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    Summary
    EudraCT Number:2017-001002-15
    Sponsor's Protocol Code Number:AS0009
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-10-02
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-001002-15
    A.3Full title of the trial
    A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis
    Estudio de Extensión, Abierto, Multicéntrico, para Evaluar la Seguridad y Eficacia a Largo Plazo de Bimekizumab en Pacientes con Espondilitis Anquilosante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis
    Estudio para Evaluar la Seguridad y Eficacia a Largo Plazo de Bimekizumab en Pacientes con Espondilitis Anquilosante
    A.3.2Name or abbreviated title of the trial where available
    To assess the long term safety & tolerability of bimekizumab in subjects with ankylosing spondylitis
    Evaluar seguridad y eficacia a largo plazo de bimekizumab en pacientes con espondilitis anquilosante
    A.4.1Sponsor's protocol code numberAS0009
    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 SPRL
    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 number00492173482180
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ankylosing Spondylitis
    Espondilitis Anquilosante
    E.1.1.1Medical condition in easily understood language
    Ankylosing Spondylitis is a form of arthritis that primarily affects the spine.
    La Espondilitis Anquilosante es un tipo de artritis que afecta principalmente a la columna vertebral
    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 PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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
    administered over a period of up to 4 years.
    Evaluar la seguridad y eficacia a largo plazo de bimekizumab administrado durante un periodo de hasta 4 años
    E.2.2Secondary objectives of the trial
    Assess the long-term efficacy of bimekizumab.
    Evaluar la eficacia a largo plazo de bimekizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF) is signed and dated by the subject or by legal representative.
    - Subject or legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, or medication intake according to the judgment of the Investigator.
    - In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
    - Subject completed AS0008 without meeting any withdrawal criteria.
    - An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF) is signed and dated by the subject or by legal representative.
    - Subject or legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, or medication intake according to the judgment of the Investigator.
    - Female subjects must be postmenopausal, permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) 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 until 20 weeks after last administration of IMP, and have a negative pregnancy test at the last visit of AS0008.
    - Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active , up until 20 weeks after the last administration of IMP (anticipated 5 half lives).
    - El paciente o su representante legal firmará y fechará un consentimiento informado (CI) por escrito autorizado por una Junta de Revisión Institucional (JRI) o Comité de Ética Independiente (CEI).
    - Según el criterio del investigador, el paciente o representante legal se considerará fiable y capaz de cumplir el protocolo (p. ej.: capaz de entender y cumplimentar los cuestionarios), el programa de visitas o la administración de la medicación.
    - En opinión del investigador, se espera que el paciente se beneficie de la participación en un estudio de extensión abierto.
    - El paciente finalizó AS0008 sin presentar criterios de retirada.
    - Las mujeres deben haber pasado la menopausia, haber sido sometidas a esterilización permanente (p. ej.: ligadura de trompas, histerectomía o salpingectomía bilateral) o, si se encuentran en edad fértil (mantienen relaciones sexuales y pueden quedar embarazadas), deben estar dispuestas a emplear un método anticonceptivo eficaz hasta 20 semanas después de la última administración del medicamento en investigación y pasar una prueba de embarazo con resultado negativo en la última visita de AS0008.
    - Los hombres con pareja en edad fértil y sexualmente activos deben emplear preservativo hasta 20 semanas después de la última administración del medicamento en investigación (estimación, 5 semividas).
    E.4Principal exclusion criteria
    - Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of IMP. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose.
    - Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry.
    - Subjects who meet any withdrawal criteria in AS0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject’s entry into AS0009.
    - Las mujeres que deseen quedarse embarazadas durante el estudio o en las 20 semanas siguientes a la última administración del medicamento en investigación. Los hombres que tengan intención de tener un hijo durante el estudio o en las 20 semanas siguientes a la última administración.
