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    Summary
    EudraCT Number:2016-003425-42
    Sponsor's Protocol Code Number:PS0009
    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:2021-02-11
    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 number2016-003425-42
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis
    STUDIO DI FASE 3, MULTICENTRICO, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO E COMPARATORE ATTIVO, A GRUPPI PARALLELI PER VALUTARE L¿EFFICACIA E LA SICUREZZA DI BIMEKIZUMAB IN SOGGETTI ADULTI AFFETTI DA PSORIASI A PLACCHE CRONICA 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 compared to placebo and an active comparator in adult subjects with moderate to severe chronic plaque psoriasis
    Studio per valutare l¿efficacia e la sicurezza di bimekizumab rispetto al placebo e al medicinale di confronto attivo in soggetti adulti affetti da psoriasi a placche cronica da moderata a grave
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberPS0009
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03370133
    A.5.4Other Identifiers
    Name:-Number:-
    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 CodeSUB182636
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number155
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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
    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.3.2Product code [NA]
    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 INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor code-
    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 typeequal
    D.3.10.3Concentration number90
    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
    Moderate to Severe Chronic Plaque Psoriasis
    Psoriasi a placche cronica da moderata a grave
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe Chronic Plaque Psoriasis is a chronic inflammatory disease characterized by changes in the skin.
    La psoriasi a placche cronica da moderata a grave
    ¿ una patologia infiammatoria cronica caratterizzata da alterazione della cute
    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 10071117
    E.1.2Term Plaque psoriasis
    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
    Compare the efficacy of bimekizumab administered for 16 weeks versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO)
    Confrontare l¿efficacia di bimekizumab somministrato per 16 settimane rispetto a placebo nel trattamento di soggetti affetti da psoriasi (PSO) a placche cronica da moderata a grave
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy of bimekizumab compared to placebo at achieving complete clearance (PASI100) after 16 weeks of treatment
    - Evaluate the efficacy of bimekizumab compared to placebo after 4 weeks of treatment
    - Evaluate the efficacy of bimekizumab compared to ustekinumab after 4 weeks, 12 weeks, 16 weeks, and 52 weeks of treatment
    - Evaluate the change in itch, pain, and scaling of bimekizumab compared to placebo after 16 weeks of treatment as reported by subjects using the Patient Symptom Diary
    - Evaluate the change in psoriatic scalp disease of bimekizumab compared to placebo after 16 weeks of treatment in subjects with scalp PSO at Baseline
    - Assess Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment
    - Valutare l¿efficacia di bimekizumab rispetto a placebo in termini di raggiungimento di una clearance completa (PASI 100) dopo 16 settimane di trattamento
    - Valutare l¿efficacia di bimekizumab rispetto a placebo dopo 4 settimane di trattamento
    - Valutare l¿efficacia di bimekizumab rispetto a ustekinumab dopo 4 settimane, 12 settimane, 16 settimane e 52 settimane di trattamento
    - Valutare i cambiamenti a livello di prurito, dolore e desquamazione con bimekizumab rispetto a placebo dopo 16 settimane di trattamento, come riportato dai soggetti tramite il Diario dei sintomi del paziente
    - Valutare i cambiamenti a livello di psoriasi del cuoio capelluto con bimekizumab rispetto a placebo dopo 16 settimane di trattamento in soggetti con PSO del cuoio capelluto al basale
    ¿ Valutare gli eventi avversi emergenti dal trattamento (TEAE), gli eventi avversi seri (SAE) e i TEAE che conducono al ritiro dallo studio, adeguati in base alla durata dell¿esposizione del soggetto al trattamento dello stu
    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: Genomic, genetic, epigenetic, proteins, and metabolite biomarkers may
    be measured in the substudy.
    Selected sites in the US will participate in the photography substudy.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Nel sottostudio potranno essere misurati i biomarcatori genomici, genetici, epigenetici, delle proteine e dei metaboliti.
    Al sottostudio di fotografia parteciperanno centri selezionati negli Stati Uniti.
