A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2016-002939-15-DE
• Date of registration: 02/11/2016
• Prospective Registration: Yes
• Primary sponsor: VHsquared Ltd
• Public title: A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease
• Scientific title: A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study).
• Date of first enrolment: 05/04/2017
• Target sample size: 126
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002939-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Proof of concept; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Canada, Czech Republic, Germany, Hungary, Netherlands, Norway, Poland, Slovakia, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: VHsquared Ltd

• Name: Clinical Trial Information Desk
• Affiliation: VHsquared Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
1. History of CD (confirmed by ileocolonoscopy) of at least three
months duration prior to Visit 1
2. CDAI score of =220 to =450 during Screening
3. CRP =5 mg/L (or, if CRP is normal, FCP= 250 µg/g ) at Screening
4. Active CD of ileum and/or colon as determined by the baseline
ileocolonoscopy
5. Female subjects must not be pregnant and male and female subjects must agree to use effective contraception throughout the study and for 90 days after the last dose of study drug.
6. Subject must have failed or experienced intolerance to at least
one of the following: aminosalicylates, corticosteroids; immunosuppressants
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 111
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion criteria:
The main criteria for exclusion are:
1. CD of mouth, stomach, oesophagus or duodenum which, in the
opinion of the Investigator, is likely to be causing symptoms
2. Known history of or suspicion of ulcerative colitis, indeterminate colitis, microscopic colitis, ischaemic co litis or radiation-induced colitis, based on medical history, endoscopy and/or histological findings.
3. Any gastrointestinal (GI) manifestations of CD that might affect
the evaluation of efficacy
4. Prior primary efficacy failure of o r secondary loss of response to
anti-TNFa therapy, or any contraindication to anti-TNFa therapy
5. The use of medications prior to the study or during the study
with the potential to affect the evaluation of efficacy



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Active Crohn's Disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Product Name: V565
Product Code: V565
Pharmaceutical Form: Capsule
INN or Proposed INN: not applied for
Current Sponsor code: V565
Other descriptive name: V565
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 185-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Secondary:
• further characterise the efficacy of V565 in subjects with active CD assessed by changes in CDAI scores &/or inflammatory markers
• assess the effects of V565 based on changes in Abdominal Pain & Stool Frequency instrument (PRO-2) scores
• assess safety & tolerability of V565

Pharmacokinetic:
• determine the concentration of V565 in serum & urine

Exploratory Endoscopy Objectives:
• To investigate the effect of V565 on changes in endoscopic mucosal appearance, evaluated with an overall assessment and the Simple Endoscopic Score for Crohn's Disease (SES-CD), as determined by a central reader

Main Objective: Primary:
To evaluate the efficacy of V565 555 mg three times a day (TID) in subjects with active Crohn’s disease (CD) measured by the proportion of subjects achieving response to therapy. Response is defined as reduction in the Crohn's Disease Activity Index (CDAI) scores and in inflammatory markers (C-reactive protein [CRP] or faecal calprotectin [FCP] at Day 42.

Primary end point(s): Primary Efficacy Endpoint:
• Proportion 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% fro m the baseline value of CRP or FCP

Timepoint(s) of evaluation of this end point: day 42

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Day 14, Day 42, Day 56 (Day 1 as well for PK ) as specified above

Secondary end point(s): Secondary Efficacy Endpoints:
• Proportion of subjects achieving a =100-point reduction in CDAI score and a concomitant reduction of 50% in CRP o r FCP at Day 42
• Proportion of subjects achieving a =70-point reduction in CDAI score at Day 42
• Proportion of subjects achieving a =100-point reduction in CDAI score at Day 42
• Proportion of subjects achieving a CDAI score of <150 CDAI at Day 42
• Changes from Baseline in scores for PRO-2 at Day 14 and Day 42

Safety Endpoints:
• Evaluations of AEs, clinical laboratory results, physical examination findings, ECGs and vital signs throughout the study

Pharmacokinetic Endpoint:
• Serum and urine concentration of V565 prior to first administration of study drug and at Day 14, Day 42, and Day 56. In addition, On Day 1, a post-dose urine sample will be obtained at the site 4 to 8 hours after the first dose of study drug.

Exploratory Endoscopy Endpoints:
• Changes from Baseline in endoscopic mucosal appearance after 42 days treatment evaluated by changes in overall mucosal appearance and changes in SES-CD as determined by a central reader.
Note: this substudy will be limited to subjects with a baseline SES-CD =7 (if ileum and colon are involved) or =4 (if only ileum is involved).

Secondary ID(s)

V56502

2016-002939-15-CZ

Source(s) of Monetary Support

VHsquared Ltd

Ethics review

Status: Approved
Approval date:
Contact: