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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2015-001602-33
    Sponsor's Protocol Code Number:RR15/114
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-001602-33
    A.3Full title of the trial
    A single arm, phase II open label trial to investigate the efficacy and safety of intra-dermal injection of etanercept for remission induction in discoid lupus erythematosus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TARGeted therapy using intradermal injection of ETanercept to treat Discoid Lupus Erythematosus (TARGET-DLE)
    A.3.2Name or abbreviated title of the trial where available
    TARGET-DLE version 2.0
    A.4.1Sponsor's protocol code numberRR15/114
    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 SponsorThe University of Leeds
    B.1.3.4CountryUnited Kingdom
    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 supportNational Institute for Health Research (NIHR)
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportPfizer Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Leeds
    B.5.2Functional name of contact pointJames Goulding
    B.5.3 Address:
    B.5.3.1Street Address2nd Floor, Chapel Allerton Hospital
    B.5.3.2Town/ cityLeeds
    B.5.3.3Post codeLS7 4SA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0113 39 24495
    B.5.5Fax number0113 39 24650
    B.5.6E-mailJ.T.R.Goulding@leeds.ac.uk
    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 10 mg powder and solvent for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    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.3.2Product code EU/1/99/126/022
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEtanercept
    D.3.9.1CAS number 185243-69-0
    D.3.9.2Current sponsor codeRR15/114
    D.3.9.3Other descriptive nameEnbrel
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1 to 10
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Discoid lupus erythematosus
    E.1.1.1Medical condition in easily understood language
    Discoid lupus rash
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10013072
    E.1.2Term Discoid lupus erythematosus
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the proportion of patients with active discoid lupus erythematosus (DLE) that achieves a clinical response as assessed using the modified Limited Score of Activity and Damage in DLE (SADDLE) tool (ie: defined as reduction in modified limited SADDLE score by 20% or more from baseline in the discoid lesion) at Week 12 following treatment with weekly intra-dermal injection of etanercept.
    E.2.2Secondary objectives of the trial
    (i) To assess other efficacy outcomes including Physician’s rating of patient's disease activity using the Visual Analogue Scale (VAS) and daily oral corticosteroid requirement
    (ii) To assess patient-reported outcomes including Dermatology Life Quality Index (DLQI)Questionnaire and Patient’s rating of his/her disease activity using the VAS
    (iii) To report the safety of treatment in terms of side effects and/or reaction to the drug. We will also report whether the treatment leads to progression of patients with DLE only (skin involvement only) to widespread involvement of lupus symptoms; systemic lupus erythematosus (SLE) or makes the patients who are already known SLE worse
    (iv) To assess whether intra-dermal injection of etanercept is associated with absorption of the drug in the blood
    (v) To report whether the patients are willing to undergo the four tests to measure skin inflammation (a) skin biopsy, (b) optical coherence tomography (OCT), (c) infrared thermography and (d) laser
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (i) Adults aged 18-65 years old.
    (ii) Have at least one active DLE lesion, either diagnosed by skin biopsy or confirmation by Consultant Dermatologist/Rheumatologist.
    (iii) Patients with DLE only and SLE patients with DLE are included.
    (iv) Have refractory disease to an anti-malarial at 3 months as assessed by the Dermatologist/Rheumatologist.
    (v) Patients receiving anti-malarials must have been receiving them for at least 3 months prior to Screening, with a stable dose regimen for at least 28 days (±1 day) prior to Baseline (the first study drug administration)
    (vi) Ability to provide an informed consent.
    (vii) All male and female patients biologically capable of having children must agree to use a reliable method of contraception for the duration of the study and for a period of 3 weeks after their final dose of study drug. Acceptable methods of contraception are surgical sterilisation, oral, implantable or injectable hormonal methods, intrauterine devices or barrier contraceptives.
    E.4Principal exclusion criteria
    (i) Any prior treatment with TNF-blockade therapies.
    (ii) Intramuscular or intra-dermal corticosteroid within 28 days of the Screening visit.