    - Sujetos con cualquier signo o síntoma actual que pueda indicar una infección activa de interés clínico (salvo un resfriado común) o que hayan contraído alguna infección que haya requerido antibióticos sistémicos en las 2 semanas anteriores a la entrada en el estudio.
    - Sujetos que presenten algún criterio de retirada en AS0008. Si algún paciente presenta un AAG en curso o antecedentes de infecciones graves (como hospitalizaciones) en el estudio inicial, es necesario consultar al supervisor médico antes de incluirlo en AS0009.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of Adverse Event (AE) during the study
    2. Incidence of Serious Adverse Event (SAE) during the study
    1. Incidencia de Acontecimientos Adversos (AA) durante el estudio.
    2. Incidencia de Acontecimientos Adversos Graves (AAG) durante el estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. From Entry Visit (Visit 1) until Last Visit (up to Week 208)
    1-2. Desde la Visita de Entrada (Visita 1) hasta la última visita (hasta la semana 208)
    E.5.2Secondary end point(s)
    3. Subjects who withdrew due to an Adverse Event (AE) during the study
    4. Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to Baseline
    5. Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to AS0009 entry value
    6. Subjects with Axial Spondyloarthritis International Society 20% response criteria (ASAS20) at Week 48 calculated relative to Baseline
    7. Subjects with Axial Spondyloarthritis International Society 20% response criteria (ASAS20) at Week 48 calculated relative to AS0009 entry value
    8. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48
    9. Change from AS0009 entry value in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48
    3. Pacientes que se hayan retirado debido a un Acontecimiento Adverso (AA) durante el estudio.
    4. Pacientes con Valoración en la Sociedad Internacional de la Espondiloartritis Axial, respuesta del 40 % (ASAS40) en la semana 48 calculada en relación al valor inicial
    5. Pacientes con Valoración en la Sociedad Internacional de la Espondiloartritis Axial, respuesta del 40 % (ASAS40) en la semana 48 calculada en relación al valor de inscripción en el AS0009
    6. Pacientes con Valoración en la Sociedad Internacional de la Espondiloartritis Axial, respuesta del 20 % (ASAS20) en la semana 48 calculada en relación al valor inicial
    7. Pacientes con Valoración en la Sociedad Internacional de la Espondiloartritis Axial, respuesta del 20 % (ASAS20) en la semana 48 calculada en relación al valor de inscripción en el AS0009
    8. Cambio en la puntuación del Índice de Actividad de la Espondilitis Anquilosante de Bath (BASDAI) desde el valor inicial hasta la semana 48
    9. Cambio en la puntuación del Índice de Actividad de la Espondilitis Anquilosante de Bath (BASDAI) desde el valor de inscripción en el AS0009 hasta la semana 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    3: From Entry Visit (Visit 1) until Last Visit (up to Week 208)
    4, 6, 8: Baseline of AS0008, Week 48
    5, 7, 9: AS0009 Entry Visit, Week 48
    3: Desde la Visita de Entrada (Visita 1) hasta la última visita (hasta la semana 208)
    4, 6, 8: Valor inicial del AS0008, Semana 48
    5, 7, 9: Valor de inscripción del AS0009, Semana 48
    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 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 No
    E.8.1.1Randomised No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA70
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months7
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 285
    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)
    As soon as more data on safety and efficacy of bimekizumab become available, the current AS0009 study will either be amended to have a longer duration or the subjects completing this study may be transitioned to a different bimekizumab study as described in the protocol. In addition, there are other products already available that are approved for the same indication, therefore patients will not be without treatment alternatives once they are off of the bimekizumab study.
    Cuando se disponga de más datos sobre la seguridad y la eficacia del bimekizumab, o se modificará el actual estudio AS0009 para tener una duración más larga o los sujetos que lo completen pueden ser transicionados a un estudio diferente de bimekizumab como se describe en el protocolo. Además, hay otros productos aprobados ya disponibles para la misma indicación, por lo tanto los pacientes no estarán sin alternativas de tratamiento una vez que estén fuera del estudio de bimekizumab.
    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 Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
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