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    Summary
    EudraCT Number:2016-001102-42
    Sponsor's Protocol Code Number:AS0008
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-27
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-001102-42
    A.3Full title of the trial
    A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS
    ESTUDIO DE FASE IIB MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO,
    CONTROLADO CON PLACEBO, DE INTERVALOS DE DOSIS Y GRUPOS
    PARALELOS, PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE
    BIMEKIZUMAB EN PACIENTES CON ESPONDILITIS ANQUILOSANTE ACTIVA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.
    Un estudio multicéntrico para evaluar la eficacia y seguridad de diferentes
    dosis de bimekizumab en pacientes con espondilitis anquilosante activa
    que es una forma de artritis que afecta principalmente a la columna
    vertebral.
    A.4.1Sponsor's protocol code numberAS0008
    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 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 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
    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
    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 una forma 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 19.0
    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 dose-response based on the efficacy of bimekizumab
    Evaluar la relación dosis-respuesta basándose en la eficacia de
    bimekizumab
    E.2.2Secondary objectives of the trial
    - assess the efficacy of the individual dose regimens of bimekizumab compared to placebo
    - assess the safety and tolerability of bimekizumab
    - assess the pharmacokinetics (PK) of bimekizumab
    - assess the pharmacodynamics (PD) of bimekizumab
    - assess the immunogenicity of bimekizumab
    - assess the exposure: response relationship of bimekizumab as it relates to efficacy and safety
    -Evaluar la eficacia de cada una de las pautas posológicas de
    bimekizumab en comparación con placebo.
    -Evaluar la seguridad y tolerabilidad de bimekizumab.
    -Evaluar la FC de bimekizumab.
    -Evaluar la FD de bimekizumab.
    -Evaluar la inmunogenicidad de bimekizumab.
    -Evaluar la relación exposición-respuesta a bimekizumab a efectos de la
    eficacia y la seguridad.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A substudy will be initiated to asses genomic, genetic/epigenetic and proteomic variables. In a subpopulation MRIs will be taken for radiographic changes.
    Se empezará un subestudio para evaluar las variables
    genómicas,genéticas/epigenéticas y proteómicas. en una subpoblación
    se harán RMs para evaluar cambios radiográficos.
    E.3Principal inclusion criteria
    - Subject has active AS, determined by documented radiologic evidence fulfilling the Modified New York criteria for AS including symptoms for >=3 months and age of onset <45 years
    - Subject has moderate to severe active disease as defined by each of the following:
    --BASDAI score >=4
    --Spinal pain >=4 on a 0 to 10 NRS (from BASDAI item 2)
    - Subjects must have at least 1 of the following:
    -- inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy
    -- intolerance to administration of at least 1 NSAID
    -- contraindication(s) to NSAID therapy
    - Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their AS therapy are required to be on a stable dose for at least 14 days before Baseline
    - Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose up to Week 16
    - Subjects taking MTX (<=25mg/week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
    - Subjects taking sulfasalazine (up to 3grams/day) or hydroxychloroquine (up to 400mg per day total) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
    - Subjects may be TNF inhibitor-naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:
    --experienced an inadequate response to previous treatment given for at least 3 months
    -- been intolerant to administration (eg, had a side effect/AE that led to discontinuation)
    -- lost access to TNF inhibitor for other reasons
    -EA activa, determinada por signos radiológicos documentados
    (radiografía) que cumplen los criterios modificados de Nueva York para
    la EA (1984), incluyendo la presencia de síntomas durante un período ≥3
    meses y una edad al inicio de la enfermedad <45 años.
    -Enfermedad de actividad moderada a intensa, definida por cada una de
    las siguientes características:
     -Puntuación BASDAI ≥4.
     -Dolor en la columna vertebral ≥4 en la EVN del 0 al 10 (del ítem 2 en
    el índice BASDAI).
    -Presentar, como mínimo, 1 de las siguientes:
     -Respuesta insuficiente al tratamiento con AINE.
     -Intolerancia a la administración de al menos 1 AINE.
     -Contraindicación para el tratamiento con AINE.
    -Los pacientes que estén utilizando regularmente AINE/inhibidores de la
    COX-2 como parte de su tratamiento para la EA deben haber recibido una
    dosis estable durante un mínimo de 14 días antes de la visita basal
    -Los pacientes que estén utilizando corticoesteroides deben haber
    recibido una dosis diaria promedio de prednisona ≤10 mg/día
    oequivalente durante un mínimo de 14 días antes de la visita basal y
    seguir recibiendo una dosis estable hasta la semana 16.
