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    Summary
    EudraCT Number:2012-003974-18
    Sponsor's Protocol Code Number:VB-201-064
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-07
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2012-003974-18
    A.3Full title of the trial
    A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis
    A.4.1Sponsor's protocol code numberVB-201-064
    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 SponsorVascular Biogenics Ltd.
    B.1.3.4CountryIsrael
    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 supportVascular Biogenics Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVascular Biogenics Ltd.
    B.5.2Functional name of contact pointVBL
    B.5.3 Address:
    B.5.3.1Street Address6 Jonathan Netanyahu St.
    B.5.3.2Town/ cityOr Yehuda
    B.5.3.3Post code60376
    B.5.3.4CountryIsrael
    B.5.4Telephone number97236346450
    B.5.5Fax number97236346449
    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.3.2Product code VB-201
    D.3.4Pharmaceutical form Capsule, hard
    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 applicable
    D.3.9.1CAS number 630112-41-3
    D.3.9.2Current sponsor codeVB-201
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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, hard
    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
    Mild to Moderate Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Mild to Moderate Ulcerative Colitis
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Safety Objective
    • To examine the safety and tolerability of up to 24 weeks’ treatment with VB-201 or placebo in subjects with UC
    - Efficacy Objective
    • Base Phase: To examine the effect of treatment with VB-201 80 mg BID compared to placebo (initial 12 weeks) on measures of disease activity in subjects with UC.
    • Extension Phase: To examine the effect of longer-term treatment with VB-201 (24 weeks) on measures of disease activity in subjects with UC.
    E.2.2Secondary objectives of the trial
    No secondary objectives were established
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Fully understand all elements of and have signed and dated the written Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent before initiation of protocol-specified procedures;
    2. Male or female, ≥18 years of age, who has a diagnosis of active UC for at least 6 months prior to screening;
    3. A rectal/colonic biopsy obtained previously and consistent with a diagnosis of UC (if not previously obtained, biopsies should be done as part of screening endoscopy);
    4. Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization;
    5. Modified Mayo score of 4 to 10 points (mild to moderate) and Mayo endoscopic score of at least 2 to be confirmed by Central Reader endoscopy video;
    6. Active UC despite previous treatment with at least one 5-aminosalicylic acid (5-ASA) compound at a dose of ≥2000 mg/day for at least 4 weeks or documented intolerance to such therapy;
    7. For a female subject; either: - subject is of non-childbearing potential, defined as: menopause with amenorrhea >2 years, hysterectomy, or bilateral oophorectomy
    OR
    - agrees to continue to use adequate contraception (implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence or vasectomised partner) throughout the study and for at least one month following termination and have a negative pregnancy test at screening and before the first dose of study drug;
    Male subject must use at least one method of contraception (e.g., condom);
    8. In the opinion of the Investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.
    E.4Principal exclusion criteria
    Diagnosis of indeterminate colitis, Crohn’s disease, or clinical findings suggestive of Crohn’s disease (fistula or granulomas on biopsy) or microscopic colitis (collagenous colitis or lymphocytic colitis);
    2. Subject whose symptoms are likely caused by factors other than inflammatory UC, including infection or irritable bowel syndrome (IBS)
    3. History of dysplasia on colonic biopsy;
    Subject with ≥ 8 year history of pancolitis or ≥ 15 year history of left sided colitis unless a colonoscopy with surveillance biopsies to screen for colon cancer has been performed within the past year. If the subject has not had this procedure within the past year, the subject will be required to have a colonoscopy rather than flexible sigmoidoscopy at Screening;
    5. Subject ≥ 50 years of age who has not had a colonoscopy to screen for colorectal polyps and colon cancer within the past 5 years. The subject will be required to have a colonoscopy rather than flexible sigmoidoscopy at Screening;
    6. Subject who has had any prior surgical resection of any part of the colon excluding the appendix;
    7. Subject who has been hospitalized for a UC-related event within 30 days prior to Screening;
    8. Subject who received any investigational drug within 30 days or five half-lives of Screening;
    9. Previous participation in a VB-201 study;
    10. Previous treatment with any biologic product including investigational biologic products within one year prior to baseline visit;
    11. Concomitant and prior medications: subjects should be excluded if they are taking:
    - Systemic corticosteroids unless they have been on a stable dose of one of the following for at least 4 weeks prior to the Baseline Visit:
    • Prednisone up to 20 mg/day or equivalent
    • Budesonide up to 9 mg/day
    If recently discontinued, must have stopped at least 4 weeks prior to the Baseline Visit;
    - Azathioprine/6-mercaptopurine/methotrexate unless the subject has been on such treatment for at least 4 months prior to the Baseline Visit and at a stable dose for at least 8 weeks prior to the Baseline Visit. If recently discontinued, the subject must have stopped at least 4 weeks or 5 half-lives prior to the Baseline Visit;
    - Any other immunosuppressants (e.g. tacrolimus, cyclosporine, mycophenolate mofetil, or leflunomide). If recently discontinued, the subject must have stopped at least 4 weeks or 5 half-lives (which ever is greatest) prior to the Baseline Visit;
    - Oral 5-ASA compounds unless the subject has been on a stable dose at least 4 weeks prior to the Baseline Visit. If recently discontinued, the subject must have stopped at least 4 weeks prior to the Baseline Visit;
    - Rectally administered corticosteroids or 5-ASA are excluded for at least 14 days prior to the Baseline Visit and throughout the study;
    - Antibiotics for the treatment of UC within 14 days of the Baseline Visit and throughout the study (Exception: antibiotics are permitted to treat infections outside of the gastrointestinal tract);
    - Probiotics within 14 days of the Baseline Visit and throughout the study.
    12. The subject has with a stool culture positive for pathogenic ova or parasites, enteric pathogens or Clostridium difficile toxin at the Screening Visit (if initially positive, subjects treated for C. difficile may be re-screened once);
    13. The subject has a known allergy or sensitivity to the study treatment(s) or to any of the excipients contained in the study drug formulation (see list of ingredients in the Investigator’s Brochure);
    14. Any other acute or chronic medical condition that, in the opinion of the Investigator, increases the risk to the subject or the likelihood that the subject will be unable to complete the study (subjects with extra-intestinal manifestations of UC do not fall into this category and are eligible for enrollment into the trial);
    15. Subject with any laboratory test at Screening that common medical practice would deem as significantly abnormal. The following will be deemed as significantly abnormal:
    • alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase ≥2.0-times the upper limit of normal (ULN) or
    • cytopenia (to include any of the following: white blood cells (WBC) <3.5×103/μL; hemoglobin (Hgb) <10 g/dL; platelets <120×103/μL; neutrophils absolute <1.5×103/μL;) or
    • Creatinine ≥1.25-times the ULN;
    If, in the Investigator’s opinion, there is no reason for the test result(s) to be abnormal, the abnormal test(s) may be repeated once during the Screening period.
    16. Presence of, or history of cancer, with the exception of completely excised, non-metastatic squamous cell or basal cell carcinomas of the skin;