    (iii) Oral steroid of greater than 10mg prednisolone daily, or change in oral steroid dose within 28 days prior to the Baseline Visit.
    (iv) A change in the dose of other immunosuppressant including methotrexate, azathioprine and mycophenolate mofetil within 28 days (±1 day) prior to Baseline Visit.
    (v) Concomitant therapies with any alkylating agents (e.g. cyclophosphamide, chlorambucil), other immunosuppressant including sulfasalazine and leflunomide, other biological agent particularly anakinra and abatacept and other experimental drug. If patients are on any of these, they need to be off therapies for at least 28 days prior to Baseline Visit to allow for washout.
    (vi) Evidence of an immunosuppressive state, including an active HIV infection, agammaglobulinaemia, T-cell deficiencies or Human T cell Lymphotrophic Virus Type 1 (HTLV-1).
    (vii) Chronic active infection such as hepatitis B or hepatitis C and tuberculosis. Patients with latent tuberculosis may be included if treated with chemoprophylaxis for at least 2 months before starting the study and to continue chemoprophylaxis for a total of 6 months
    (viii) History of cancer within the last 5 years except for squamous or basal cell skin carcinoma that has been completely excised and treated cervical carcinoma in situ.
    (ix) Demyelinating diseases.
    (x) Moderate to severe heart failure based on New York Heart Association (NYHA) functional class III and IV.
    (xi) Pregnancy.
    (xii) Breastfeeding.
    (xiii) Planned surgery within the study period which is expected to require omission of study medication of 28 days or more.
    (xiv) Receipt of live attenuated vaccine within 28 days prior to the Baseline Visit.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in the modified limited Score of Activity and Damage in DLE (SADDLE) score by 20% or more from baseline in the index lesion at Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    1. Change in Physician’s VAS and daily oral corticosteroid requirement at Week 12.
    2. Change in patient-reported outcomes; DLQI and Patient’s VAS at Week 12.
    3. Incidence of AEs, ARs, SAEs, SARs and SUSARs.
    4. New development or worsening of positive auto-antibodies titres: anti-nuclear antigen (ANA) and anti-double stranded deoxyribonucleic acid (dsDNA), extractable nuclear antigen antibodies (anti-ENAs) and anti-cardiolipin antibody (ACA) at Week 7 and 15.
    5. Change in complement (C3 and C4) levels below the normal limit (if normal at baseline) at Week 7 and 15.
    6. For SLE patients, change in disease activity as assessed using the British Isles Lupus Activity Groups (BILAG)-2004 score and SLE Disease Activity Index (SLEDAI) at Week 7 and 15.
    7. Objective assessment of tissue response using (i) histopathology from skin biopsy – change in grade of histopathologic features (ii) OCT – change in OCT parameters (iii) Infrared thermography – change in the difference in temperature between active DLE and non-active areas and (iv) LDI – change in perfusion per unit blood flow.
    8. Validity of photograph of lesion as an outcome measure.

    Exploratory endpoints:
    1.The proportion of patients who are willing to undergo skin biopsy, OCT, thermography and LDI assessments pre- and post-therapy
    2. Correlation of OCT, thermography, LDI and photograph with the modified limited SADDLE score
    3. Sensitivity and specificity of OCT, thermography, LDI and photograph against the gold standard; histopathologic features from skin biopsy as an outcome measure
    E.5.2.1Timepoint(s) of evaluation of this end point
    As above at Week 12. However for safety end points (Number 3-6), these will be evaluated at Week 15.
    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 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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of the trial is defined as after the last patient has completed the last visit – End of Study Assessment (Visit 15, Week 15).
    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 months10
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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)
    At the end of the study, we will discuss available ongoing treatment options with the participants if required. Treatment with an intra-dermal injection of etanercept will not be automatically funded by the NHS. This is because etanercept is not approved for use in discoid lupus currently. Once the active inflammation is resolved, the discoid lupus can be controlled using an anti-malarial drug or a standard immunosuppressant.

    Should they then develop a further aggravation
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Clinical Research Network Yorkshire and the Humber
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-31
    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-Sat Apr 27 02:02:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA