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    Summary
    EudraCT Number:2012-002763-10
    Sponsor's Protocol Code Number:VB-201-079
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-05
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-002763-10
    A.3Full title of the trial
    A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients with Moderate to Severe Plaque Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to Evaluate the Efficacy and Safety of the oral study medication VB-201 in Patients with Moderate to Severe Plaque Psoriasis
    A.4.1Sponsor's protocol code numberVB-201-079
    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 organisationSCIderm GmbH
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressDrehbahn 1-3
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20354
    B.5.3.4CountryGermany
    B.5.4Telephone number49040554401141
    B.5.5Fax number49040554401291
    B.5.6E-mailkonstanze.eisfeld@sciderm.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 nameVB-201
    D.3.2Product code VB-201, formerly CI-201
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    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
    Patients with Moderate to Severe Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    Patients with Moderate to Severe Psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.2System Organ Class 100000004858
    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 patients with psoriasis.

    Efficacy Objective
    Stage 1: To examine the effect of treatment with two different doses of VB-201 compared to placebo (initial 16 weeks) on measures of disease activity in patients with psoriasis.
    Stage 2: To examine the effect of treatment with two different doses of VB-201 compared to placebo (24 weeks) on measures of disease activity in patients with psoriasis.

    Exploratory Biomarker
    To examine the effect of up to 24 weeks treatment with two different doses of VB-201 as compared with placebo on inflammatory related biomarkers.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 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 subjects, ≥18 to ≤75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months prior to screening;
    3. Plaque psoriasis covering between 10% to 30 % of body surface area (BSA);
    4. PASI severity moderate to severe, scoring at least 10 but no higher than 20;
    5. For a female subject; either:
    - subject is of non-childbearing potential, defined as: menopause with amenorrhea >2 years, hysterectomy, or bilateral oopherectomy
    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;
    Males must use at least one method of contraception (e.g., condom) throughout the study;
    6. 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
    1. The subject presents with psoriasis that is predominantly guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis;
    2. Received any investigational drug within 30 days of screening;
    3. Previous participation in a VB-201 study;
    4. Previously received or is currently receiving systemic biologic treatment for psoriasis (e.g. ustekinumab, adalimumab, etanercept, etc);
    5. The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline: Topical psoriasis treatments: 2 weeks; Systemic (non-biologic) psoriasis treatments: 4 weeks or 5 half-lives
    (whichever is longer); Phototherapy: 4 weeks
    6. The subject anticipates getting enough ultra-violet light during the study (e.g. sunbathing; tanning salon, etc.) to cause psoriasis to improve;
    7. 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);
    8. 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;
    9. Subjects 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: WBC <3.5 103/μL; Hgb <10 g/dL; platelets <120 103/μL; neutrophils absolute <1.5 103/μL; lymphocytes absolute <0.8 103/μL) or Creatinine 1.25-times the upper limit of normal (ULN);
    Note: 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.
    10. History of cancer, the exception is skin cancer, see below. Subjects with >3 previous squamous cell skin cancer lesions are excluded; Subjects who had histologically controlled excision of basal cell
    and/or squamous cell carcinoma of the skin and have been declared to have no evidence of tumor can be enrolled; Subjects who had basal cell and/or squamous cell carcinoma of the skin removed and have not met these criteria can be enrolled if the
    skin cancer was removed >3 years prior to study participation and there is no evidence of recurrence;
    11. Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of baseline, or a history or presence of recurrent or chronic infection [e.g. viral infections, (including hepatitis B or C, HIV), bacterial infections, systemic fungal infections, or syphilis];
    12. Evidence of tuberculosis as indicated by a positive Quantiferon test at screening or within 30 days prior to screening;
    13. Chest X-ray within 3 months of screening visit suggestive of tuberculosis or active fungal infection;
    14. History of substance abuse, including alcohol abuse, within the past year;
    15. Has a history of or has a current, clinically significant major psychiatric disorder (e.g., major depressive disorder, psychosis, schizophrenia) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth
    Edition (DSM-IV-TR). [Exception: Subjects with depression that has been adequately controlled for at least 6 months may enroll in the study];
    16. Female subject with a positive pregnancy test or nursing, or planning a pregnancy during the course of the study;
    17. Subjects with a QTc-prolongation > 470msec, risk factors for torsades de pointes such as heart failure NYHA II-IV, hypokalaemia, family history of long QT syndrome and subjects using concomitant medication that prolongs the QT interval
    18. Unwilling or unable to comply with study requirements
    E.5 End points
    E.5.1Primary end point(s)
    Stage 1 Primary Efficacy Endpoints
    The primary efficacy analysis for Stage 1 will include the MITT Population and compare the proportions (%) of Patients achieving a PASI 50 response in the VB-201 160 mg (80 mg BID) group to the placebo group at Week 16 This analysis will be performed using the Chi-square test. The null hypothesis of equality of PASI 50 response rates will be assessed using a two-sided test at the 5% level of significance. The primary efficacy analyses will also be completed in a Per-Protocol population.