    -Los pacientes que estén recibiendo MTX (≤25 mg/semana) pueden
    seguir haciéndolo, si la administración comenzó al menos 12 semanas
    antes de la visita basal y han estado recibiendo una dosis estable
    durante un mínimo de 8 semanas antes de la aleatorización.
    -Los pacientes que estén tomando sulfasalazina (máximo 3 mg/día) o
    hidroxicloroquina (máximo 400 mg/día en total) pueden seguir
    haciéndolo, si la administración comenzó al menos 12 semanas antes de
    la visita basal y han estado recibiendo una dosis estable durante un
    mínimo de 8 semanas antes de la aleatorización.
    -Pueden no haber recibido tratamiento previo con inhibidores del TNF o
    haber recibido previamente 1 inhibidor del TNF. Los pacientes que hayan
    recibido previamente un inhibidor del TNF deben:
     -haber tenido una respuesta insuficiente al tratamiento previo
    administrado durante al menos 3 meses,
     -ser intolerantes a la administración (p. ej., haber tenido un efecto
    secundario o AA que provocara la interrupción),
     -haber dejado de acceder al tratamiento inhibidor del TNF por otros
    motivos.
    E.4Principal exclusion criteria
    - Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg,rheumatoid arhritis (RA), sarcoidosis, systemic lupus erythematosus, or reactive arthritis
    - Subjects with any current sign or symptom that may indicate an active infection (except for the common cold)
    - Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
    - Subjects receiving any live vaccination within the 8 weeks prior to Baseline
    - Subjects with known tubercolosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection or current or history of nontuberculous mycobacteria (NTMB) infection
    - Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be indlucded:
    a) <= 3 excised or ablated basal cell carcinomas of the skin
    b) One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
    c) Actinic keratosis (-es)
    d) Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
    -Anquilosis total de la columna vertebral, o diagnóstico de cualquier otra
    artritis inflamatoria, p. ej., AR, sarcoidosis, lupus eritematoso sistémico
    o artritis reactiva.
    -Cualquier signo o síntoma en curso, indicativo de una infección activa
    (excepto resfriado común)
    -Antecedentes de infecciones crónicas o recurrentes, o infección grave o
    potencialmente mortal en los 6 meses anteriores a la visita basal
    -Recepción de alguna vacuna elaborada con microorganismos vivos
    (incluidas las vacunas atenuadas) en las 8 semanas previas a la visita
    basal
    -TB diagnosticada, riesgo alto de contraer TB, TB latente (TBL)*
    oinfección pasada o presente por MBNT.
    -Neoplasia maligna concurrente o antecedentes de neoplasia maligna
    (incluido carcinoma cervicouterino in situ resecado quirúrgicamente)
    durante los últimos 5 años, con las siguientes excepciones:
    a) Cifra ≤3 de carcinomas basocelulares de la piel eliminados por
    extirpación o ablación.
    b) Un carcinoma de la piel espinocelular (estadio T1 máximo) con
    extirpación o ablación satisfactoria solamente (otros tratamientos, es
    decir, la quimioterapia, no son aplicables), sin signos de recurrencia ni
    metástasis durante más de 2 años antes de la selección
    c) Queratosis actínica.
    d) Carcinoma espinocelular in situ de la piel con extirpación o ablación
    satisfactoria más de 6 meses antes de la selección.
    E.5 End points
    E.5.1Primary end point(s)
    Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 12
    Pacientes con uno 40 % de Criterio de Respuesta de la Sociedad
    Internacional para la Evaluación de las Espondiloartritis (Axial
    Spondyloarthritis International Society) (ASAS40) en la Semana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    - Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12
    - Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 12
    - Subjects with Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 12
    - Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
    - Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
    -Cambio desde el valor basal en la puntuación de actividad de la
    enfermedad ASDAS (Ankylosing Spondylitis Disease Activity Score)
    utilizando la PCR como reactivo de fase aguda (ASDAS-PCR) en la
    semana 12.
    -Pacientes con Respuesta ASAS20 en la semana 12.
    -Pacientes con Respuesta ASAS5/6 en la semana 12.
    -Cambio desde el valor basal en el índice de actividad de la enfermedad
    BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) en la
    semana 12.
    -Cambio desde el valor basal en el índice de actividad de la enfermedad
    BASFI (Bath Ankylosing Spondylitis Functional Index) en la semana 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline
    Week 12
    Basal
    Semana 12
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Bulgaria
    Canada
    Czech Republic
    Germany
    Hungary
    Poland
    Romania
    Russian Federation
    Spain
    Ukraine
    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
    Last Subject Last Visit
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 280
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 178
    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)
    Subjects completing this study will enter into an open-label study.
    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 Decision2016-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-30
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    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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