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    Summary
    EudraCT Number:2011-005145-12
    Sponsor's Protocol Code Number:HIDRA03
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-21
    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 ConcernedGreece - EOF
    A.2EudraCT number2011-005145-12
    A.3Full title of the trial
    A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED CLINICAL TRIAL OF THE SAFETY AND EFFICACY OF ANAKINRA IN PATIENTS WITH HIDRADENITIS SUPPURATIVA (PROTOCOL: HIDRA03)
    ΜΙΑ ΔΙΠΛΗ ΤΥΦΛΗ, ΤΥΧΑΙΟΠΟΙΗΜΕΝΗ, ΕΛΕΓΧΟΜΕΝΗ ΜΕ ΕΙΚΟΝΙΚΟ ΦΑΡΜΑΚΟ ΚΛΙΝΙΚΗ ΜΕΛΕΤΗ ΓΙΑ ΤΗΝ ΑΣΦΑΛΕΙΑ ΚΑΙ ΤΗΝ ΑΠΟΤΕΛΕΣΜΑΤΙΚΟΤΗΤΑ ΤΟΥ ANAKINRA ΣΕ ΑΣΘΕΝΕΙΣ ΜΕ ΠΥΩΔΗ ΙΔΡΑΔΕΝΙΤΙΔΑ (ΜΕΛΕΤΗ HIDRA 03)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TREATMENT OF HIDRADENITIS SUPPURATIVE WITH ANAKINRA
    ΘΕΡΑΠΕΥΤΙΚΗ ΑΝΤΙΜΕΤΩΠΙΣΗ ΤΗΣ ΠΥΩΔΟΥΣ ΙΔΡΑΔΕΝΙΤΙΔΑΣ ΜΕ ANAKINRA
    A.3.2Name or abbreviated title of the trial where available
    ANAKINRA IN HIDRADENITIS SUPPURATIVA
    ΤΟ ANAKINRA ΣΤΗΝ ΠΥΩΔΗ ΙΔΡΑΔΕΝΙΤΙΔΑ
    A.4.1Sponsor's protocol code numberHIDRA03
    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 of Athens, Medical School
    B.1.3.4CountryGreece
    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 supportHellenic Institute for the Study of Sepsis
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Athens, Medical School
    B.5.2Functional name of contact pointTheodora Kanni
    B.5.3 Address:
    B.5.3.1Street Address1 Rimini Street
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code12462
    B.5.3.4CountryGreece
    B.5.4Telephone number00302105831000985
    B.5.5Fax number00302105326446
    B.5.6E-mailkannidora1@hotmail.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 Anakinra
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.4EV Substance CodeSUB05500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hidradenitis suppurativa
    Πυώδης ιδραδενίτιδα
    E.1.1.1Medical condition in easily understood language
    Reccurent skin boils
    Υποτροπιάζοντα δερματικά αποστήματα
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020041
    E.1.2Term Hidradenitis suppurativa
    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
    The safety and efficacy of anakinra in patients with HS of Hurley II and III stage disease.
    Η ασφάλεια και η αποτελεσματικότητα του anakinra σε ασθενείς με πυώδη ιδραδενίτιδα σταδίου ΙΙ και ΙΙΙ κατά Hurley.
    E.2.2Secondary objectives of the trial
    The effect of anakinra in the ex vivo function of PBMCs of patients with HS.
