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    Summary
    EudraCT Number:2015-002321-20
    Sponsor's Protocol Code Number:HIDRA04
    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:2015-06-18
    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 number2015-002321-20
    A.3Full title of the trial
    A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED CLINICAL TRIAL OF THE SAFETY AND EFFICACY OF MABp1, A HUMAN ANTIBODY TARGETING INTERLEUKIN-1ALPHA, IN PATIENTS WITH HIDRADENITIS SUPPURATIVA
    ΜΙΑ ΔΙΠΛΗ ΤΥΦΛΗ, ΤΥΧΑΙΟΠΟΙΗΜΕΝΗ, ΕΛΕΓΧΟΜΕΝΗ ΜΕ ΕΙΚΟΝΙΚΟ ΦΑΡΜΑΚΟ ΚΛΙΝΙΚΗ ΜΕΛΕΤΗ ΓΙΑ ΤΗΝ ΑΣΦΑΛΕΙΑ ΚΑΙ ΤΗΝ ΑΠΟΤΕΛΕΣΜΑΤΙΚΟΤΗΤΑ ΤΟΥ MABp1, ΕΝΟΣ ΑΝΘΡΩΠΕΙΟΥ ΑΝΤΙΣΩΜΑΤΟΣ ΠΟΥ ΔΕΣΜΕΥΕΙ ΤΗΝ ΙΝΤΕΡΛΕΥΚΙΝΗ-1ΑΛΦΑ, ΣΕ ΑΣΘΕΝΕΙΣ ΜΕ ΔΙΑΠΥΗΤΙΚΗ ΙΔΡΩΤΑΔΕΝΙΤΙΔΑ
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A NEW ANTIBODY FOR HIDRADENITIS SUPPURATIVA
    ΕΝΑ ΝΕΟ ΑΝΤΙΣΩΜΑ ΓΙΑ ΤΗ ΔΙΑΠΥΗΤΙΚΗ ΙΔΡΩΤΑΔΕΝΙΤΙΔΑ
    A.3.2Name or abbreviated title of the trial where available
    MABp1 FOR THE MANAGEMENT OF HIDRADENITIS SUPPURATIVA
    ΤΟ MABp1 ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΗΣ ΔΙΑΠΥΗΤΙΚΗΣ ΙΔΡΩΤΑΔΕΝΙΤΙΔΑΣ
    A.4.1Sponsor's protocol code numberHIDRA04
    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 SponsorHellenic Institute for the Study of Sepsis
    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 organisationHellenic Institute for the Study of Sepsis
    B.5.2Functional name of contact pointKyriaki Kanellakopoulou
    B.5.3 Address:
    B.5.3.1Street Address88 Michalakopoulou Street
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code11528
    B.5.3.4CountryGreece
    B.5.4Telephone number+302107480662
    B.5.5Fax number+302107480662
    B.5.6E-mailinsepsis@otenet.gr
    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 No
    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 nameMABp1
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeXILONIX
    D.3.9.3Other descriptive nameMABP1
    D.3.9.4EV Substance CodeSUB170840
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HIDRADENITIS SUPPURATIVA/ACNE INVERSA
    ΔΙΑΠΥΗΤΙΚΗ ΙΔΡΩΤΑΔΕΝΙΤΙΔΑ/ΑΝΑΣΤΡΟΦΗ ΑΚΜΗ
    E.1.1.1Medical condition in easily understood language
    HIDRADENITIS
    ΙΔΡΩΤΑΔΕΝΙΤΙΔΑ
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10020041
    E.1.2Term Hidradenitis suppurativa
    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
    The purpose of this clinical study is to evaluate the safety and the efficacy of MABp1 compared to placebo in patients with moderate to severe hidradenitis suppurativa.
    Ο σκοπός της κλινικής μελέτης που υποβάλλεται είναι να αξιολογήσει την ασφάλεια και την αποτελεσματικότητα του MABp1 σε σύγκριση με εικονικό φάρμακο σε ασθενείς με μέτρια έως σοβαρή διαπυητική ιδρωταδενίτιδα.
