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    Summary
    EudraCT Number:2011-002920-41
    Sponsor's Protocol Code Number:StelaraPG01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-08-24
    Trial 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 number2011-002920-41
    A.3Full title of the trial
    Open-label Trial of Stelara® (Ustekinumab) In Patients with Pyoderma gangrenosum
    – an open, non-placebo controlled pilot study with 10 patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stelara® (Ustekinumab) treatment in Patients with Pyoderma gangrenosum
    A.3.2Name or abbreviated title of the trial where available
    SPG-Trial
    A.4.1Sponsor's protocol code numberStelaraPG01
    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 SponsorUniversity Hospital Tübingen
    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 supportJanssen-Cilag GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Department of Dermatology
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressLiebermeisterstr. 25
    B.5.3.2Town/ cityTübingen
    B.5.3.3Post code72076
    B.5.3.4CountryGermany
    B.5.4Telephone number00490707129 80836
    B.5.6E-mailtilo.biedermann@med.uni-tuebingen.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 Stelara
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV Turnhoutseweg, 30 B-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.3.1Product nameUstekinumab
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 815610-63-0
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number45 to 90
    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 Yes
    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
    Patients with a clinical diagnosis of Pyoderma gangrenosum
    E.1.1.1Medical condition in easily understood language
    Pyoderma gangrenosum
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10037634
    E.1.2Term Pyoderma gangenosum
    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 confirm the efficacy and immunological response of Stelara® therapy in patients with PG
    E.2.2Secondary objectives of the trial
    - To assess changes in PG-inflammation Score, Wound Score and Visual Analogue Pain Scale (VAPS).

    - To assess the safety and tolerability of Stelara in patients with PG.

    - To assess, where feasible, the functional significance of the expression pattern of inflammatory cytokines, particularly IL-23, in PG tissue as obtained by biopsies before the beginning of and after the treatment with Stelara and by blood samples before, during and after treatment with Stelara
    • Evaluation of the expression of these cytokines and/or associated inflammatory molecules
    • Assessment of the type of Th immune response before, during and after treatment with Stelara
    • Correlation of the results from the analyses mentioned above with the clinical outcome of PG patients.

    - To asses changes in quality of life, including the dermatology Life Quality Index (DLQI)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Clinical diagnosis of PG, previously systemically untreated (with the exception of systemic corticosteroids)

    2. Measurable disease parameters of PG (color photograph with a ruler).

    3. Patients >= 18 years of age

    4. Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.

    5. Written, voluntary informed consent. Consent must include investigational use of parts of the obtained tissue material.

    6. Screening laboratory test results within the following parameters:
    - Haemoglobin ≥10g/dL
    - White blood cells ≥3.5 x 109/L
    - Neutrophils ≥1.5 x 109/L
    - Platelets ≥100 x 109/L
    - Serum creatinine ≤ 1.5 mg/dL (or ≤ 133 mol/L)
    - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels must not exceed three times the upper limit of the normal range for laboratory conducting the test.
    7. Eligible according the tuberculosis (TB) criteria
    E.4Principal exclusion criteria
    1. Female patients who are pregnant or breast-feeding.

    2. Known diagnosis of human immunodeficiency virus (HIV) infection, Hepatitis B or Hepatitis C.

    3. Diagnosed with active or latent TB infection during screening.

    4. Any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

    5. Currently receiving any other biologic agent.

    6. Have previously failed treatment with any therapeutic agent with the exception of systemic corticosteroids.

    7. Have previously received any treatment agent directly targeted at reducing IL-12 and/or IL-23.

    8. Have received, within 2 weeks prior to the first dose of ustekinumab, a live virus or bacterial vaccination.

    9. Have received, or are expected to receive, a BCG vaccination within 12 months prior to screening, during study, or within 12 months after the last administration of study agent.

    10. Have a serious infection (eg sepsis, pneumonia or pyelonephritis).

    11. Have a transplanted organ (with exception of a corneal transplantat in situ).

    12. Have a known history of lymphoproliferative disease.

    13. Have any known malignancies or have history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma with tumor thickness ≤2mm, or cervical carcinoma in situ that has been treated with no evidence of reccurence within 1 year prior to the first administration of study agent).

    14. Have a known hypersenstitivity to ustekinumab or any of its excipients.

    15. Is a prisoner

    16. Participation in another clinical trial whilst this study or within the last 30 days preliminary to this study

    17. Have any condition that, in the opinion of the investigator, would compromise the well being of the patient or the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change of the PG-inflammation SCORE from baseline to week 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 28
    E.5.2Secondary end point(s)
    - Change of PG-adapted RECIST criteria
    - Wound Score and Visual Analogue Pain Scale from baseline to week 28
    - The incidence and grading of adverse events and abnormal laboratory cytometry
    - Cytokine expression of monocytes and T-cells
    - Cytokine and immunohistological studies to analyze the cytokine profile in the punch biopsies of PG patients under Stelara® therapy
    - Analysis of the phenotype and intracellular cytokine profile of Mononuclear cells and lymphocytes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 16 and 28
    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 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 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 end of study is defined as the last patient having completed the 28-week course of treatment or withdrawing from the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 10
    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 state10
    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)
    The treatment period closes with the last dose of Stelara. Further patient treatment will be at the physician’s discretion.
    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 Decision2012-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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