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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
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    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
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    EudraCT Number:2016-003427-30
    Sponsor's Protocol Code Number:PS0014
    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
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-003427-30
    A.3Full title of the trial
    A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis
    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 adult subjects with moderate to severe chronic plaque psoriasis
    Studio per valutare l'efficacia e la sicurezza di bimekizumab in soggetti adulti con 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 numberPS0014
    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.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.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.5.4Telephone number000000
    B.5.5Fax number000000
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    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 da moderata a cronica
    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 da moderata a cronica è una malattia infiammatoria cronica caratterizzata da cambiamenti nella pelle.
    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
    Assess the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis.
    Valutare la sicurezza e la tollerabilità a lungo termine di bimekizumab in soggetti adulti affetti da psoriasi a placche cronica da moderata a grave.
    E.2.2Secondary objectives of the trial
    - Assess the safety of maintenance therapy bimekizumab dose regimens as measured by Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) leading to study withdrawal
    - Assess the efficacy of maintenance therapy bimekizumab dose regimens as measured by Psoriasis Area Severity Index 90 (PASI90; defined as a subject who achieves 90% reduction in the PASI score from the feeder study Baseline) and Investigator's Global Assessment (IGA) response (Clear or Almost Clear with at least a 2 category improvement from Baseline on a 5-point scale)
    - Valutare la sicurezza della terapia di mantenimento con regimi di dosaggio di bimekizumab
    ssecondo quanto misurato mediante gli eventi avversi gravi (SAE) e gli eventi avversi emergenti dal trattamento (TEAE) che comportano il ritiro dallo studio.
    - Valutare l’efficacia della terapia di mantenimento con regimi di dosaggio di bimekizumab secondo quanto misurato mediante l’Indice di estensione e gravità della psoriasi 90 (PASI90; definito come un soggetto che raggiunge una riduzione del 90% nel punteggio PASI ispetto al basale dello studio precedente) e l’esito della valutazione globale dello sperimentatore (IGA) (remissione completa o quasi completa con miglioramento di almeno 2 categorie rispetto al basale su una scala a 5 punti).
    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: There are two sub-studies, DV0002 and DV0006.
    The purpose of the sub-studies is to evaluate the safe and effective use of self-injecting device presentations (ie, prefilled safety syringe and auto-injector presentations) for subcutaneous (sc) selfinjection of bimekizumab by subjects in the US, Canada (DV0002) and in select sites in Europe, Japan (DV0006).

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Ci sono due sottostudi, DV0002 e DV0006.
    Lo scopo dei sottostudi è quello di valutare l'uso sicuro ed efficace delle presentazioni dei dispositivi di auto-iniezione (per esempio, presentazioni di siringhe di sicurezza pre-riempite e auto-iniettori) per auto-iniezione sottocutanea (sc) di bimekizumab in soggetti che vivono negli Stati Uniti e in Canada (DV0002) e in una selezione di siti in Europa e Giappone (DV0006).
    E.3Principal inclusion criteria
    - Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
    - Subject completes the feeder study (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013 [NCT03410992]) without meeting any withdrawal criteria
    - Female subjects must be:
    a) Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
    b) Permanently sterilized (eg, hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
    c) Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014
    - Il soggetto è considerato affidabile e capace di aderire al protocollo (ad es. capace di comprendere e compilare dei diari), alla programmazione delle visite e all’assunzione del farmaco secondo il giudizio dello sperimentatore.
    - Il soggetto ha completato lo studio precedente (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013 [NCT03410992]) senza soddisfare alcun criterio di ritiro.
