Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-007170-30
    Sponsor's Protocol Code Number:TUD-Psslan-031
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-01-11
    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 number2007-007170-30
    A.3Full title of the trial
    Untersuchung des Phänotyps und der Funktion proinflammatorischer dendritischer Zellen während einer Therapie der Psoriasis vulgaris mit einem TNFalpha Antagonisten
    Investigation of phenotype and function of proinflammatory dendritic cells during therapy of psoriasis with TNF alpha antagonists
    A.3.2Name or abbreviated title of the trial where available
    Psslan
    A.4.1Sponsor's protocol code numberTUD-Psslan-031
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTechnical University of Dresden, faculty of medicine
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEtanercept
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEtanercept
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeproduced in ovarial cells of chinese hamster(CHO-cells) ,dimeric chimeric protein containing the extracellular binding domain of TNF receptor 2 (TNFR2/p75) bound to the human FC-part of IgG1-antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriasis vulgaris
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the influence of etanercept therapy in adult subjects diagnosed with moderate to severe plaque-type psoriasis on the proinflammatory function of TNFalpha and IL-12/23 secreting myeloid slan dendritic cells in psoriatic skin and blood.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to define slan dendritic cells (DC) as a new and attractive target for the treatment of psoriasis by elucidating their functional impact on the pathogenesis of psoriasis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be ≥18 to 70 years of age at the screening, of either sex and of caucasian race.
    2. Subjects must have had a diagnosis of moderate to severe plaque-type psoriasis for at least 2 months prior to study screening.
    3. Subjects must have plaque-type psoriasis covering 10% of total body surface area and a PASI score of 12 or greater at baseline.
    4. Subjects must be candidates for systemic treatment of psoriasis and have had systemic therapies such as ciclosprin, MTX and PUVA which did not result in sufficient improvement.
    5. Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
    6. Subjects are considered to be eligible according to the following tuberculosis (TB) screening criteria:
    - have no history of latent or active TB prior to screening;
    - have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;
    - have had no recent close contact with a person with active TB or, if there has been such contact, will referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication;
    - within 1 month prior to the first administration of study medication, either have negative diagnostic TB test results (defined as 2 negative tuberculin skin tests) or have a newly identified positive diagnostic TB test result (defined as at least 1 positive tuberculin skin test) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study medication;
    7. Subjects must have a chest x-ray (posterior-anterior and lateral) within 3 months prior to to screening with no evidence of malignancy, infection, fibrosis, or current or old active TB.
    8. The following laboratory tests (CBC, blood chemistry and urine analysis) must be in the normal parameters of the clinical laboratory of the University hospital of Dresden: haemoglobin, white blood cells, neutrophils, platelets, serum creatinine, aspartate aminotransferase, alanine aminotransferase, alkaline phophatase and gamma-glutamyltransferase.
    9. Subjects must be free of any clinically significant disease other than psoriasis or psoriatic arthritis that would interfere with the study evaluations.
    10. Subjects must be willing to give written informed consent and be able to adhere to dose and visit schedules.
    11. Female subjects of childbearing potential and all men bust be using adequate birth control measures (eg abstinence, oral contraceptives, intrauterine device, barrier method with spermicide or surgical sterilization) and must continue using such measures until 6 months after receiving the last dose of study medication.
    12. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at screening and negative urine pregnancy test at baseline.

    E.4Principal exclusion criteria
    1. Subjects who have non-plaque forms of psoriasis (eg erythrodermic, guttata or pustular).
    2. Subjects who have current drug induced psoriasis
    3. Female subjects who are pregnant, nursing, and both men and women who are planning pregnancy during the study period or during the 6 months after receiving of the last dose of study medication.
    4. Subjects who are currently taking or have taken the following drugs within the specified time frame prior to baseline:
    - any therapeutic agent targeted at reducing TNF within 3 months.
    - any biologic within 3 months.
    - any live virus or bacterial vaccinations received within 3 months.
    - any systemic medications/treatments that could affect psoriasis or PASI evaluation within 3 months (2 years for leflunomide, unless being washed out with cholestyramine)
    - any systemic immunosuppressants within 4 weeks.
    - lithium within 4 weeks.
    - any topical medications/treatments that could effect PASI evaluations within 2 weeks.
    5. Subjects who have a history of chronic congestive heart failure, chronic or recurrent infections.
    6. Subjects who have or have had opportunistic infection (eg cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, mycobacteria other than TB) within 6 month prior to screening.
    7. Subjects who have or have had Herpes zoster infection within 2 month prior to screening.
    8. Subjects who are known to be infected with HIV, hepatitis B or hepatitis C.
    9. Subjects who have a history of any clinically significant adverse events (including allergic reactions) to chimeric proteins or human recombinant products.
    10. Subjects who have current signs or symptoms of severe , progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, systemic lupus erythematodes, lymphoproliferative disease.
    11. Subjects who have a history of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.
    12. Subjects who have a transplanted organ.
    13. Subjects who have any known malignancy or a history of malignancy within the previous 5 years (except of basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
    14. Subjects who are known to have had substance abuse (drug or alcohol) problem within the previous 3 years.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the study is the PASI75 response rate at week 24 (PASI is defined as the proportion of subjects achieving a≥75% improvement in PASI from baseline to 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 Yes
    E.6.4Safety No
    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 Yes
    E.6.13.1Other scope of the trial description
    immunological parameters
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    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 state10
    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 Decision2008-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-03
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 10:58:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA