Crohn's DiseasePhase 2HarbORNCT02976129
A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease
A Phase 2 study testing V565 in people with Crohn's Disease, run by VHsquared Ltd. at 94 sites in 13 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease (CD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- V565
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 94 sitesin 13 countries
- Study dates
- Dec 2016to 8 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
94 sites in 13 countries.
94 sites in 13 countries
Ukraine21 sites
Brovary Central District Hospital
Brovary, 07400
Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU
Chernivtsi, 58001
Limited Liability Company Medical Center Family Medicine Clinic
Dnipro, 49038
Hospital for War Veterans
Kharkiv, 61019
CHI Kharkiv City Clinical Hospital #13
Kharkiv, 61124
Municipal Institution of Public Health Kharkiv City Clinic #9
Kharkiv, 61172
CI of Healthcare Kharkiv Reg Clin Hospital
Kharkiv, 61204
CI Ye.Ye.Karabelesh Kherson City Clinical Hosp
Kherson, 73000
PPC Atsynus
Kirovohrad, 25006
LLC Treatment and Diagnostic Center Adonis Plus
Kyiv, 02002
CI of Kyiv RC Kyiv Regional Clinical Hospital
Kyiv, 04107
Medical Centre CONSILIUM MEDICAL
Kyiv, 4050
Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC
Lviv, 79007
Lviv Regional Clinical Hospital
Lviv, 79010
CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Med Inst
Sumy, 40021
CI of SRC Sumy RCH Dept of Gastroenterology Sumy SU MI
Sumy, 40022
Medical Center Pulse
Vinnytsia, 21001
Private Small Enterprise Medical Center Pulse
Vinnytsia, 21001
Vinnytsia M.I.Pyrogov Regional Clinical Hospital
Vinnytsia, 21018
CI City Clinical Hospital #6
Zaporizhzhya, 69035
CI City Hospital #1
Zaporizhzhya, 69104
Germany14 sites
Charite Universitaetsmedizin
Berlin, 12203
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, 13353
Staedisches Klinikum
Brandenburg, 14770
Universitaetsklinikum Carl Gustav Carus TU
Dresden, Saxony, 01307
Agaplesion Markus Krankenhaus
Frankfurt, 60431
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main, Hesse, 60590
Studiengesellschaft BSF
Halle, 06108
Hamburgisches Forschungsinstitut fuer CED
Hamburg, 20251
Asklepios Klinik Hamburg
Hamburg, 22559
Praxis fuer Magen
Heidelberg, 69121
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig, 24105
EUGASTRO GmbH
Leipzig, 04103
Klinik u Poliklinik f Gastro
Leipzig, 04103
Praxiszentrum Alte Maelzerei
Regensburg, Bavaria, 93053
Poland9 sites
Polimedica Centrum Badan, Profilaktyki I Leczenia
Kielce, 25-364
Indywidualna Specjalistyczna
Knurów, 44-190
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362
SOLUMED Centrum Medyczne
Poznan, 60-529
Gabinet Lekarski Bartosz Korczowski
Rzeszów, 35-302
Specjalistyczna Praktyka
Sopot, 81-756
KO-MED Centra Kliniczne Staszow
Staszów, 28-200
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-270
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, 00-632
Slovakia8 sites
Alian s.r.o
Bardejov, 08501
Uni nemocnica Bratislava
Bratislava, 82606
Nemocnica A.Lena Humenne, n.o
Humenné, 06601
Nemocnica s poliklinikou S. Kukuru Michalovce, a.s
Michalovce, 07101
KM Management spol. s r.o.
Nitra, 949 01
Gastromedic, s.r.o
Nové Zámky, 94002
Gastro I, s.r.o.
Prešov, 080 01
Svet zdravia a.s.
