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

Crohn's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976129
• Other study ID #: V56502
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: March 8, 2019

Study information

• Verified date: November 2021
• Source: VHsquared Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 a (anti-TNFa) 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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• V565
Daily dosing of V565 three times a day orally for 6 weeks
• Placebo
Daily dosing of placebo three times a day orally for 6 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
VHsquared Ltd.

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Czechia,  Germany,  Hungary,  Netherlands,  Norway,  Poland,  Serbia,  Slovakia,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Subjects With Improvement in Endoscopic Mucosal Appearance	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.	Day 42
Other	Number of Subjects Achieving CRP Levels Within Normal Limits at Days 14 and 42	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	Days 14 and 42
Other	Number of Subjects Achieving FCP Levels Within Normal Limits at Day 14 and 42	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	Days 14 and 42
Primary	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	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.	Day 42