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    Summary
    EudraCT Number:2016-002939-15
    Sponsor's Protocol Code Number:V56502
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2016-002939-15
    A.3Full title of the trial
    A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease.
    Klinické hodnocení fáze 2 posuzující účinnost, bezpečnost a snášenlivost šestitýdenní léčby přípravkem V565 u pacientů s aktivní Crohnovou nemocí.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease.
    A.3.2Name or abbreviated title of the trial where available
    English A six week efficacy, safety and tolerability study of V565 in Crohn’s disease (HarbOR study)
    A.4.1Sponsor's protocol code numberV56502
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVHsquared Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVHsquared Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVHsquared Ltd
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address1 Lower Court, Copley Hill Business Park, Babraham
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB22 3GN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441223837650
    B.5.5Fax number00441223832536
    B.5.6E-mailinfo@vhsquared.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameV565
    D.3.2Product code V565
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot applied for
    D.3.9.2Current sponsor codeV565
    D.3.9.3Other descriptive nameV565
    D.3.9.4EV Substance CodeSUB179186
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number185
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Active Crohn's Disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetics substudy

    A blood sample for exploratory genetic research will be obtained from consenting subjects pre-dose, at Visit 3 (Day 1).
    This sample may be analysed only for genes involved in the drug metabolism, safety, and clinical efficacy of V565. These samples may provide information on how individuals metabolise and react to
    the study drug.

    E.3Principal 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
    E.4Principal 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-TNFα therapy, or any contraindication to anti-TNFα therapy
    5. The use of medications prior to the study or during the study
    with the potential to affect the evaluation of efficacy
    E.5 End points
    E.5.1Primary 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
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 42
    E.5.2Secondary 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).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 14, Day 42, Day 56 (Day 1 as well for PK ) as specified above
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Proof of concept
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Canada
    Czech Republic
    Germany
    Hungary
    Poland
    Slovakia
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 111
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 126
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-08
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