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    Summary
    EudraCT Number:2010-022843-39
    Sponsor's Protocol Code Number:ATN117221
    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:2010-11-11
    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 number2010-022843-39
    A.3Full title of the trial
    Efficacy of oral alitretinoin treatment in patients with palmo-plantar pustulosis (PPP) inadequately responding to standard topical treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of alitretinoin treatment in patients with pustular form of Psoriasis
    A.3.2Name or abbreviated title of the trial where available
    Oral alitretinoin in PPP
    A.4.1Sponsor's protocol code numberATN117221
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01245140
    A.5.4Other Identifiers
    Name:BAP02028Number:BAP02028
    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 SponsorGlaxoSmithKline R&D Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline R&D Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline R&D Ltd
    B.5.2Functional name of contact pointClinical Trials HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressStockley Park West, 1-3 Ironbridge
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number440208990 4466
    B.5.5Fax number440208990 1234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Yes
    D.2.1.1.1Trade name Toctino 30 mg Weichkapseln
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline GmbH & Co. KG
    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.3.1Product namealitretinoin
    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 08/03/5300
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    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
    Palmo-Plantar Pustulosis
    E.1.1.1Medical condition in easily understood language
    Pustular form of 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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10050185
    E.1.2Term Palmoplantar pustulosis
    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
    Determine the response, based on the palmo-plantar pustulosis psoriasis area and severity index (PPPASI) at the end of treatment (week 24).
    E.2.2Secondary objectives of the trial
    - assess the response of pustular lesions to total pustular count
    - assess the response to psoriasis lesions in locations other than the hands to treatment
    - assess the response of nail involvement to treatment
    - collect safety data
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A female subject is eligible to participate if she is of:
    • Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and a follicle-stimulating hormone concentration of 40 international units (IU)/L.
    • Child-bearing potential with negative pregnancy test as determined by a human
    chorionic gonadotropin (hCG) test at screening or prior to dosing and either 1) agrees to use a medically acceptable contraception method for an appropriate
    period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point and continue contraception until the end of the study, or 2) has only same-sex partners, when this is her preferred and usual lifestyle.
    2. Capable of understanding and willing to provide signed and dated written voluntary
    informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
    3. Male or female aged at least 18 years at time of consent and at time of first dose.
    4. Have PPP for at least 6 months, with or without psoriasis lesions on other areas of
    the skin.
    5. A PPPASI score of at least 8 with involvement of at least 10% of the palms and/or the soles.
    6. Refractory to standard topical corticosteroid therapy.
    E.4Principal exclusion criteria
    1. Unable to comply with the requirement of the study.
    2. Female subjects who are pregnant or who plan to become pregnant or who are breast feeding.
    3. Subjects whose disease is adequately controlled by standard non-medicated therapy (skin moisturizing and protection).
    4. Known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil.
    5. Treated with any of the following treatments 4 weeks before the start of study treatment:
    • systemic drugs: corticosteroids, immunosuppressants, methotrexate
    • phototherapy: ultraviolet B light therapy [UVB], psoralen with ultraviolet A
    combination therapy [PUVA], Grenz rays, X-rays
    6. Treated with biologic treatments within 6 weeks prior to start of study treatment.
    7. Abnormal hematology.
    8. Treated with any systemic or topical retinoids within 3 months or 1 month,
    respectively, before start of study treatment.
    9. Treated with high-potency topical corticosteroids within 2 weeks before the start of study treatment.
    10. Severe generalized pustular psoriasis.
    11. A skin condition of palms and/or soles that interferes with the diagnosis of PPP by
    the investigator.
    12. Any condition that, in the judgment of the investigator, would put the subject at
    unacceptable risk for participation in the study.
    13. Hepatic insufficiency, severe renal failure, uncontrolled hypercholesterolemia as characterized by:
    • AST/ ALT > 2.5 x upper limit of normal (ULN)
    • Creatinine clearance <60 mL/min (calculated, Cockcroft-Gault)
    • Fasting triglyceridemia > 1.5 x ULN
    • Fasting cholesterol > 1.5 x ULN
    • Fasting low-density lipoprotein (LDL) cholesterol > 1.5x ULN
    14. Subjects with hypothyroidism as indicated by TSH above ULN and T4 test below LLN or hypervitaminosis A.
    15. Subjects with unstable cardiac disease or poorly controlled cardiovascular risk
    factors, for example:
    • Acute coronary syndrome or coronary revascularization (PCI, CABG) within 3
    months before start of study treatment
    • Poorly controlled diabetes mellitus (HbA1c > 8.5%)
    16. Systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg at
    the screening examination.
    17. Subjects 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.
    18. Subjects included in the study of an investigational drug within 2 months before start of study treatment (3 months for biologics).
    19. Subjects with a score of 20 or more on CES-D, or with active major psychiatric
    disorder (eg, Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar
    Disorder [I or II], or schizophrenia).
    20. Subjects who score a 4 or 5 during the previous 30 days on the CSSRS at Screening or Baseline.
    21. Subjects who have made a suicide attempt within the 6 months preceding the
    Screening or Baseline visits.
    E.5 End points
    E.5.1Primary end point(s)
    PPPASI - calculated for palm or sole. range from 0 (no PPP) to 72 (most severe PPP)
    assesses erythema, number of pustules, desquamation and area involved.

    Pustule count - palms and soles

    Modified Psoriasis Area Severity Index (mPASI) - psoriatic plaques will be evaluated for redness, thickness and scaliness over 4 body regions - head, upper extremities, truck and lower extremities

    Nail Psorisasis Serverity Index (NAPSI) - taken for finger nails only
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    To assess the response of pustular lesions to total pustule count
    To assess the response to psoriasis lesions in locations other than the hands to the treatment
    To assess the response of nail involvement to the treatment
    To collect safety data for alitretinoin
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24 or last visit on treatment
    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 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 Yes
    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 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 EEA7
    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
    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 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 years1
    E.8.9.2In all countries concerned by the trial months6
    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: 20
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 will receive the standard treament of the clinic
    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 Decision2011-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-16
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