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    Summary
    EudraCT Number:2016-004459-65
    Sponsor's Protocol Code Number:SEP-RES-2016-01
    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:2017-02-16
    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 number2016-004459-65
    A.3Full title of the trial
    Reslizumab in patients with severe asthma who failed to respond to omalizumab: a pilot study
    Estudio piloto de reslizumab en pacientes con asma grave que no han respondido a omalizumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reslizumab in patients with severe asthma who failed to respond to omalizumab
    Reslizumab en pacientes con asma grave que no han respondido a omalizumab
    A.4.1Sponsor's protocol code numberSEP-RES-2016-01
    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 SponsorRespira. Fundación Española del Pulmón (SEPAR)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTEVA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPICES
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street AddressAv. Antonio López, 16 - 1A
    B.5.3.2Town/ cityPinto (MADRID)
    B.5.3.3Post code28320
    B.5.3.4CountrySpain
    B.5.4Telephone number+34918166804103
    B.5.5Fax number+34918169172
    B.5.6E-mailjuanluis.sanz@apices.es
    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 Yes
    D.2.1.1.1Trade name CINQAERO
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameReslizumab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRESLIZUMAB
    D.3.9.1CAS number 241473-69-8
    D.3.9.3Other descriptive nameRESLIZUMAB
    D.3.9.4EV Substance CodeSUB96120
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 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
    Severe asthma
    Asma grave
    E.1.1.1Medical condition in easily understood language
    Severe asthma
    Asma grave
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of reslizumab (3mg/kg) administered every four weeks on asthma symptoms at week 24.
    Determinar el efecto de reslizumab (3 mg/kg) administrado cada cuatro semanas en los síntomas del asma en la semana 24.
    E.2.2Secondary objectives of the trial
    - Effect of reslizumab on asthma symptoms (ACQ-7 items) at week 24.
    - Effect of reslizumab on asthma symptoms (Asthma Control Test: ACT and ACQ-7 items) at weeks 4 and 12.
    - Effect of reslizumab on particular items of the ACT and ACQ-7 items (diurnal dyspnea, nocturnal awakenings, early morning symptoms, activity limitations, wheezing, use of rescue medication) at weeks 4, 12 and 24.
    - Effect of reslizumab on the rate of patients who achieve the minimally important difference of the ACT and ACQ at week 24.
    - Effect of reslizumab on peripheral eosinophil count at week 24.
    - Effect of reslizumab on pulmonary function (FEV1) at weeks 4, 12 and 24.
    - Effect of reslizumab on severe asthma exacerbations at week 24.
    - Effect of reslizumab on quality of life (assessed by AQLQ questionnaire) at weeks 4, 12 and 24.
    - Effect of reslizumab on exhaled nitric oxide levels at week 24.
    - Evaluation of adverse effects.
    - Efecto de reslizumab en los síntomas del asma mediante el Cuestionario ACQ de 7 items en la semana 24.
    - Efecto de reslizumab en los síntomas del asma (ACT y ACQ-7) en las semanas 4 y 12.
    - Efecto de reslizumab en determinados items del ACT y ACQ-7 (disnea, despertares, síntomas de madrugada, limitaciones de la actividad, sibilancias, medicación de rescate) en las semanas 4, 12 y 24.
    - Efecto de reslizumab sobre la tasa de pacientes que logran la mínima diferencia importante en la ACT y ACQ-7 en la semana 24.
    - Efecto de reslizumab en el recuento de eosinófilos en sangre periférica en la semana 24.
    - Efecto de reslizumab sobre la función pulmonar (FEV1) en las semanas 4, 12 y 24.
    - Efecto de reslizumab sobre las exacerbaciones graves del asma en la semana 24.
    - Efecto de reslizumab en la calidad de vida (AQLQ) en las semanas 4, 12 y 24.
    - Efecto de reslizumab en los niveles de óxido nítrico exhalado a las 24 semanas.
    - Evaluación de efectos adversos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Patients between 18 and 70 years of age,
    2- Patients diagnosed with severe uncontrolled asthma
    3- Patients who give informed consent.
