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    Summary
    EudraCT Number:2010-023901-36
    Sponsor's Protocol Code Number:UHK-GMD-LOA-04
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-13
    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 - PEI
    A.2EudraCT number2010-023901-36
    A.3Full title of the trial
    Psoriasis-topoproteome under ustekinumab treatment (PIROUETTE-Study)
    - as an interventional observation study (phase IV) within approved label and indication and with minimal invasive taking of skin biopsies
    - as an investigator originated proposal (IOP) / investigator initiated study/trial (IIS/T)
    according to AMG and GCP regulations
    A.3.2Name or abbreviated title of the trial where available
    PIROUETTE-Study
    A.4.1Sponsor's protocol code numberUHK-GMD-LOA-04
    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 SponsorFaculty of Medicine, Otto-von-Guericke-University, Magdeburg
    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 STELARA™ 45 mg injection solution in a pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    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.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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 typeSTELARA™ (= ustekinumab) is a pure human monoclonal IgG1kappa-antibody against interleukin-12/23 and is produced by recombinant DNA-technology in a murine myeloma cell line.
    D.IMP: 2
    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 STELARA™ 90 mg injection solution in a pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV, Turnhoutsweg 30, 2340 Beerse, Belgium
    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.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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 typeSTELARA™ (= ustekinumab) ia a pure human monoclonal IgG1kappa-antibody against interleukin-12/23 and is produced by recombinant DNA-technology in a murine myeloma cell line.
    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
    STELARA™ as IMP will be used in all relevant aspects (indication, contraindications, dosing) completely within the approved label, namely for the treatment of adult patients with moderate to severe plaque psoriasis, who failed to respond to or who have a contraindication to, or are intolerant to other systemic treatments including ciclosporin, methotrexate or PUVA. In this setting a single STELARA™ injection will be given at day 0, week 4 and week 16 with an observation for a total 28 weeks.
    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
    Analysis of the topoproteome of skin tissue under standard treatment of psoriasis with STELARA™ (over 28 weeks of total study duration in 15 patients) by taking skin punch biopsies of a diameter of 6 mm in local anesthesia i) before the beginning of the treatment (from involved and uninvolved psoriatic skin), ii) at week 4 (from originally involved skin), and iii) at week 24 from originally involved and uninvolved skin, representative areas each). The skin tissue will be analyzed by multi epitope ligand cartography (= MELC).
    E.2.2Secondary objectives of the trial
    - Determination of anti-psoriatic treatment efficacy of STELARA™ as well as detection of treatment responders and non-responders by determination of the following established standard parameters in the course of the above mentioned treatment (total of 9 visits): 1) psoriasis area and severity index (PASI), 2) physician`s global assessment (PGA), 3) pruritus score (on a visual analogous scale) and 4) dermatology life quality index (DLQI).
    - Determination of treatment safety by the detection of possibly occuring adverse events, based upon i) questioning the patient for the possible occurence of symptoms, ii) clinical examination including vital parameters, and iii) laboratory testing.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    According to approved label status of STELARA™: adult patients (i.e. age of more than 18 years) with moderate to severe plaque psoriasis, who have failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapies including ciclosporin, methotrexate or PUVA.

    No pre-treatment with STELARA™ in the patient´s history.

    The patient is able to understand the study and capable to give informed consent.
    Written informed consent.

    Psoriasis area and severity index (PASI) of more than 10, or
    involvement of body surface by psoriasis for more than 10 %, or
    DLQI (dermatology life quality index, according to Finlay & Kahn) of more than 10.

    Exclusion of an active or latent tuberculosis by negative tuberculosis-skin-test (negative Tbc Elispot blood test, respectively) and chest x-ray (not older than 6 months).

    Consideration of the following wash-out-intervals before the start of study medication:
    i) 2 weeks for antipsoriatic topical drugs (vitamin D and analogues, dithranol, corticosteroids, tar, tazarotene),
    ii) 4 weeks for conventional antipsoriatic systemic drugs (ciclosporin, methotrexate, fumarates, acitretin),
    iii) 4 weeks for uv-treatment,
    iv) 3 months for etanercept, infliximab, adalimumab, and golimumab,
    v) 6 months for any investigational compound / drug

    In case of treatment with a beta-blocker, ACE-inhibitor, anti-malaria drug (resochin), interferon or lithium: stable medication with these agents for at least 12 weeks before the beginning of the study medication.

    No foreseeable necessity for vaccination with a live-vaccine during 4 weeks before the beginning of the study medication, during 28 weeks of study and during 12 weeks afterwards.

    Willingness to keep natural sun light exposure adequately constant and to avoid the use of artificial uv exposition (solarium).

    Use of anticonception in female study participants under study medication up to 15 weeks after the last injection.
    E.4Principal exclusion criteria
    According to approved label status of STELARA™:
    - Hypersensitivity against the active compound (i.e. ustekinumab) or any other compound of STELARA™.
    - Clinical relevant active infections.
    - Malignancies of recent relevance.
    - Intake of immunosuppressive agents / drugs.
    - Vaccination with live-vaccines.
    - Pregnancy.
    - Breast feeding.

    • Absolute criteria for premature discontinuation of study medication:
    - Clinically significant worsening of disease, defined as an increase of PASI > 25% as compared to the beginning of study medication.
    - Grade 3 systemic toxicity.
    - Grade 4 adverse event or a serious adverse event thought to be related to study medication.
    - Serious infection (grade 3) incl. sepsis syndrome with hypotension.
    - Withdrawal of consent.
    - Need for vaccination with live-vaccine.
    - Occurrence of pregnancy.

    • The treatment may be discontinued under the following conditions:
    - Lack of subject compliance.
    - Significant protocol deviation.
    - Upon decision of the investigator due to serious other reasons.
    E.5 End points
    E.5.1Primary end point(s)
    - The primary endpoint is the antipsoriatic treatment of the study participants with a standard "in-label" STELARA™ medication for 24 weeks. At that time point the last two skin biopsies for topoproteome analysis will be taken and the corresponding individual PASI, PGA, pruritus score and DLQI will be recorded. The following 4 weeks until the final visit at week 28 are considered to be a follow-up period.
    - The primary study parameter is the analysis of topoproteome signature of psoriatic skin for the treatment response to STELARA™ (= ustekinumab).
    - STELARA™ treatment response will be defined as reaching a PASI-50 at week 12 and a PASI-75 at week 24.
    - STELARA™ non-responders (sensu strictu) are defined as patients with a treatment response < PASI 40 at week 12 and/or < PASI 50 at week 24.


    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Proteomic and Topoproteomic
    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 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
    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 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 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
    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 Decision2011-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
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    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
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