    E.2.2Secondary objectives of the trial
    Not applicable
    Δεν εφαρμόζεται
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent provided by the patient
    • Age above or equal to 18 years
    • Diagnosis of hidradenitis suppurativa (HS)
    • Presence of at least three inflamed nodules
    • HS of Hurley II or III stage disease or rapidly progressive HS of stage I
    • Έγγραφη συγκατάθεση από τον ασθενή
    • Ηλικία μεγαλύτερη ή ίση των 18 ετών
    • Διάγνωση της διαπυητικής ιδρωταδενίτιδας (ΣΙ)
    • Παρουσία τουλάχιστον τριών φλεγμονωδών οζιδίων
    • ΔΙ σταδίου ΙΙ ή ΙΙ κατά Hurley ή ταχέως εξελισσόμενη ΔΙ σταδίου Ι
    E.4Principal exclusion criteria
    • History of systemic lupus erythematosus, of rheumatoid arthritis or of seronegative inflammatory arthritis
    • Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer)
    • History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
    • 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 serious bacterial infection namely pneumonia, endocarditis, acute pyelonephritis and intrabdominal infection. These patients can be enrolled once the attending physicians confirm cure by the infection
    • Hepatic dysfunction defined as any value of transaminases, of γ-glutamyl transpeptidase or of bilirubin greater than twofold the 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 lower than 1000 neutrophils/mm3; and
    • Pregnancy or lactation
    • History of tuberculosis (latent or active). This will be excluded according to the procedure defined in the screening of patients (see below)
    • Major surgery within 28 days prior to Day 0
    • 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
    • Παρουσία σοβαρής λοίμωξης και πιο συγκεκριμένα πνευμονίας, ενδοκαρδίτιδας, οξεία πυελονεφρίτιδας και ενδοκοιλιακής λοίμωξης
    • Ηπατική δυσλειτουργία που ορίζεται ως οποιαδήποτε τιμή τρανσαμινασών, γ-γλουταμυλοτρανσπεπτιδάσης ή χολερυθρίνης μεγαλύτερη από το διπλάσιο του ανώτατου φυσιολογικού ορίου
    • Ιστορικό αιματολογικής κακοήθειας ή κακοήθειας συμπαγούς οργάνου, αρτηριακής υπέρτασης ή ηπατικής κίρρωσης
    • Λοίμωξη από τον ιό της ανθρώπινης ανοσοανεπάρκειας (HIV) ή λοίμωξη από τον ιό της ηπατίτιδας B και C
    • Ιστορικό επεισοδίων που μιμούνται απομυελινωτικές διαταραχές ή διάγνωση σκλήρυνσης κατά πλάκας
    • Οποιαδήποτε τιμή κρεατινίνης μεγαλύτερη από 1.5 mg/dl
    • Χρόνια λήψη κορτικοστεροειδών που ορίζεται ως καθημερινή λήψη πρεδνιζόνης μεγαλύτερης από ή ισοδύναμη 1mg/kg για τις τελευταίες τρεις εβδομάδες
    • Ουδετεροπενία, που ορίζεται ως λιγότερο από 1000 ουδετερόφιλα/mm3
    • Εγκυμοσύνη ή θηλασμός
    • Ιστορικό φυματίωσης (λανθάνουσας ή ενεργούς). Αυτή θα αποκλειστεί σύμφωνα με τη διαδικασία που ορίζεται στη διαλογή των ασθενών (βλέπε
    παρακάτω)
    • Μείζονα χειρουργική επέμβαση τις τελευταίες 28 ημέρες πριν από την Ημέρα 0
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy of MABp1 in patients with moderate to severe hidradenitis suppurativa (HS) by HiSCR scoring. This will be assessed by the difference of achievement of positive HiSCR (HS clinical response) score between the treatment group and the comparator placebo group at week 12.
    Η αποτελεσματικότητα του MABp1 σε ασθενείς με μέτρια έως σοβαρή διαπυητική ιδρωταδενίτιδα (ΔΙ) με βάση τη Βαθμολογία Κλινικής Ανταπόκρισης της ΔΙ (HiSCR). Αυτό θα προσδιοριστεί από τη διαφορά στην επίτευξη θετικής βαθμολογίας HiSCR μεταξύ της ομάδας θεραπείας και της ομάδας σύγκρισης του εικονικού φαρμάκου την εβδομάδα 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Εβδομάδα 12
    E.5.2Secondary end point(s)
    • The long-term efficacy of MABp1 in patients with moderate to severe hidradenitis suppurativa by positive HiSCR scoring. This will be assessed by the difference of achievement of HiSCR score between the treatment group and the comparator placebo group at week 24.
    • The short-and long-term efficacy of MABp1 in patients with moderate to severe HS. This will be assessed by the comparisons of all used scoring systems (HiSCR, PGA, DLQI, disease activity, VAS for disease, VAS for pain and modified Sartorius score) on all study visits.
    • The effect of MAbp1 on the time to new exacerbation. This will be assessed by comparing the time to new exacerbation from week 0 between the two groups of treatment.
    • Η μακροπρόθεσμη αποτελεσματικότητα του MABp1 σε ασθενείς με μέτρια έως σοβαρή διαπυητική ιδρωταδενίτιδα με βάση τη θετική βαθμολογία HiSCR. Αυτή θα αξιολογηθεί από τη διαφορά της επίτευξης θετικής βαθμολογίας HiSCR μεταξύ της ομάδας θεραπείας και της ομάδας του εικονικού φαρμάκου σύγκρισης κατά την εβδομάδα 24.
    • Η βραχυπρόθεσμη και μακροπρόθεσμη αποτελεσματικότητα του MABp1 σε ασθενείς με μέτρια έως σοβαρή ΔΙ. Αυτή θα αξιολογηθεί από τις συγκρίσεις όλων των χρησιμοποιούμενων συστημάτων βαθμολόγησης (HiSCR, PGA, DLQI, δραστηριότητα της νόσου, VAS για νόσο, VAS για πόνο και τροποποιημένο Sartorius score) σε όλες τις επισκέψεις της μελέτης.
    • Η επίδραση της MAbp1 στο χρόνο έως τη νέα έξαρση. Αυτή θα εκτιμηθεί συγκρίνοντας τον χρόνο από την εβδομάδα 0 έως τη νέα έξαρση μεταξύ των δύο ομάδων θεραπείας.
    E.5.2.1Timepoint(s) of evaluation of this end point
    In all patient visits
    Σε όλες τις επισκέψεις της μελέτης
    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 No
    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 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
    LVLS
    Τελευταία επίσκεψη τελευταίου ασθενούς
    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 months0
    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 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    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
    Κανένα
    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 Decision2015-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-12
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