    4- Previous treatment with omalizumab that was discontinued because lack of efficacy (symptoms –ACT < 20, exacerbations) or adverse effects. Omalizumab must have been used for at least a minimum of 16 weeks.
    5- Patients with a high blood eosinophil count (400 µl) at least once in the previous 3 years.
    6- Women should be surgically sterilized, at least 2 years have passed since menopause, or must have a negative pregnancy test within 7 days prior to initiation of treatment.
    7- Women of childbearing potential (not surgically sterilized or menopausal for less than 2 years) should use a medically accepted method of contraception and should agree to continue using this method during the study and at least 30 days after the end of the study.
    8- Patient should be willing and able to comply with the study restrictions and attend the visits indicated in the protocol to carry out the follow-up evaluations detailed in the protocol.
    1- Pacientes entre 18 y 70 años de edad
    2- Pacientes con diagnóstico de asma grave no controlado.
    3- Pacientes que otorguen su consentimiento informado.
    4- Tratamiento previo con omalizumab que se suspendió debido a la falta de eficacia (puntuación ACT < 20, exacerbaciones) o debido a efectos adversos. El paciente debe hacer recibido tratamiento previo con omalizumab durante al menos 16 semanas.
    5- Pacientes con un recuento de eosinófilos en sangre elevado (> 400 /µl) al menos una vez en los últimos 3 años o en la visita inicial.
    6- Las mujeres deben estar esterilizadas quirúrgicamente, deben haber transcurrido al menos 2 años desde la menopausia o deben tener una prueba de embarazo negativa en los 7 días previos al inicio del tratamiento.
    7- Las mujeres en edad fértil (no esterilizadas quirúrgicamente o que tienen la menopausia desde hace menos de 2 años), deben utilizar un método anticonceptivo médicamente aceptado y deben estar de acuerdo en continuar con el uso de este método durante el estudio y al menos 30 días después de la finalización del mismo.
    8- El paciente debe estar dispuesto y ser capaz de cumplir con las restricciones del estudio y acudir a las visitas indicadas en el protocolo para realizar las evaluaciones de seguimiento detalladas en el mismo.
    E.4Principal exclusion criteria
    1- Diagnosis of asthma-COPD overlap syndrome.
    2- Active and former smokers of> 10 packages / year.
    3- Exacerbations during the previous 4 weeks.
    4- Current treatment with omalizumab or last dose of omalizumab in the 5 months prior to inclusion of the patient in the study.
    5- Exposure to another monoclonal antibody.
    6- Participation in another clinical trial.
    7- Uncontrolled clinically significant disease, which may interfere with study procedures, interpretation of efficacy results, or compromise patient safety.
    8- Underlying lung disorder.
    9- Known hypereosinophilic syndrome.
    10- A pregnant or lactating woman, or who intends to become pregnant during the study.
    11- Participation in a clinical trial within 30 days prior to the start of treatment.
    12- Previous exposure to reslizumab or other anti-IL-5 monoclonal antibody.
    13- Immunodeficiency disorder, including HIV.
    14- Suspected drug or alcohol abuse.
    15- Active helminth parasite infection or for which treatment was received in the 6 months prior to the start of treatment.
    16- History of allergic reaction or hypersensitivity to any component of the study drug.
    1- Diagnóstico de Síndrome de solapamiento EPOC-asma.
    2- Fumadores activos y exfumadores de > 10 paquetes/año
    3- Exacerbaciones durante las 4 semanas previas.
    4- Tratamiento actual con omalizumab o última dosis de omalizumab en los 5 meses previos a la inclusión del paciente en el estudio.
    5- Exposición previa a otro anticuerpo monoclonal.
    6- Participación en otro ensayo clínico.
    7- Enfermedad clínicamente significativa no controlada, que pueda interferir con los procedimientos de estudio, la interpretación de los resultados de eficacia, o comprometer la seguridad del paciente.
    8- Trastorno pulmonar subyacente.