    - I soggetti di sesso femminile devono:
    a) Essere in post-menopausa: la menopausa è definita come 12 mesi consecutivi di amenorrea per la quale non vi sia alcuna altra causa evidente, patologica o fisiologica
    b) Presentare un’anamnesi di sterilizzazione definitiva (per es., isterectomia, salpingectomia bilaterale, ovariectomia bilaterale)
    c) Oppure, se in età fertile (e sessualmente attivi, con conseguente potenziale procreazione), essere disposti a utilizzare un metodo contraccettivo altamente efficace per tutta la durata dello studio fino a 20 settimane dopo l’ultima somministrazione del prodotto medicinale sperimentale (IMP) e aver presentato un test di gravidanza negativo in occasione della visita finale dello studio precedente/visita basale dello studio PS0014
    E.4Principal exclusion criteria
    - Subject has previously participated in this study
    - Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication
    - Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject's entry into PS0014, although the decision on whether to enroll the subject remains with the investigator
    - Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
    - Subject may not participate in another study of a medicinal product or device under investigation other than the substudy
    - Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen.
    - Il soggetto ha partecipato in precedenza a questo studio.
    - I soggetti di sesso femminile che intendono rimanere incinte durante lo studio o nelle 20 settimane successive all’ultima dose del farmaco dello studio.
    - Il soggetto presenta qualsiasi condizione medica o psichiatrica che, a giudizio dello sperimentatore, potrebbe mettere a rischio o compromettere la capacità del soggetto di partecipare a questo studio. Nota: prima dell’ingresso nello studio PS0014 di qualsiasi soggetto con un evento avverso serio (SAE) in corso o un’anamnesi di infezioni gravi nell’ambito dello studio precedente, è necessario consultare il responsabile del monitoraggio medico, sebbene la decisione relativa all’opportunità di arruolare il soggetto spetti sempre allo sperimentatore
    - Il soggetto presenta un risultato positivo o indeterminato del test di rilascio dell’interferone gamma (IGRA) in uno studio precedente, salvo se adeguatamente valutato e trattato
    - Il soggetto non può partecipare a un altro studio su un prodotto medicinale o dispositivo medico sperimentale (fatta eccezione per il sottostudio).
    - Il soggetto presenta un'anamnesi di abuso cronico di alcool o sostanze stupefacenti nei sei mesi precedenti al basale, secondo quanto valutato in base all'anamnesi medica, al colloquio presso il centro e/o ai risultati del test tossicologico specificato sulle urine.
    E.5 End points
    E.5.1Primary end point(s)
    Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to Investigational Medicinal Product (IMP)
    Numero di eventi avversi emergenti dal trattamento (TEAE) rettificato in base alla durata dell'esposizione del soggetto al medicinale in fase di sperimentazione (IMP).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to Safety Follow Up (up to Week 160)
    Dal basale al follow up di sicurezza (fino alla settimana 160)
    E.5.2Secondary end point(s)
    1. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to IMP
    2. Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to IMP
    3. Psoriasis Area Severity Index 90 (PASI90) response at Week 144
    4. Investigator´s Global Assessment (IGA) response at Week 144
    1. Numero di eventi avversi gravi (SAE) rettificato in base alla durata dell'esposizione all'IMP.
    2. Numero di TEAE, che portano al ritiro della sperimentazione, corretto in base alla durata dell'esposizione all'IMP.
    3. Risposta dell'indice di gravità dell'area della psoriasi 90 (PASI90) alla settimana 144
    4. Risposta dello sperimentatore sulla valutazione globale (IGA) alla Settimana 144
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2: From Baseline to Safety Follow Up (up to week 160)
    3, 4: Week 144
    1,2: dal basale al follow up di sicurezza (fino alla settimana 160)
    3, 4: settimana 144.
    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 No
    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. 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Gruppo singolo (i soggetti saranno randomizzati per ricevere il dosaggio 1 o 2
    Single group (Subjects will be randomized to receive dosage regimen 1 or dosage regimen 2)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    Non applicabile
    Not applicable
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    Korea, Republic of
    Russian Federation
    United Kingdom
    United States
    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
    Last Subject Last Visit (LSLV)
    Ultima visita dell'ultimo paziente (Last Subject Last Visit, 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 months9
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days22
    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: 1020
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1120
    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)
    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 Decision2019-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-21
    P. End of Trial
    P.End of Trial StatusOngoing
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