Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-003856-19
    Sponsor's Protocol Code Number:LTS12551
    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:2014-03-21
    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 number2013-003856-19
    A.3Full title of the trial
    Open label extension study to evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in previous dupilumab asthma clinical study
    Estudio de extensión abierto para evaluar la seguridad y tolerabilidad a largo plazo de dupilumab, en pacientes con asma que participaron en el estudio clínico previo de dupilumab en asma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-Term Safety Evaluation of dupilumab in patients with asthma
    Evaluación de la seguridad a largo plazo de dupilumab en pacientes con asma
    A.4.1Sponsor's protocol code numberLTS12551
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1117-6745
    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 SponsorSanofi-aventis recherche et développement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis recherche et développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.5Fax numberNA
    B.5.6E-mailES-unidadestudiosclinicos@sanofi.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 nameDupilumab
    D.3.2Product code SAR231893
    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 INNDupilumab
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Asthma
    Asma
    E.1.1.1Medical condition in easily understood language
    Asthma
    Asma
    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 16.1
    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
    Evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in previous dupilumab asthma study ie DRI12544
    Evaluar la seguridad y tolerabilidad a largo plazo de dupilumab, en pacientes con asma que participaron en el estudio clínico previo de dupilumab en asma (esto es, DRI12544).
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study.
    - Evaluate dupilumab in patients with asthma who participated in previous dupilumab asthma clinical study, with regards to:
    * Systemic exposure
    * Anti-drug antibodies
    * Biomarkers
    Evaluar la eficacia de dupilumab en pacientes con asma que participaron en el estudio clínico previo de dupilumab en asma.
    Evaluar dupilumab en pacientes con asma que participaron en el estudio clínico previo de dupilumab en asma, en referencia a lo siguiente:
    ? Exposición sistémica
    ? Anticuerpos anti-fármaco
    ? Biomarcadores
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible patients who have completed a previous dupilumab asthma study (ie, DRI12544)
    Podrán ser incluidos en el estudio LTS12551, los pacientes aptos que hayan completado un estudio previo de dupilumab en asma (es decir, DRI12544)
    E.4Principal exclusion criteria
    - Patients who did not complete the previous dupilumab asthma study (entire study duration)
    - Patients who have experienced hypersensitivity reactions to dupilumab
    - Patients diagnosed with active parasitic infection; suspected or at high risk of parasitic infection, unless clinical and/or laboratoryassessments before randomization have ruled out an activeinfection
    - Medical history of human immunodeficiency virus (HIV) infection
    - Known or suspected medical history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution; or unusually frequent, recurrent or prolonged infections, as per investigator judgment
    - Evidence of acute or chronic infection requiring treatment with antibacterials, antivirals, antifungals, antiparasitics or antiprotozoals within 4 weeks before Visit 1; significant viral infections within 4 weeks before Visit 1 that may not have received antiviral treatment (eg, influenza receiving only symptomatic treatment)
    - Patients with any event or laboratory abnormality that, as per investigator judgment, would adversely affect participation of the patient in this study.
    - Patients who have traveled to parasitic endemic area within 6 months prior to screening.
    ? Pacientes que no hayan completado el estudio previo de dupilumab en asma (la duración total del estudio).
    ? Pacientes que han experimentado reacciones de hipersensibilidad a dupilumab.
    ? Diagnóstico de infección parasitaria activa; riesgo alto o sospecha de infección parasitaria, salvo que las evaluaciones clínicas y/o analíticas antes de la aleatorización hayan descartado una infección activa.
    ? Antecedentes médicos de infección por el virus de la inmunodeficiencia humana (VIH).
    ? Antecedentes médicos conocidos o sospecha de inmunosupresión, incluidos antecedentes de infecciones oportunistas invasivas (p. ej., tuberculosis, histoplasmosis, listeriosis, coccidioidomicosis, neumocistosis, aspergilosis), a pesar de la resolución de la infección; o infecciones recurrentes o prolongadas, inusualmente frecuentes, a criterio del investigador.
    ? Evidencia de infección aguda o crónica, que requiera un tratamiento con antibióticos, antivirales, antifúngicos, antiparasitarios o antiprotozoarios en un plazo de 4 semanas antes de la Visita 1; infecciones virales significativas en las 4 semanas antes de la Visita 1, que pudieron no haber recibido un tratamiento antiviral (p. ej., una gripe que tuvo solamente un tratamiento sintomático).
    ? Pacientes con cualquier acontecimiento o anomalía analítica que, a criterio del investigador, pudiera afectar negativamente a la participación del paciente en el estudio.
    ? Pacientes que hayan viajado a una zona de parasitosis endémica en los 6 meses previos a la selección.
    E.5 End points
    E.5.1Primary end point(s)
    Number of participants with adverse events
    Incidencia de acontecimientos adversos
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 112
    Semana 112
    E.5.2Secondary end point(s)
    1) Vital signs, Clinical laboratory tests, Electrocardiogram, Physical examination - clinically significant changes from baseline
    2) Forced expiratory volume in one second - clinically significant changes from baseline
    3) Asthma control questionnaire - clinically significant changes from baseline
    4) Asthma symptom scores - clinically significant changes from baseline
    5) Systemic exposure - changes from baseline
    6) Anti-drug antibodies - changes from baseline
    7) Biomarkers - changes from baseline
    1) Constantes vitales, Exploración física, Electrocardiograma (ECG), Pruebas clínicas de laboratorio - cambios clínicamente significativos desde la basal
    2) Volumen espiratorio forzado en un segundo (FEV1) - cambios clínicamente significativos desde la basal
    3) Cuestionario de control del asma (ACQ-5) - cambios clínicamente significativos desde la basal
    4) Puntuaciones de los síntomas del asma - cambios clínicamente significativos desde la basal
    5) Exposición sistémica - cambios desde la basal
    6) anticuerpos anti-fármacos - cambios desde la basal
    7) Biomarcadores - cambios desde la basal
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 6) Week 112
    7) Week 96
    1 a 6) Semana 112
    7) Semana 96
    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Japan
    New Zealand
    Argentina
    Australia
    Chile
    Korea, Republic of
    Mexico
    Russian Federation
    South Africa
    Turkey
    Ukraine
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days27
    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: 549
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 560
    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 Decision2014-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-11
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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.

    European Medicines Agency © 1995-Sat Apr 20 02:27:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA