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    Summary
    EudraCT Number:2019-002550-23
    Sponsor's Protocol Code Number:HS0003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-29
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-002550-23
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
    STUDIO DI FASE 3, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO, MULTICENTRICO, VOLTO A VALUTARE L’EFFICACIA E LA SICUREZZA DI BIMEKIZUMAB NEI PARTECIPANTI ALLO STUDIO CON IDROSADENITE SUPPURATIVA DA MODERATA A GRAVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa.
    Studio volto a valutare l'efficacia e la sicurezza di Bimekizumab nei partecipanti allo studio con idrosadenite suppurativa da moderata a grave.
    A.3.2Name or abbreviated title of the trial where available
    BE HEARD I
    BE HEARD I
    A.4.1Sponsor's protocol code numberHS0003
    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 SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 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 nameBimekizumab
    D.3.2Product code [UCB4940]
    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.3.8INN - Proposed INNBimekizumab
    D.3.9.1CAS number 1418205-77-2
    D.3.9.2Current sponsor codeUCB4940
    D.3.9.4EV Substance CodeSUB182636
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 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
    Idrosadenite suppurativa
    E.1.1.1Medical condition in easily understood language
    Hidradenitis Suppurativa, a chronic skin disease that appears after puberty, may lead to painful nodules and scarring in armpits, groin and other areas. Nodules may rupture to form draining tunnels.
    L'Hidradenitis Suppurativa, una malattia cronica della pelle che compare dopo la pubertà, può portare a noduli dolorosi e cicatrici nelle ascelle, nell'inguine e in altre aree. I noduli possono romper
    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 20.0
    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
    Evaluate the efficacy of bimekizumab in study participants with moderate to severe Hidradenitis Suppurativa (HS)
    Valutazione dell’efficacia di bimekizumab nei partecipanti allo studio affetti da idrosadenite suppurativa (HS) da moderata a grave.
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy of bimekizumab on other measures of disease activity in study participants with moderate to severe HS
    - Evaluate the safety of bimekizumab in study participants with moderate to severe HS
    - Valutazione dell’efficacia di bimekizumab rispetto ad altre misurazioni dell’attività della malattia dei partecipanti allo studio affetti da HS da moderata a grave;
    - Valutazione della sicurezza di bimekizumab nei partecipanti allo studio affetti da HS da moderata a grave.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: For individuals consenting to the pharmacogenetic substudy, blood samples will be drawn for exploratory genetic/epigenetic analyses at specified timepoints.
    At certain sites, where feasible, representative photographs of the changes in skin will be captured. Photographs will be anonymized. This is optional for study participants and requires a separate informed consent. A decision not to consent does not exclude the study participantfrom the study.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Per le persone che acconsentono al sottostudio farmacogenetico, saranno prelevati campioni di sangue per analisi genetiche/epigenetiche esplorative in punti prestabiliti.
    In alcuni siti, ove possibile, saranno scattate fotografie rappresentative dei cambiamenti cutanei. Le fotografie saranno rese anonime. Questo è facoltativo per i partecipanti allo studio e richiede un consenso informato separato. La decisione di non dare il consenso non esclude il partecipante allo studio.
    E.3Principal inclusion criteria
    - Participant must be at least 18 years of age, at the time of signing the informed consent. If a study participant is under the local age of consentand is at least 18 years of age, written informed consent will be obtainedfrom both the study participant and the legal representative
    - Study participants must have a diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit
    - Study participant must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits
    - Study participant must have moderate to severe HS defined as a total of > or = 5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits
    - Study participant must have had an inadequate response to a course of a systemic antibiotic for treatment of HS as assessed by the Investigatorthrough study participant interview and review of medical history
    - A female study participant is eligible to participate if she is not
    pregnant, not breastfeeding, and at least one of the following conditions applies:
    a) Not a woman of childbearing potential (WOCBP)
    OR
    b) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 20 weeks after the last dose of investigational medicinal product (IMP)
    - Il partecipante deve avere almeno 18 anni di età, al momento della firma del consenso informato. Se un partecipante allo studio ha meno dell'età locale di consenso e ha almeno 18 anni, il consenso informato scritto sarà ottenuto sia dal partecipante allo studio che dal rappresentante legale
    - I partecipanti allo studio devono avere una diagnosi di idrosadenite suppurativa (HS) basata sulla storia clinica e sulla valutazione fisica per almeno 6 mesi prima della visita di base
    - Il partecipante allo studio deve avere lesioni HS presenti in almeno 2 aree anatomiche distinte (es. ascella destra e sinistra), di cui 1 deve essere almeno in stadio II o III di Hurley sia alla visita di screening che alla visita basale.
    - Il partecipante allo studio deve avere un HS da moderato a grave definito come un totale di lesioni infiammatorie (cioè, numero di ascessi più numero di noduli infiammatori) > o = 5 sia alle visite di screening che a quelle basale
    - Il partecipante allo studio deve aver avuto una risposta inadeguata a un trattamento con antibiotico sistemico per il trattamento dell'HS, come valutato dallo sperimentatore attraverso il colloquio con il partecipante allo studio e l'esame della storia medica.