Rimavská Sobota, 97901
United Kingdom8 sites
Addenbrookes Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Queen Elizabeth University Hospital
Glasgow, Strathclyde, G51 4TF
St Mark's Hospital
Harrow, Middlesex, HA1 3UJ
Whipps Cross University Hospital
Leytonstone, London, E11 1NR
St Thomas' Hospital
London, SE1 7EH
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
Neath Port Talbot Hospital
Swansea, West Glamorgan, SA12 7BX
Hungary7 sites
DRC Gyogyszervizsgalo
Balatonfüred, 8230
Obudai Egeszsegugyi
Budapest, 1036
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1062
Semmelweis Egyetem
Budapest, 1088
Endomedix Diagnosztikai
Budapest, 1139
Petz Aladar Hospital
Győr, 9024
Clinfan Szolgaltato Kft.
Szekszárd, 7100
United States6 sites
Advanced Research Center, Inc.
Anaheim, California, 92805
West Central Gastroenterology
Clearwater, Florida, 33762
Clinical Research of West Florida
Clearwater, Florida, 33765
Northwestern University
Evanston, Illinois, 60208
Galiz Research, LLC
Miami Springs, Florida, 33166
Clinical Trials of America
Mount Airy, North Carolina, 27030
Czechia5 sites
Vojenska nemocnice Brno
Brno, 636 00
Nemocnice Horovice
Hořovice
Hepato-Gastroenterologie HK
Hradec Králové, 500 12
Poliklinika MEDICINA PLUS
Prague, 14000
Mediendo s.r.o.
Prague, 186 00
Serbia5 sites
Clinical Center of Serbia
Belgrade, 11000
Clinical Health Center Zvezdara
Belgrade, 11000
Military Medical Academy
Belgrade, 11000
Clinical Center Zemun
Belgrade, 11080
Clinical Center Nis
Niš, 18000
Austria4 sites
Klinikum Klagenfurt am Wörtersee
Klagenfurt, 9020
LKH - Universitatsklinikum
Salzburg, 5020
AKH - Medizinische Universität Wien
Vienna, 1090
Klinikum Wels Grieskirchen
Wels, 4600
Canada3 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
London Health Science Centre
London, Ontario, N6A 5A5
LHSC - Victoria Hospital
London, Ontario, N6A 5W9
Netherlands2 sites
Albert Schweitzer Ziekenhuis
Dordrecht, 3318AT
Maastricht University Medical Center
Maastricht, 6229 HX
Norway2 sites
Akershus universitetssykehus HF
Lørenskog, 1478
Universitetssykehuset Nord-Norge
Tromsø, 9019
About this study
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
The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease (CD).
Read the 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
- Being tested
- V565, Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V565Drug
Daily dosing of V565 three times a day orally for 6 weeks
PlaceboDrug
Daily dosing of placebo three times a day orally for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| V565 | Experimental | V565 three times a day (TID) PO for 6 weeks Receives: Drug: V565 |
| Placebo | Placebo comparator | Placebo TID PO for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startDec 2016
- Primary completion8 Mar 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- VHsquared Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suhail Nurbhai, MBChB MRCP, Study director, VHsquared Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976129
- Sponsor's protocol ID
- V56502
- Acronym
- HarbOR
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2016
- Last updated
- 22 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02976129
- Acronym / sponsor ID
- HarbOR / V56502
- Conditions
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- VHsquared Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Posted 22 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V565 | Experimental | Drug: V565V565 three times a day (TID) PO for 6 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo TID PO for 6 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V565Daily dosing of V565 three times a day orally for 6 weeks | Drug | V565 |
| PlaceboDaily dosing of placebo three times a day orally for 6 weeks | Drug | Placebo |
Primary outcome
Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.
Time frame: 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.
1 secondary outcome
Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42.
Time frame: Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suhail Nurbhai, MBChB MRCP study director
VHsquared Ltd.
94 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V565 in people with Crohn's Disease, run by VHsquared Ltd. at 94 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in Ukraine, Germany, Poland, Slovakia, United Kingdom and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.