    E.3Principal inclusion criteria
    - Must be at least 18 years of age
    - Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
    - Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator’s Global Assessment (IGA) score >=3 on a 5-point scale
    - Subject is a candidate for systemic PSO therapy and/or phototherapy
    - Female subject of child bearing potential must be willing to use highly effective method of contraception
    - Avere almeno 18 anni d’età
    - Psoriasi (PSO) a placche cronica per almeno 6 mesi prima della visita di screening
    - Indice di estensione e gravità della psoriasi (PASI) >=12 e area della superficie corporea (BSA) interessata da PSO >=10% e punteggio della valutazione globale dello sperimentatore (IGA) >=3 su una scala da 5 punti
    - Il soggetto è candidato alla terapia sistemica per la PSO e/o fototerapia
    - I soggetti femminili in età fertile devono essere disposti a usare un metodo di contraccezione altamente efficace
    E.4Principal exclusion criteria
    - Subject has an active infection (except common cold), a recent serious infection, or a history of
    opportunistic or recurrent chronic infections
    - Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV)
    infection
    - 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 any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
    - Presence of active suicidal ideation or positive suicide behavior
    - Presence of moderately severe major depression or severe major depression
    - 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
    - Il soggetto ha un’infezione attiva (eccetto il comune raffreddore), una recente infezione grave o anamnesi di infezioni opportunistiche o croniche ricorrenti
    - Il soggetto ha un’infezione concomitante da epatite B o C virale acuta o cronica o da virus dell’immunodeficienza umana (HIV)
    - Il soggetto presenta infezione da tubercolosi (TB) nota, è sottoposto a un elevato rischio di contrarre un’infezione da TB, o un’infezione micobatterica non tubercolare (NTMBI) attuale o pregressa
    - Il soggetto presenta qualsiasi altra condizione, anche medica o psichiatrica, che, secondo il parere dello Sperimentatore, renderebbe il soggetto non idoneo a essere incluso nello studio
    - Presenza di ideazione suicida attiva o comportamento suicida positivo
    - Presenza di depressione maggiore moderatamente grave o di grave depressione maggiore
    - 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 carcinoma a cellule basali trattati e considerati curati, o il carcinoma cervicale in situ
    E.5 End points
    E.5.1Primary end point(s)
    1. Psoriasis Area and Severity Index 90 (PASI90) response at Week 16
    2. Investigator's Global Assessment (IGA) response at Week 16
    1. Esito con punteggio pari a 90 dell’Indice di estensione e gravità della psoriasi (PASI 90) alla Settimana 16
    2. Esito della Valutazione globale dello sperimentatore (IGA) alla Settimana 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2: Week 16
    1-2: Settimana 16
    E.5.2Secondary end point(s)
    1. PASI100 response at Week 16
    2. PASI75 response at Week 4
    3. Patient Symptom Diary response for itch at Week 16
    4. Patient Symptom Diary response for pain at Week 16
    5. Patient Symptom Diary response for scaling at Week 16
    6. Scalp IGA response (Clear or Almost Clear with at least a 2-category improvement from Baseline) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline
    7. PASI90 response at Week 12
    8. PASI90 response at Week 52
    9. IGA response at Week 12
    10. IGA response at Week 52
    11. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by
    duration of subject exposure to study treatment
    12. Number of Serious Adverse Events (SAEs) adjusted by duration of
    subject exposure to study treatment
    13. Number of Treatment Emergent Adverse Events (TEAEs) leading towithdrawal adjusted by duration of subject exposure to study treatment
    1. Esito PASI 100 alla Settimana 16
    2. Esito PASI 75 alla Settimana 4
    3. Diario dei sintomi del paziente - risposta al prurito alla Settimana 16
    4. Diario dei sintomi del paziente - risposta al dolore alla Settimana 16
    5. Diario dei sintomi del paziente - risposta allo scaling alla Settimana 16
    6. Esito IGA del cuoio capelluto (libero o quasi libero con almeno un miglioramento di categoria 2 rispetto al basale) alla Settimana 16 per i soggetti con psoriasi (PSO) del cuoio capelluto al basale
    7. Esito PASI 90 alla Settimana 12
    8. Esito PASI 90 alla Settimana 52
    9. Esito IGA alla Settimana 12
    10. Esito IGA alla Settimana 52
    11. Numero di eventi avversi emergenti dal trattamento (TEAE), adeguato in base alla durata dell¿esposizione del soggetto al trattamento dello studio
    12. Numero di eventi avversi seri (SAE), adeguato in base alla durata dell¿esposizione del soggetto al trattamento dello studio
    13. Numero di eventi avversi emergenti dal trattamento (TEAE) che conducono al ritiro dalla studio, adeguato in base alla durata dell¿esposizione del soggetto al trattamento dello studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3, 4, 5, 6: Week 16
    2: Week 4
    7, 9: Week 12
    8, 10: Week 52
    11,12,13: From Baseline to Safety Follow Up (up to Week 72)
    1, 3, 4, 5, 6: Settimana 16
    2: Settimana 4
    7, 9: Settimana 12
    8, 10: Settimana 52
    11, 12, 13: Dal basale al follow-up di sicurezza (fino alla Settimana 72)
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Tolerability
    Immunogenicit¿, Tollerabilit¿
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Belgium
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    United Kingdom
    Czechia
    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 years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days17
    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: 520
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 560
    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 open-label study.
    Ai soggetti elegibili sar¿ permesso di essere arruolati per uno studio in aperto.
    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 Decision2018-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-01
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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