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    Summary
    EudraCT Number:2017-002804-29
    Sponsor's Protocol Code Number:PA0011
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-002804-29
    A.3Full title of the trial
    A MULTICENTER, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN THE TREATMENT OF SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
    STUDIO MULTICENTRICO DI FASE 3, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO, VOLTO A VALUTARE L’EFFICACIA E LA SICUREZZA DI BIMEKIZUMAB NEL TRATTAMENTO DI SOGGETTI CON ARTRITE PSORIASICA ATTIVA
    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 the treatment of subjects with active psoriatic arthritis
    Uno studio atto a valutare l'efficacia e la sicurezza di bimekizumab nel trattamento di soggetti con artrite psoriasica attiva
    A.3.2Name or abbreviated title of the trial where available
    BE COMPLETE
    BE COMPLETE
    A.4.1Sponsor's protocol code numberPA0011
    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 SPRL
    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.5.4Telephone number000000
    B.5.5Fax number000000
    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 CodeSUB130157
    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
    Psoriatic Arthritis
    Artrite psoriasica
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis is a type of inflammatory arthritis that can cause swelling, stiffness and pain in the joints.
    L'artrite psoriasica è un tipo di artrite infiammatoria che può causare gonfiore, rigidità e dolore a livello delle articolazioni
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the clinical efficacy of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFa-IR) subjects with active Psoriatic Arthritis (PsA), as assessed by the American College of Rheumatology 50% improvement (ACR50) response.
    Dimostrare l’efficacia clinica di bimekizumab somministrato per via sottocutanea (sc) rispetto al placebo nel trattamento di soggetti con risposta inadeguata al fattore di necrosi tumorale alfa (TNFa-IR) affetti da artrite psoriasica (PsA) attiva, valutata in base alla risposta di miglioramento del 50% secondo l’American College of Rheumatology (ACR50).
    E.2.2Secondary objectives of the trial
    -Assess the efficacy of bimekizumab compared with placebo
    -Assess the safety and tolerability of bimekizumab
    -Assess the impact of bimekizumab on patient-reported quality of life
    -Assess the impact of bimekizumab on skin psoriasis (PSO) in the subgroup of affected subjects at Baseline
    -Assess the impact of bimekizumab on functional improvement
    -Valutare l’efficacia di bimekizumab rispetto al placebo
    -Valutare la sicurezza e la tollerabilità di bimekizumab
    -Valutare l’impatto di bimekizumab sulla qualità della vita riferita dal paziente
    -Valutare l’impatto di bimekizumab sulla psoriasi (PSO) cutanea nel sottogruppo di soggetti affetti al basale
    -Valutare l’impatto di bimekizumab sul miglioramento funzionale
    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 genomics, genetics, and proteomics substudy, blood samples will be drawn for exploratory genetic/epigenetic, genomic, proteomic, and metabolomics analysis and for candidate exploratory biomarker analyses.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Dagli individui che avranno dato il consenso a sotto-studi di genomica, genetica e proteomica, saranno prelevati dei campioni ematici per analisi genetica/epigenetica, genomica, proteomica e metabolomica oltre che dei possibili biomarker.
    E.3Principal inclusion criteria
    -Subject is male or female at least 18 years of age
    -Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
    -Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
    -Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
    -Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
    -Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(a)) inhibitors for either PsA or PSO
    -Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
    -Il soggetto è di sesso maschile o femminile e ha almeno 18 anni di età
    -I soggetti di sesso femminile devono essere in postmenopausa, permanentemente sterilizzati o disposti a utilizzare un metodo contraccettivo altamente efficace
    -Diagnosi documentata di PsA classificata insorta in età adulta, che soddisfa i Criteri di classificazione per l’artrite psoriasica (CASPAR) da almeno 6 mesi prima dello screening con PsA attiva e che presenta al basale una conta delle articolazioni dolenti (TJC) >=3 su 68 e una conta delle articolazioni tumefatte (SJC) >=3 su 66
    -Il soggetto deve essere negativo per il fattore reumatoide e gli anticorpi anti-peptide ciclico citrullinato (CCP)
    -Il soggetto deve avere almeno 1 o più lesioni psoriasiche attive e/o un’anamnesi documentata di PSO
    -Il soggetto presenta un’anamnesi di risposta inadeguata (mancanza di efficacia dopo almeno 3 mesi di terapia a una dose approvata) o di intolleranza al trattamento con 1 o 2 inibitori del TNFa per PsA o PSO
    - I soggetti che assumono regolarmente NSAIDs, inibitori della ciclo-ossigenasi 2 (COX-2), analgesici (inclusi gli oppioidi blandi), corticosteroidi, metotrexato (MTX), leflunomide (LEF), sulfasalazina (SSZ), hidrossiclorochina (HCQ) E/O apremilast possono essere arruolati se soddisfano i requisiti prima dell'ingresso nello studio.
    E.4Principal exclusion criteria
    -Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
    -Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
    -Subject has an active infection or a history of recent serious infections
    -Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
    -Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
    -Subject had acute anterior uveitis within 6 weeks of Baseline
    -Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
    -Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
    -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
    -Soggetti di sesso femminile in fase di allattamento al seno, incinte o che prevedono di rimanere incinte durante lo studio
    -Soggetti con esposizione attuale o precedente a qualsiasi farmaco biologico, esclusi gli inibitori di TNF, per il trattamento della PsA o PSO
    -Il soggetto presenta un’infezione attiva o anamnesi di infezione seria recente
    -Il soggetto presenta infezione da tubercolosi (TB) nota, è ad elevato rischio di contrarre un’infezione da TB, o presenta un’infezione micobatterica non tubercolare (NTMBI) attuale o pregressa.
