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    Summary
    EudraCT Number:2010-024131-16
    Sponsor's Protocol Code Number:UKM10_0019
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-02-04
    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 number2010-024131-16
    A.3Full title of the trial
    Efficacy and Safety of oral Alitretinoin (Toctino®) in the Treatment of Patients with Cutaneous Lupus
    Erythematosus: A Multicentre, Open-Label, Prospective Pilot Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of oral Alitretinoin (Toctino®) in the Treatment of Patients with Cutaneous Lupus
    Erythematosus: A Multicentre, Open-Label, Prospective Pilot Study
    A.3.2Name or abbreviated title of the trial where available
    AliCLE
    A.4.1Sponsor's protocol code numberUKM10_0019
    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 SponsorUniversitätsklinikum Münster
    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 supportGlaxo Smith Kline
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Münster
    B.5.2Functional name of contact pointAnnegret Kuhn
    B.5.3 Address:
    B.5.3.1Street AddressVon-Esmarch-Strasse 58
    B.5.3.2Town/ cityMünster
    B.5.3.3Post code48149
    B.5.3.4CountryGermany
    B.5.4Telephone number00492518352210
    B.5.6E-mailkuhnan@uni-muenster.de
    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 Toctino®
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Smith Kline
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Capsule, soft
    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 INNALITRETINOIN
    D.3.9.1CAS number 5300-03-8
    D.3.9.4EV Substance CodeSUB00344MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Αdult subjects of any ethnicity and either gender with Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of alitretinoin (30 mg per day) in the treatment of Cutaneous Lupus Erythematosus lesions.
    E.1.1.1Medical condition in easily understood language
    Αdult subjects of any ethnicity and either gender with Cutaneous Lupus Erythematosus
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10056509
    E.1.2Term Cutaneous lupus erythematosus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the therapeutic effect of alitretinoin (Toctino®) in the treatment of Cutaneous Lupus Erythematosus
    with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF). Response is defined as a reduction of 50% in the total RCLASI compared to the baseline value ("RCLASI 50")
    E.2.2Secondary objectives of the trial
    • To evaluate the proportion of responders after 12 weeks of treatment
    • To evaluate the treatment effect of alitretinoin (Toctino®) with respect to change from baseline in the total
    RCLASI activity score for skin lesions in comparison to week 12, and to the last day of treatment.
    • Time from start of treatment to first response (time to response).
    • To evaluate the proportion of failures of treatment after 12 and 24 weeks of treatment.
    • To evaluate the Patient Assessment of Global Improvement (PAGI) score as well as subject’s assessment of
    itching and pain assessed by a visual analogue scale (VAS) at baseline, as well as after 12 and 24 weeks of
    treatment.
    • To evaluate the safety and tolerability aspects of alitretinoin (Toctino®) in patients with CLE for the body as a
    whole.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients of any gender aged from 18 to 75 years;
    2. A clinical and histological diagnosis of CLE (DLE, SCLE, LET without major systemic involvement) who
    failed to response to topical corticosteroids;
    3. Total RCLASI activity score of >6 (at least 3 points in at least 2 locations) on an assessment of erythema, scale/
    hyperkeratosis, edema/infiltration and subcutaneous nodule/plaque of the lesion (mucous membrane lesions/
    alopecia excluded);
    4. Women of childbearing potential must agree to use at least one primary method of contraception but preferably
    2 methods of contraception under supervision of the investigator or a gynecologist
    5. Signed informed consent.
    E.4Principal exclusion criteria
    1. Patients unable to comply with the requirements of the study;
    2. Only scarred cutaneous target lesions without activity;
    3. Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal
    involvement, requiring systemic medical treatment for the disease;
    4. Active skin disease other than CLE or another progressive or serious disease that interferes with the study
    outcome;
    5. Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks
    before and during the study;
    6. Active severe infection diseases, including chronic or localized;
    7. Patients with hepatic insufficiency, severe renal failure, or uncontrolled hypercholesterinemia, uncontrolled as
    characterized by:
    i. Fasting triglyceridemia > 1.5 x upper limit of normal (ULN)
    ii. Fasting cholesterol > 1.5 x ULN
    iii. Fasting low-density lipoprotein (LDL) cholesterol > 1.5x ULN
    8. Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication
    component, especially soybean oil and partly hydrogenated soybean oil;
    9. Patients with hypothyroidism or hypervitaminosis A;
    10. Patients with cardiovascular risk factors that would exclude a starting dose of 30 mg of alitretinoin;
    11. Topical corticosteroids within 14 days prior to dosing;
    12. Patients treated with any systemic or topical retinoids within 4 weeks before start of study treatment;
    13. Patients receiving drugs with a potential for drug-drug interaction, such as systemic tetracyclines,
    ketoconazole, or St. John’s Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before start
    of study treatment;
    14. Initiation or change in the dose of any current systemic medication for the treatment of CLE/SLE prior to the
    study (time depending on drug class and half-life);
    15. Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study;
    16. Concomitant treatment with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin,
    thiazides, furosemide, sulfonamides or tolebutamide;
    17. Drugs associated to CLE-induction: terbinafine, hydrochlorothiazide, diltiazem, verapamil, nifedipine,
    nitrendipine, fluorouracil, penicillamine, infliximab, adalimumab, etanercept, pantoprazole;
    18. Participation in another clinical trial including the four week period preceding the study or having received a
    non-licensed drug within the last 3 months prior to the study;
    19. Pregnancy (according to pregnancy test) or nursing.
    20. Patients with hereditary myopathy in patient and family history;
    21. Patients with known rhabdomyolysis in patient history (e.g. musculous-toxic complications in association with statin and fibrate therapy).
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew
    prematurely (Last Observation Carried Forward, LOCF). Response is defined as a reduction of 50% in the total
    RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50")
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpint will be evaluated after the last subject has completed the Study Completion Visit, any repeat
    assessments associated with this visit have been documented and followed-up appropriately by the Investigator, and the database is closed.
    E.5.2Secondary end point(s)
    n.a.
    E.5.2.1Timepoint(s) of evaluation of this end point
    n.a.
    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) Yes
    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 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 concerned3
    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 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
    The study will be completed after the last subject has completed the Study Completion Visit, any repeat
    assessments associated with this visit have been documented and followed-up appropriately by the Investigator, and the database is closed. This would assure that there will be enough time for statistical analysis and interpretation of the study results
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 33
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4 Investigator Network to be involved in the Trial: 2
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-04-30
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