Maelzerei
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Universitaetsklinikum Carl Gustav Carus TU
  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
  • Charite Universitaetsmedizin
  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  • Staedisches Klinikum
  • Agaplesion Markus Krankenhaus
  • Studiengesellschaft BSF
  • Hamburgisches Forschungsinstitut fuer CED
  • Asklepios Klinik Hamburg
  • Praxis fuer Magen
  • EUGASTRO GmbH
  • Klinik u Poliklinik f Gastro
  • DRC Gyogyszervizsgalo
  • Obudai Egeszsegugyi
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Semmelweis Egyetem
  • Endomedix Diagnosztikai
  • Petz Aladar Hospital
  • Clinfan Szolgaltato Kft.
  • Albert Schweitzer Ziekenhuis
  • Maastricht University Medical Center
  • Akershus universitetssykehus HF
  • Universitetssykehuset Nord-Norge
  • Polimedica Centrum Badan, Profilaktyki I Leczenia
  • Indywidualna Specjalistyczna
  • KO-MED Centra Kliniczne Lublin II
  • SOLUMED Centrum Medyczne
  • Gabinet Lekarski Bartosz Korczowski
  • Specjalistyczna Praktyka
  • KO-MED Centra Kliniczne Staszow
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Centrum Zdrowia Matki, Dziecka i Mlodziezy
  • Clinical Center of Serbia
  • Clinical Health Center Zvezdara
  • Military Medical Academy
  • Clinical Center Zemun
  • Clinical Center Nis
  • Alian s.r.o
  • Uni nemocnica Bratislava
  • Nemocnica A.Lena Humenne, n.o
  • Nemocnica s poliklinikou S. Kukuru Michalovce, a.s
  • KM Management spol. s r.o.
  • Gastromedic, s.r.o
  • Gastro I, s.r.o.
  • Svet zdravia a.s.
  • Brovary Central District Hospital
  • Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU
  • Limited Liability Company Medical Center Family Medicine Clinic
  • Hospital for War Veterans
  • CHI Kharkiv City Clinical Hospital #13
  • Municipal Institution of Public Health Kharkiv City Clinic #9
  • CI of Healthcare Kharkiv Reg Clin Hospital
  • CI Ye.Ye.Karabelesh Kherson City Clinical Hosp
  • PPC Atsynus
  • LLC Treatment and Diagnostic Center Adonis Plus
  • CI of Kyiv RC Kyiv Regional Clinical Hospital
  • Medical Centre CONSILIUM MEDICAL
  • Lviv Regional Clinical Hospital
  • Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC
  • CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Med Inst
  • CI of SRC Sumy RCH Dept of Gastroenterology Sumy SU MI
  • Medical Center Pulse
  • Private Small Enterprise Medical Center Pulse
  • Vinnytsia M.I.Pyrogov Regional Clinical Hospital
  • CI City Clinical Hospital #6
  • CI City Hospital #1
  • Addenbrookes Hospital
  • Whipps Cross University Hospital
  • St Mark's Hospital
  • John Radcliffe Hospital
  • Royal Hallamshire Hospital
  • Queen Elizabeth University Hospital
  • Neath Port Talbot Hospital
  • St Thomas' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

V565

Placebo

Arm Description

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

Placebo TID PO for 6 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.