    Stage 2 Primary Efficacy Endpoints
    The primary efficacy analysis for Stage 2 will include the MITT Population and compare the proportions (%) of Patients achieving a PASI 50 response in the VB-201 160 mg (80 mg BID) group to the placebo group at Week 24. For week 24 placebo group efficacy responses, modeling of the trajectory of response for the placebo group during weeks 0-16 is to be used to determine the placebo week 24 values for all endpoints. This analysis will be performed using the Chi-square test. The null hypothesis of equality of PASI 50 response rates will be assessed using a two-sided test at the 5% level of significance. The primary efficacy analyses will also be completed in a Per-Protocol population.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stage 1: week 16
    Stage 2: week 24
    E.5.2Secondary end point(s)
    Stage 1 Secondary Efficacy Endpoints
    1. Proportion of subjects in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups who achieve at least 75% improvement from the baseline PASI score (PASI 75) at Week 16 compared to the proportion of PASI 75 responders in the placebo group;
    2. The mean change in the PASI score from baseline to Week 16 in each of the two VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the mean change in the placebo group.
    3. Change in affected Body Surface Area (BSA) from baseline to Week 16 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo;
    4. Change in PGA scores from baseline to Week 16 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment
    groups compared to the placebo group, to include analyses of: (a) proportion with PGA score of 0-1, and (b) proportion with PGA score of 4-5;
    5. Change in Patient Psoriasis Global Assessment scores from baseline to Week 16 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group;
    6. The proportion of subjects in the VB-201 80 mg/day treatment group who achieve at least 50% improvement from the baseline PASI score at Week 16 (PASI 50) compared to the proportion of PASI 50 responders in the placebo group.

    Stage 2 Secondary Efficacy Endpoints
    1. Proportion of subjects in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups who achieve at least 75% improvement from the baseline PASI score (PASI 75) at Week 24 compared to the proportion of PASI 75 responders in the placebo group;
    2. The mean change in the PASI score from baseline to Week 24 in each of the two VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the mean change in the placebo group.
    3. Change in affected Body Surface Area (BSA) from baseline to Week 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo;
    4. Change in PGA scores from baseline to Week 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment
    groups compared to the placebo group, to include analyses of: (a) proportion with PGA score of 0-1, and (b) proportion with PGA score of 4-5;
    5. Change in Patient Psoriasis Global Assessment scores from baseline to Week 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Stage 1: week 16
    Stage 2: 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 No
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dose-Ranging
    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 trial3
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Germany
    Israel
    Poland
    Spain
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 180
    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)
    Patients who prematurely withdraw from the study will be treated if indicated as for any event still ongoing at the end of a clinical study according to standard practice under supervision by an experienced dermatologist or will be referred to a dermatologic practice for further treatment according to standard practice. In the case of premature discontinuation due to an AE, the investigator should ensure that the patient receives a suitable therapy appropriate to patient’s condition.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-26
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