    9- Síndrome hipereosinofílico conocido.
    10- Mujer embarazada o en periodo de lactancia, o que tiene intención de quedarse embarazada durante el estudio.
    11- Participación en un ensayo clínico dentro de los 30 días previos al inicio del tratamiento.
    12- Exposición previa a reslizumab u otro anticuerpo monoclonal anti IL-5.
    13- Trastorno de inmunodeficiencia, incluido VIH.
    14- Sospecha de abuso de drogas o alcohol.
    15- Infección parasitaria helmíntica activa o para la que recibió tratamiento en los 6 meses previos al inicio del tratamiento.
    16- Historia de reacción alérgica o hipersensibilidad a cualquier componente del fármaco en estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in Asthma Control Test score (ACT) between baseline and week 24.
    Diferencia en la puntuación del Test de Control del Asma (ACT) entre la visita basal y la vista de la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    1- Difference in the score of Asthma Control Test (ACT) between baseline and weeks 4 and 12.
    2- Score difference of the 7-item Asthma Control Questionnaire (ACQ) between baseline and weeks 4, 12 and 24.
    3 - Difference in the ACT and ACQ-7 items related to daytime dyspnoea, nocturnal awakenings, early morning symptoms, activity limitations, wheezing and use of rescue medication at weeks 4, 12 and 24.
    4- Percentage of patients that achieve the minimally important difference in ACT and ACQ-7 at week 24 compared to the baseline.
    5- Difference in eosinophil count in peripheral blood at week 24 compared to baseline.
    6 - Difference in lung function (FEV1) at weeks 4, 12 and 24 compared to baseline.
    7- Number of severe exacerbations of asthma during the 24 weeks of the study.
    8- Difference in the AQLQ questionnaire score at weeks 4, 12 and 24 compared to baseline.
    9- Difference in exhaled nitric oxide levels between baseline and week 24.
    10- Number and percentage of patients who have each adverse event.
    1- Diferencia en la puntuación del Test de Control del Asma (ACT) entre la visita basal y las vistas de las semanas 4 y 12.
    2- Diferencia en la puntuación del Cuestionario de Control del Asma (ACQ) de 7 items entre la visita basal y las vistas de las semanas 4, 12 y 24.
    3- Diferencia en la puntuación de los items del ACT y ACQ-7 relacionados con disnea diurna, despertares nocturnos, síntomas de madrugada, limitaciones de la actividad, sibilancias y uso de medicación de rescate, en las semanas 4, 12 y 24.
    4- Porcentaje de pacientes que logran la mínima diferencia importante en la ACT y ACQ-7 en la semana 24 respecto a la visita basal.
    5- Diferencia en el recuento de eosinófilos en sangre periférica en la semana 24 respecto a la visita basal.
    6- Diferencia sobre la función pulmonar (FEV1) en las semanas 4, 12 y 24 respecto a la visita basal.
    7- Número de exacerbaciones graves del asma durante las 24 semanas del estudio.
    8- Diferencia en la puntuación del cuestionario AQLQ en las semanas 4, 12 y 24 respecto a la visita basal.
    9- Diferencia en los niveles de óxido nítrico exhalado entre la visita basal y la vista de la semana 24.
    10- Número y porcentaje de pacientes que tienen cada acontecimiento adverso.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- Week 12 y 24
    2- Week 4, 12 y 24
    3- Week 4, 12 y 24
    4- Week 24
    5- Week 24
    6- Week 4, 12 y 24
    7- Week 24
    8- Week 4, 12 y 24
    9- Week 24
    10- Every month
    1- Semana 12 y 24
    2- Semana 4, 12 y 24
    3- Semana 4, 12 y 24
    4- Semana 24
    5- Semana 24
    6- Semana 4, 12 y 24
    7- Semana 24
    8- Semana 4, 12 y 24
    9- Semana 24
    10- Cada mes
    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 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.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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    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: 25
    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 state30
    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)
    None
    Ninguno
    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 Decision2017-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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