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    EudraCT Number:2013-003666-13
    Sponsor's Protocol Code Number:1311.8
    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:2013-10-24
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-003666-13
    A.3Full title of the trial
    A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis.
    Ensayo en fase II, aleatorizado, doble ciego, controlado con placebo de 48 semanas como prueba de concepto y de búsqueda de dosis de tres regímenes de dosificación diferentes de BI655066 administrados vía subcutánea en pacientes con espondilitis anquilosante.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BI 655066 proof of concept dose finding study in AS
    Estudio de prueba de concepto y búsqueda de dosis de BI 655066 en espondilitis anquilosante.
    A.3.2Name or abbreviated title of the trial where available
    BI 1311.8
    BI 1311.8
    A.4.1Sponsor's protocol code number1311.8
    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 SponsorBoehringer Ingelheim España, S.A.
    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 supportBoehringer Ingelheim España, S.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.4Telephone number+18002430127
    B.5.5Fax number+18008217119
    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 nameBI 655066 90 mg/ml
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeBI 655066
    D.3.9.3Other descriptive nameBI 655066
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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 Yes
    D. medicinal product typehumanized IgG monoclonal antibody
    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 in pre-filled syringe
    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
    Espondilitis anquilosante
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10002557
    E.1.2Term Ankylosing spondylitis and other inflammatory spondylopathies
    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
    Primary objective is to compare efficacy of BI 655066 versus placebo at 12 weeks, based on ASAS 40 response criteria.
    El objetivo principal es comparar la eficacia de BI 655066 frente a placebo a las 12 semanas a partir de los criterios de respuesta ASAS 40.
    E.2.2Secondary objectives of the trial
    To compare efficacy of BI 655066 versus placebo at 24 weeks, based on change in ASDAS score (key secondary)
    To compare efficacy of BI 655066 versus placebo at 24 weeks, based on ASAS 40 response criteria
    To compare efficacy of BI 655066 versus placebo at 24 weeks based on ASAS 20, ASAS 5/6, ASAS remission criteria, change in BASDAI score
    ? Comparar la eficacia de BI 655066 frente a placebo a las 24 semanas, a partir del cambio en la puntuación ASDAS (variable secundaria clave)
    ? Comparar la eficacia de BI 655066 frente a placebo a las 24 semanas a partir de los criterios de respuesta ASAS 40.
    ? Comparar la eficacia de BI 655066 frente a placebo a las 24 semanas a partir de los criterios ASAS 20, ASAS 5/6, criterios ASAS de remisión y el cambio en la puntuación BASDAI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female patients
    - Age >= 18 years and =< 70 years.
    - Definite AS based on the modified New York criteria (1984)
    - Documented disease duration >= 3 months at screening
    - Active disease at screening, defined as:
    a. BASDAI score (0-10) >= 4, AND
    b. Spinal pain level assessed by the 2nd BASDAI question (0-10) >= 4 (2nd question from BASDAI will be used here)
    - Have either a documented inadequate response for axial symptoms to 30 days of optimal daily doses of at least two non-steroidal anti-inflammatory drugs (NSAIDs), or documented intolerance to NSAIDs
    - Pacientes varones y mujeres.
    - Edad >= 18 años y <= 70 años.
    - Espondilitis anquilosante, definida según los criterios modificados de Nueva York (1984)
    - Duración justificada de la enfermedad >= 3 meses, en la selección.
    - Enfermedad activa en el momento de la selección, definida como:
    a. Puntuación BASDAI (0-10) >= 4, Y
    b. Evaluación del nivel de dolor espinal mediante la 2ª pregunta de BASDAI (0-10) >= 4
    - Presentar una respuesta insuficiente, confirmada de los síntomas axiales, a los 30 días de estar recibiendo dosis diarias óptimas de un mínimo de dos fármacos antiinflamatorios no esteroideos (NSAID) o tener una intolerancia confirmada a los NSAID.
    E.4Principal exclusion criteria
    - Radiographic evidence of total ankylosis of the spine at screening or before (spinal X-Ray examinations at screening visit/ during screening period are not mandatory - see footnote 12 from Flow-Chart 1).
    - Patient previously treated with any biological immunomodulating agent for AS, either licensed or experimental
    - Previous or current participation in a clinical trial testing an investigational drug for AS
    - Usage of any investigational drug within 30 days prior to randomization or the planned use of an investigational drug during the course of the actual study
    - Active uveitis or inflammatory bowel disease at screening
    - Diagnosed psoriatic arthritis at screening, satisfying the modified New York criteria
    - Patients who had received intraarticular injection(s) with corticosteroids within 4 weeks prior to screening visit
    - Prueba radiológica de anquilosis total de la columna, anterior a la selección o en ésta (no es obligatorio disponer de una radiografía de columna en la visita de selección ni durante el periodo de selección - véase la nota al pie, n.º 12 en el Diagrama de flujo 1).
    -. Paciente tratado previamente con algún inmunomodulador para la AS ya sea registrado o en fase de experimentación.
    - Participación anterior o en el presente en un ensayo clínico que pruebe un fármaco experimental para la AS.
    Uso de un fármaco en fase de investigación en los 30 días antes de la aleatorización o que esté previsto su uso durante el curso del presente ensayo.
    - Uveítis activa o enfermedad intestinal inflamatoria en el momento de la selección.
    - Artritis psoriásica en la selección diagnosticada , que cumpla los criterios modificados de Nueva York.
    - Pacientes que hayan recibido una o más inyecciones intraarticulares con corticoesteroides en las 4 semanas anteriores a la visita de selección.
    E.5 End points
    E.5.1Primary end point(s)
    1: ASAS 40 response
    1: respuesta ASAS 40
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: week 12
    1: semana 12
    E.5.2Secondary end point(s)
    1: Change in ASDAS score at Week 12 as compared to baseline (key secondary)
    2: ASAS 5/6 response
    3: ASAS remission criteria
    4: ASAS 20 response
    5: ASAS 40 response
    6: Change in BASDAI score as compared to baseline
    1: Cambio en la puntuación ASDAS en la semana 12 en comparación con el valor basal (variabla secundaria clave)
    2: Respuesta ASAS 5/6
    3: Criterios de remisión ASAS
    4: Respuesta ASAS 20
    5: Respuesta ASAS 40
    6: Cambio en la puntuación BASDAI en comparación con el valor basal
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: week 12

    2: week 12

    3: week 12

    4: week 12

    5: week 24

    6: week 12
    1: semana 12

    2: semana 12

    3: semana 12

    4: semana 12

    5: semana 24

    6: 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 Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 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. 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 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 Yes
    E. description
    Comparación de dosis
    Dose comparison
    E.8.2.4Number of treatment arms in the trial4
    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 EEA28
    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
    Hong Kong
    Korea, Republic of
    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
    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 months2
    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 months2
    E.8.9.2In all countries concerned by the trial days29
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 127
    F.4.2.2In the whole clinical trial 212
    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 Decision2013-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-25
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