Full Information

First Posted
November 23, 2016
Last Updated
November 24, 2021
Sponsor
VHsquared Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02976129
Brief Title
A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease
Acronym
HarbOR
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 8, 2019 (Actual)
Study Completion Date
March 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VHsquared Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V565
Arm Type
Experimental
Arm Description
V565 three times a day (TID) PO for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo TID PO for 6 weeks
Intervention Type
Drug
Intervention Name(s)
V565
Intervention Description
Daily dosing of V565 three times a day orally for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily dosing of placebo three times a day orally for 6 weeks
Primary Outcome Measure Information:
Title
Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.
Description
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.
Time Frame
Day 42
Secondary Outcome Measure Information:
Title
Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.
Description
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.
Time Frame
Day 42
Other Pre-specified Outcome Measures:
Title
Number of Subjects With Improvement in Endoscopic Mucosal Appearance
Description
Subjects with a pre-treatment endoscopy Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 7 (4 if disease was confined to ileum) had a post-treatment endoscopy to evaluate changes in mucosal appearance. The central reader of the endoscopies, blinded to treatment and sequence, was asked to grade if video A was better or worse than video B. Pre- and post-treatment videos were randomly assigned to A and B. The endpoint is the number of subjects whose post-treatment endoscopy was better than their pre-treatment endoscopy.
Time Frame
Day 42
Title
Number of Subjects Achieving CRP Levels Within Normal Limits at Days 14 and 42
Description
The number of subjects who entered the study with an elevated CRP who had a CRP level within normal limits at Days 14 and 42. Normal levels defined as CRP less than or equal to 5mg/L
Time Frame
Days 14 and 42
Title
Number of Subjects Achieving FCP Levels Within Normal Limits at Day 14 and 42
Description
The number of subjects who entered the study with an elevated FCP who had an FCP level within normal limits at Days 14 and 42. Normal limits of FCP defined as less than or equal to 250µg/g
Time Frame
Days 14 and 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suhail Nurbhai, MBChB MRCP
Organizational Affiliation
VHsquared Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
West Central Gastroenterology
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33762
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Galiz Research, LLC
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Clinical Trials of America
City
Mount Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
Facility Name
Klinikum Klagenfurt am Wörtersee
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
LKH - Universitatsklinikum
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AKH - Medizinische Universität Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinikum Wels Grieskirchen
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
London Health Science Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
LHSC - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Vojenska nemocnice Brno
City
Brno
ZIP/Postal Code
636 00
Country
Czechia
Facility Name
Nemocnice Horovice
City
Horovice
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Poliklinika MEDICINA PLUS
City
Praha 4
ZIP/Postal Code
14000
Country
Czechia
Facility Name
Mediendo s.r.o.
City
Praha 8
ZIP/Postal Code
186 00
Country
Czechia
Facility Name
Praxiszentrum Alte Maelzerei
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus TU
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
City
Kiel
State/Province
Schleswig
ZIP/Postal Code
24105
Country
Germany
Facility Name
Charite Universitaetsmedizin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Staedisches Klinikum
City
Brandenburg
ZIP/Postal Code
14770
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus
City
Frankfurt
ZIP/Postal Code
60431
Country
Germany
Facility Name
Studiengesellschaft BSF
City
Halle
ZIP/Postal Code
06108
Country
Germany
Facility Name
Hamburgisches Forschungsinstitut fuer CED
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Asklepios Klinik Hamburg
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Praxis fuer Magen
City
Heidelberg
ZIP/Postal Code
69121
Country
Germany
Facility Name
EUGASTRO GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinik u Poliklinik f Gastro
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
DRC Gyogyszervizsgalo
City
Balatonfüred
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Obudai Egeszsegugyi
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Endomedix Diagnosztikai
City
Budapest
ZIP/Postal Code
1139
Country
Hungary
Facility Name
Petz Aladar Hospital
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Clinfan Szolgaltato Kft.
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
ZIP/Postal Code
3318AT
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Akershus universitetssykehus HF
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Universitetssykehuset Nord-Norge
City
Tromsø
ZIP/Postal Code
9019
Country
Norway
Facility Name
Polimedica Centrum Badan, Profilaktyki I Leczenia
City
Kielce
ZIP/Postal Code
25-364
Country
Poland
Facility Name
Indywidualna Specjalistyczna
City
Knurów
ZIP/Postal Code
44-190
Country
Poland
Facility Name
KO-MED Centra Kliniczne Lublin II
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
SOLUMED Centrum Medyczne
City
Poznań
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Gabinet Lekarski Bartosz Korczowski
City
Rzeszów
ZIP/Postal Code
35-302
Country
Poland
Facility Name
Specjalistyczna Praktyka
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
KO-MED Centra Kliniczne Staszow
City
Staszów
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Twoja Przychodnia-Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-270
Country
Poland
Facility Name
Centrum Zdrowia Matki, Dziecka i Mlodziezy
City
Warszawa
ZIP/Postal Code
00-632
Country
Poland
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Health Center Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Zemun
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Nis
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Alian s.r.o
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Facility Name
Uni nemocnica Bratislava
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Nemocnica A.Lena Humenne, n.o
City
Humenné
ZIP/Postal Code
06601
Country
Slovakia
Facility Name
Nemocnica s poliklinikou S. Kukuru Michalovce, a.s
City
Michalovce
ZIP/Postal Code
07101
Country
Slovakia
Facility Name
KM Management spol. s r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Gastromedic, s.r.o
City
Nové Zámky
ZIP/Postal Code
94002
Country
Slovakia
Facility Name
Gastro I, s.r.o.
City
Prešov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Svet zdravia a.s.
City
Rimavská Sobota
ZIP/Postal Code
97901
Country
Slovakia
Facility Name
Brovary Central District Hospital
City
Brovary
ZIP/Postal Code
07400
Country
Ukraine
Facility Name
Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Limited Liability Company Medical Center Family Medicine Clinic
City
Dnipro
ZIP/Postal Code
49038
Country
Ukraine
Facility Name
Hospital for War Veterans
City
Kharkiv
ZIP/Postal Code
61019
Country
Ukraine
Facility Name
CHI Kharkiv City Clinical Hospital #13
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
Municipal Institution of Public Health Kharkiv City Clinic #9
City
Kharkiv
ZIP/Postal Code
61172
Country
Ukraine
Facility Name
CI of Healthcare Kharkiv Reg Clin Hospital
City
Kharkiv
ZIP/Postal Code
61204
Country
Ukraine
Facility Name
CI Ye.Ye.Karabelesh Kherson City Clinical Hosp
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
PPC Atsynus
City
Kirovohrad
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
LLC Treatment and Diagnostic Center Adonis Plus
City
Kyiv
ZIP/Postal Code
02002
Country
Ukraine
Facility Name
CI of Kyiv RC Kyiv Regional Clinical Hospital
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Medical Centre CONSILIUM MEDICAL
City
Kyiv
ZIP/Postal Code
4050
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
L'viv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC
City
Lviv
ZIP/Postal Code
79007
Country
Ukraine
Facility Name
CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Med Inst
City
Sumy
ZIP/Postal Code
40021
Country
Ukraine
Facility Name
CI of SRC Sumy RCH Dept of Gastroenterology Sumy SU MI
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Medical Center Pulse
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
Private Small Enterprise Medical Center Pulse
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
Vinnytsia M.I.Pyrogov Regional Clinical Hospital
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
CI City Clinical Hospital #6
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
CI City Hospital #1
City
Zaporizhzhia
ZIP/Postal Code
69104
Country
Ukraine
Facility Name
Addenbrookes Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
Leytonstone
State/Province
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
St Mark's Hospital
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Neath Port Talbot Hospital
City
Swansea
State/Province
West Glamorgan
ZIP/Postal Code
SA12 7BX
Country
United Kingdom
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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