    Due to limited space for whole list of exclusion criteria please refer to study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    - Safety will be assessed based on all subjects in the study who have received at least one dose of study drug (Safety Population):
    • Physical examinations;
    • Adverse events (AEs);
    • Vital signs;
    • Laboratory values – clinical chemistry, hematology, urinalysis;
    • Electrocardiograms (ECGs).
    - The primary efficacy endpoint for the Base Phase is proportion of subjects in remission in arm A group compared to arm B at the Week 12 Visit.
    Remission is defined as all of the following:
    1. A total Modified Mayo score of 2 points or lower;
    2. No individual sub-score exceeding 1 point;
    3. No use of any prohibited medications;
    4. No increase in dose of any stable UC related concomitant medications

    The primary efficacy endpoint for the Extension Phase will compare the proportions (%) of subjects achieving a Modified Mayo Score indicating remission between Week 24 in arm A and Week 12 in arm B.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety - every visit
    Efficacy - Week 12
    Extension phase efficacy - Week 24
    E.5.2Secondary end point(s)
    In addition to the primary efficacy analysis, comparisons will be performed between the two arms for the following Base Phase (Day 1- Week 12) secondary efficacy outcomes:
    1. At Week 12, the proportion of responders in each arm; response is defined as all of the following:
    • ≥3-points and at least 30% decrease from the Baseline Visit Modified Mayo Score;
    • ≥1-point decrease from the Baseline Visit in the rectal bleeding component of the Modified Mayo Score or an absolute sub-score for rectal bleeding of 0 or 1;
    • No use of any prohibited medications;
    • No increase in dose of any stable UC related concomitant medications.
    2. At Week 12, the proportion of subjects in each arm with a 2-point or greater decrease in the Modified Mayo score.
    3. Change from Baseline to Week 12 in the modified Baron score, an ordered categorical variable, in arm A compared to arm B.
    4. At Week 12, the proportion of subjects in each arm with mucosal healing, defined as all of the following:
    • An absolute sub-score for endoscopy of 0 or 1 (any degree of friability will receive a score of at least 2);
    • No use of any prohibited medications;
    • No increase in dose of any stable UC related concomitant medications.


    Extension Phase Secondary Efficacy Endpoints:
    The following endpoints will be analyzed:
    1. The proportion of responders at Week 24.
    2. The proportion of subjects at Week 24 with a 2-point or greater decrease in the Modified Mayo score.
    3. Change from Baseline to Week 24 in the modified Baron score, an ordered categorical variable.
    4. At Week 24: The proportion of subjects in each arm with mucosal healing, defined as all of the following:
    • An absolute sub-score for endoscopy of 0 or 1 (any degree of friability will receive a score of at least 2);
    • No use of any prohibited medications;
    • No increase in dose of any stable UC related concomitant medications.
    For each of the above secondary endpoints, the arm A Week 24 result will be compared to: a) the arm B endpoint result at Week 12; b) the arm A result for this endpoint at Week 12. The arm B endpoint result at Week 24 will be compared to the arm B endpoint result at Week 12.
    Additionally, the proportion (%) of subjects achieving a Modified Mayo Score indicating remission at Week 24 in arm A will be compared to the arm A remission result at Week 12; the arm B remission results at Week 24 will be compared to the arm B remission results at Week 12.
    An additional secondary analysis will compare the proportion of subjects in remission at Week 12 in arm A combined with those in remission at Week 24 in arm B to the proportion in remission at Week 12 in arm B.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Base Phase Secondary Endpoints: Week 12
    Extension Phase Secondary Efficacy Endpoints: Week 24
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 Yes
    E.8.1.7Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 104
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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)
    After the clinical trial termination subjects will receive standard medical 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 Decision2013-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-28
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