    - Una partecipante donna allo studio ha diritto a partecipare se non è
    incinta, non allatta, e si applica almeno una delle seguenti condizioni:
    a) Non una donna in età fertile (WOCBP)
    OPPURE
    b) Una WOCBP che accetti di seguire le linee guida contraccettive durante il periodo di trattamento e per almeno 20 settimane dopo l'ultima dose di medicinale in fase di sperimentazione (PMI)
    E.4Principal exclusion criteria
    - Draining tunnel count of >20 at the Baseline Visit
    - Any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the Investigator, interfere with the assessment of hidradenitis suppurativa (HS)
    - Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD)
    - Primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant, or has had a splenectomy
    - Female who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP)
    - Active infection or history of certain infection(s)
    - Active tuberculosis (TB) infection, latent TB infection, high risk of exposure to TB infection, current or history of nontuberculous mycobacterium (NTM) infection
    - Concurrent malignancy. Study participants with a history of malignancy within the past 5 years prior to the Screening Visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has been treated and is considered cured
    - History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
    - Known hypersensitivity to any components of bimekizumab or comparative drugs as stated in this protocol
    - Concomitant and prior medication restrictions
    - Myocardial infarction or stroke within the 6 months prior to the Screening Visit
    - Presence of active suicidal ideation, or moderately severe major depression or severe major depression
    - Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
    - Conteggio dei tunnel di drenaggio >20 alla visita basale
    - Qualsiasi altra malattia o condizione cutanea attiva (ad esempio, cellulite batterica, candida intertrigine, condiloma esteso) che, a parere dello sperimentatore, può interferire con la valutazione dell'hidradenitis suppurativa (HS)
    - Il partecipante allo studio ha una diagnosi di sarcoidosi, lupus eritematoso sistemico, o malattia infiammatoria intestinale attiva (IBD)
    - Condizione immunosoppressiva primaria, compresa l'assunzione di terapia immunosoppressiva a seguito di un trapianto d'organo, o ha subito una splenectomia
    - Femmina che sta allattando, è incinta o ha intenzione di rimanere incinta durante lo studio o entro 20 settimane dalla dose finale del medicinale in fase di sperimentazione (IMP)
    - Infezione attiva o alcune infezioni pregresse
    - Infezione da tubercolosi attiva (TBC), infezione da TBC latente, alto rischio di esposizione all'infezione da TBC, corrente o pregressa infezione da micobatterio non tubercoloso (NTM)
    - Malignità concomitante.I partecipanti allo studio con una storia di malignità negli ultimi 5 anni prima della visita di screening sono esclusi, ad ECCEZIONE dei casi in cui la malignità era un carcinoma squamoso cutaneo o basocellulare, o un tumore del collo dell'utero in situ che è stato trattato ed è considerato guarito.
    - Storia di un disturbo linfoproliferativo che include un linfoma o segni e sintomi attuali che suggeriscono una malattia linfoproliferativa
    - Nota ipersensibilità a qualsiasi componente del bimekizumab o di farmaci simili, come indicato nel presente protocollo
    - Restrizioni concomitanti e precedenti relative al farmaco
    - Infarto del miocardio o ictus nei 6 mesi precedenti la visita di screening
    - Presenza di un'ideazione suicida attiva, o di una depressione maggiore moderatamente grave o di una grave depressione maggiore
    - Il soggetto ha una storia di abuso cronico di alcol o droghe nei 6 mesi precedenti lo screening
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16.
    Percentuale di partecipanti che raggiungono una risposta clinica come misurato da Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) alla settimana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Settimana 16
    E.5.2Secondary end point(s)
    1. Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16
    2. Percentage of participants with Flare by Week 16
    3. Absolute change from Baseline in Skin Pain score at Week 16
    4. Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
    5. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
    6. Percentage of participants with serious adverse events (SAEs) during the study
    7. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
    1. Percentuale di partecipanti che hanno ottenuto la risposta clinica misurata da Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) alla settimana 16
    2. Percentuale di partecipanti con arrossamenti entro la settimana 16
    3. Cambiamento assoluto rispetto al punteggio del basale per il doore alla pelle alla settimana 16
    4. Cambiamento assoluto rispetto al basale in Dermatologia Indice di qualità della vita (DLQI) Punteggio totale alla 16a settimana
    5. Percentuale di partecipanti con eventi avversi emergenti dal trattamento (TEAE) durante lo studio
    6. Percentuale di partecipanti con eventi avversi gravi (SAE) durante lo studio
    7. Percentuale di partecipanti con eventi avversi di natura terapeutica (TEAE) che portano al ritiro dallo studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2: Week 16
    3, 4: From Baseline (Day 1) to Week 16
    5, 6, 7:From Baseline (Day 1) until Safety Follow-Up (up to Week 71)
    1, 2: Settimana 16
    3, 4: dal Basale (giorno 1) alla Settimana 16
    5, 6, 7: dal Basale (giorno 1) fino al Follow-Up di sicurezza (fino alla Settimana 71)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Immunogenicity
    Tollerabilità, Immunogenicità
    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) Yes
    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 trial4
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    Denmark
    France
    Germany
    Greece
    Israel
    Italy
    Netherlands
    Norway
    Spain
    Switzerland
    Turkey
    United States
    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
    LVLS
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years3
    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: 485
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 253
    F.4.2.2In the whole clinical trial 490
    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)
    Eligible subjects will be allowed to enroll in an extension study.
    I soggetti che possono essere ammessi potranno iscriversi ad uno studio di estensione.
    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 Decision2020-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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