    Η επίδραση του anakinra στην ex vivo λειτουργία των PBMCs ασθενών με πυώδη ιδραδενίτιδα.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • written informed consent provided by the patient;
    • age above 18 years;
    • diagnosis of HS; and
    • HS of Hurley II or III stage disease
    • γραπτή συγκατάθεση που παρέχεται από τον ασθενή,
    • ηλικία ίση ή μεγαλύτερη των 18 ετών,
    • διάγνωση της πυώδους ιδραδενίτιδας και
    • πυώδης ιδραδενίτιδα σταδίου ΙΙ και ΙΙ κατά Hurley
    E.4Principal exclusion criteria
    • history of systemic lupus erythematosus, of rheumatoid arthritis of of seronegative inflammatory arthritis;
    • any prior administration of any type of anti-TNF therapy over the last six months;
    • administration of any live (attenuated) vaccine over the last 4 weeks;
    • history of recurrent vein thrombosis or embolism compatible with anti-cardiolipin syndrome;
    • any present or smoldering infection;
    • hepatic dysfunction defined as any value of transaminases, of γ-glutamyl transpeptidase or of bilirubin> 2 x upper normal limit;
    • history of haematological or solid tumor malignancy, arterial hypertension, liver cirrhosis, HIV infection, and hepatitis virus B or C infection
    • history of episodes mimicking demyelinating disorders or a definite diagnosis of multiple sclerosis
    • any creatinine value above 1.5 mg/dl
    • intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1mg/kg for the last three weeks;
    • neutropenia defined as <1000 neutrophils/mm3; and
    • pregnancy or lactation
    • ιστορικό συστηματικού ερυθυματώδους λύκου, ρευματοειδούς αρθρίτιδας ή οροαρνητικής φλεγμονώδους αρθρίτιδας,
    • οποιαδήποτε προηγούμενη χορήγηση κάθε τύπου αντί-TNF θεραπείας τους τελευταίους 3 μήνες,
    • χορήγηση οποιουδήποτε ζώντος (εξασθενημένου) εμβολίου τις τελευταίες 4 εβδομάδες,
    • ιστορικό υποτροπιάζουσας φλεβικής θρόμβωσης ή εμβολής συμβατό με το σύνδρομο αντι-καρδιολιπίνης,
    • κάθε παρούσα ή υποβόσκουσα λοίμωξη,
    • ηπατική δυσλειτουργία που ορίζεται ως οποιαδήποτε τιμή τρανσαμινασών, γ-γλουταμυλοτρανσπεπτιδάσης ή χολερυθρίνης > 2x το ανώτατο φυσιολογικό όριο,
    • ιστορικό αιματολογικής ή συμπαγούς οργάνου κακοήθειας, αρτηριακής υπέρτασης, ηπατικής κίρρωσης, HIV λοίμωξης, και λοίμωξης από ιό ηπατίτιδας B και C,
    • ιστορικό επεισοδίων που μιμούνται απομυελινωτικές διαταραχές ή διάγνωση σκλήρυνσης κατά πλάκας,
    • οποιαδήποτε τιμή κρεατινίνης μεγαλύτερη από 1.5 mg/dl
    • πρόσληψη κορτικοστεροειδών που ορίζεται ως καθημερινή πρόσληψη πρεδνιζόνης μεγαλύτερης από ή ισοδύναμη 1mg/kg για τις τελευταίες τρεις εβδομάδες,
    • ουδετεροπενία που ορίζεται ως <1000 ουδετερόφιλα/mm3, και
    • εγκυμοσύνη ή θηλασμός
    E.5 End points
    E.5.1Primary end point(s)
    The safety and efficacy of anakinra in patients with HS of Hurley II and III stage disease. This will be defined by the differences of VAS, of severity scores and of DLQI between the two study groups over visits.
    Η ασφάλεια και η αποτελεσματικότητα του anakinra σε ασθενείς με πυώδη ιδραδενίτιδα σταδίου ΙΙ και ΙΙΙ κατά Hurley. Αυτό θα προσδιοριστεί από τις διαφορές του VAS, των βαθμολογιών σοβαρότητας της νόσου και του DLQI μεταξύ των δύο ομάδων της μελέτης κατά τη διάρκεια των επισκέψεων.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 0, 4, 8, 12, 16, 20 and 24
    Εβδομάδες 0, 4, 8, 12, 16, 20 και 24
    E.5.2Secondary end point(s)
    The effect of anakinra in the ex vivo function of PBMCs of patients with HS. This will be defined by the differences of cytokines produced by PBMCs between the two study groups over visits
    Η επίδραση του anakinra στην ex vivo λειτουργία των PBMCs ασθενών με πυώδη ιδραδενίτιδα. Αυτό θα προσδιοριστεί από τις διαφορές των παραγόμενων κυτταροκινών από τα PBMCs μεταξύ των δύο ομάδων της μελέτης.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 0, 12 and 24
    Εβδομάδες 0, 12 και 24
    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 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 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 concerned2
    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
    November 2013
    Νοέμβριος 2013
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state20
    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)
    Follow-up visits at weeks 16, 20 and 24 after randomization. At every visit the following procedures will be done:
    • Patients will be asked to provide an assessment of the severity of their disease and the investigators will count the type of lesions of the affected areas
    • Ten ml of heparinized venous blood will be sampled from every patient after venipuncture of one forearm vein under aseptic conditions only at week 24
    Παρακολούθηση στις εβδομάδες 16, 20 και 24 μετά την έναρξη της αγωγής. Σε κάθε επίσκεψη θα πρέπει να γίνονται οι ακόλουθες δοκιμασίες:
    • Θα ζητείται από τους ασθενείς να προβάλλουν μία εκτίμηση της σοβαρότητας της νόσου
    • Οι ερευνητές θα μετράνε το είδος των βλαβών
    • Δέκα ml ηπαρινισμένου φλεβικού αίματος θα συλλέγεται από κάθε ασθενή, ύστερα από παρακέντηση μίας φλέβας του πήχεος κάτω από άσηπτες συνθήκες. Αυτό θα γίνει την εβδομάδα 24.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-01
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