    -Il soggetto presenta una diagnosi di condizioni infiammatorie diverse da PSO o PsA. I soggetti con una diagnosi di malattia di Crohn, colite ulcerosa o altra malattia infiammatoria intestinale (IBD) sono ammessi, a condizione che non presentino malattia sintomatica attiva allo screening o al basale
    -Il soggetto ha manifestato uveite anteriore acuta entro 6 settimane dal basale
    -Il soggetto presenta qualsiasi tumore maligno attivo o anamnesi di tumore maligno nei 5 anni precedenti alla visita di screening, ECCETTO il carcinoma cutaneo a cellule squamose o il carcinoma a cellule basali trattato e considerato curato, o il carcinoma della cervice in situ.
    -Il soggetto presenta una forma di PSO diversa dalla tipologia a placche cronica (ad es., PSO pustolosa, eritrodermica e guttata, o PSO farmaco-indotta)
    -Presenza di ideazione suicidaria attiva o evidenza di depressione maggiore moderatamente grave o depressione maggiore grave
    -Il soggetto presenta un’anamnesi di abuso cronico di alcol o sostanze stupefacenti nei 6 mesi precedenti lo screening
    E.5 End points
    E.5.1Primary end point(s)
    American College of Rheumatology 50% improvement (ACR50) response at Week 16
    Risposta di miglioramento del 50% secondo l’American College of Rheumatology (ACR50) alla settimana 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 16
    Basale, settimana 16
    E.5.2Secondary end point(s)
    1. Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
    2. Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
    3. Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
    4. Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16
    5. Minimal Disease Activity (MDA) at Week 16
    6. American College of Rheumatology 20% improvement (ACR20) response at Week 16
    7. American College of Rheumatology 70% improvement (ACR70) response at week 16
    8. Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 4 in the subset of subjects with psoriatic skin lesions at Baseline
    9. Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of subjects with psoriatic skin lesions at Baseline
    10. Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
    11. Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) at Week 16
    12. Incidence of treatment-emergent adverse events (TEAEs) during the study
    13. Incidence of serious adverse events (SAEs) during the study
    14. Adverse events (AEs) leading to withdrawal from investigational medicinal product (IMP) during the study
    1. Risposta PASI90 (Psoriasis Area Severity Index 90) nel sottogruppo di soggetti con PSO che coinvolge almeno il 3% della BSA al basale, alla settimana 4
    2. Risposta PASI90 (Psoriasis Area Severity Index 90) nel sottogruppo di soggetti con PSO che coinvolge almeno il 3% della BSA al basale, alla settimana 16
    3. Variazione rispetto al basale nell’Indice di invalidità del questionario di valutazione dello stato di salute (HAQ-DI) alla Settimana 16
    4. Variazione rispetto al basale nella Sintesi delle componenti fisiche (PCS) del Questionario in forma breve sullo stato di salute a 36 voci (SF-36) alla Settimana 16
    5. Risposta dell’Attività minima della malattia (MDA) alla Settimana 16
    6. Risposta ACR20 (American College of Rheumatology 20% improvement) alla Settimana 16
    7. Risposta ACR70 (American College of Rheumatology 70% improvement) alla Settimana 16
    8. Punteggio della Valutazione globale dello sperimentatore (IGA) pari a 0 (assente) o 1 (quasi assente) E almeno una riduzione di 2 gradi dal basale alla Settimana 4 nel sottogruppo di soggetti con lesioni cutanee psoriasiche al basale
    9. Punteggio della Valutazione globale dello sperimentatore (IGA) pari a 0 (assente) o 1 (quasi assente) E almeno una riduzione di 2 gradi dal basale alla Settimana 16 nel sottogruppo di soggetti con lesioni cutanee psoriasiche al basale
    10. Variazione rispetto al basale nella Valutazione del dolore da artrite da parte del paziente (PtAAP) alla Settimana 16
    11. Variazione rispetto al basale nell’Impatto della malattia nell’artrite psoriasica- 12 (PsAID-12) alla Settimana 16
    12. Incidenza di eventi avversi emergenti dal trattamento (TEAE) durante lo studio
    13. Incidenza di eventi avversi seri (SAE) durante lo studio
    14. Eventi avversi (EA) che portano all’interruzione dell’IMP
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.; 8. Baseline; Week 4
    2.-4.; 6.; 7.; 9.-11. Baseline, Week 16
    5. Week 16
    12.-14. From Baseline until Safety Follow-Up (up to Week 36)
    1.; 8. Basale, Settimana 4
    2.-4.; 6.; 7.; 9-11. Basale, Settimana 16
    5. Settimana 16
    12.-14. Dal Basale fino al Follow-Up di sicurezza (fino alla settimana 36)
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Tolerability
    Immunogenicità, Tollerabilità
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Canada
    Japan
    Russian Federation
    United States
    Czechia
    Germany
    Italy
    Poland
    United Kingdom
    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
    Last subject last visit (LSLV)
    Ultima visita dell'ultimo paziente (LSLV)
    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 days6
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days26
    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: 350
    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 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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 146
    F.4.2.2In the whole clinical trial 390
    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 idonei saranno accettati per 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 Decision2019-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-13
    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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