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    Summary
    EudraCT Number:2010-021259-22
    Sponsor's Protocol Code Number:TRX4_DM_008_WW_10
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-12-15
    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 number2010-021259-22
    A.3Full title of the trial
    Seguimiento a largo plazo del DEFEND-1: Evaluación del tratamiento de respuesta permanente para la diabetes Tipo 1 de inicio precoz o reciente. Estudio de extensión
    DEFEND-1 Long Term Follow Up: Durable-Response Therapy Evaluation for Early or New Onset Type 1 Diabetes Extension Study
    A.3.2Name or abbreviated title of the trial where available
    LTFU
    A.4.1Sponsor's protocol code numberTRX4_DM_008_WW_10
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTolerX, Inc.
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameOtelixizumab
    D.3.2Product code TRX4
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPRoute of administration not applicable
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNotelixizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    Otelixizumab ha sido desarrollado para el tratamiento de pacientes con DMT1 autoinmunitaria con función residual de las células beta, con el objetivo de preservar la función residual de las células beta en esta población de pacientes. Actualmente, no existen tratamientos curativos para la DMT1. En Estado Unidos, los tratamientos aprobados para DMT1 son insulina o análogos de la insulina. Otelixizumab is being developed for the treatment of patients with autoimmune T1DM with residual beta cell fu
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10012608
    E.1.2Term Diabetes mellitus insulin-dependent
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10012608
    E.1.2Term Diabetes mellitus dependiente de insulina
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar que los pacientes a los que se les administró una serie de infusiones de otelixizumab durante 8 días consecutivos en el DEFEND-1 experimentan una mejor preservación de la secreción endógena de insulina en comparación con los que recibieron placebo, como se evaluó mediante el área bajo la curva (ABC) de concentración-tiempo del péptido C estimulado con una comida mixta a los 48 meses tras la administración del fármaco en estudio.

    The primary objective is to demonstrate that subjects who received an 8 day series of otelixizumab infusions in DEFEND 1 have greater preservation of endogenous insulin secretion than subjects who received placebo, as assessed by area under the concentration-time curve (AUC) for mixed meal-stimulated C peptide, at 48 months after study drug administration.
    E.2.2Secondary objectives of the trial
    1.Comparar la secreción endógena de insulina, evaluada mediante el ABC del péptido C estimulado con una comida mixta a los 36 meses tras la administración del fármaco en estudio.
    2.Comparar el porcentaje de pacientes que responden, definido como los que tienen un valor de glicohemoglobina (HbA1c) 6,5% y un uso medio diario de insulina de < 0,5 UI/kg/día, entre los grupos de otelixizumab y de placebo.
    3.Evaluar el uso de insulina exógena en los grupos de otelixizumab y de placebo y en las sub-poblaciones seleccionadas.
    4.Evaluar el control de la glucemia, determinado por HbA1c y los episodios hipoglucémicos notificados por los pacientes, en los grupos de otelixizumab y de placebo en sub-poblaciones seleccionadas.
    5.Evaluar la seguridad a largo plazo de una serie de infusiones de otelixizumab durante 8 días consecutivos administradas en el DEFEND-1.

    The secondary Objectives are:
    1. To compare endogenous insulin secretion, as assessed by mixed meal-stimulated C peptide AUC, at
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Se incluirá a los sujetos solamente si cumplen todos los criterios siguientes.
    1. Incluidos anteriormente en el DEFEND-1.
    2. Completaron la Visita del Mes 24 del DEFEND-1; o, si se saltaron la Visita de Mes 24, han transcurrido al menos 24 meses desde la primera dosis del fármaco del estudio en el DEFEND-1.
    3. Ausencia de problemas que, a juicio del investigador, sea probable que hagan que el sujeto sea incapaz de comprender el formulario del asentimiento o el documento de consentimiento informado (DCI) o interfieran en la capacidad del sujeto de dar su asentimiento o consentimiento informado. Tales problemas incluirían, aunque no se reducen a, psicosis o retraso mental con un CI inferior a 65.
    4. Documento de consentimiento informado firmado por el sujeto si el sujeto es un adulto legalmente. Si el sujeto es un menor legalmente, el DCI firmado del padre/de la madre del sujeto, de ambos padres o de un tutor legal, y el formulario de asentimiento firmado por el sujeto, de acuerdo con las disposiciones legales y legislativas del país participante.
    5. Ausencia de problemas o situaciones que, a juicio del investigador, sea probable que hagan que el sujeto sea incapaz o carezca de la voluntad para participar en los procedimientos del estudio o para completar todas las valoraciones programadas. En Alemania, las personas ingresadas en alguna institución por orden oficial o judicial no son elegibles.

    Subjects will be enrolled only if they meet all of the following criteria.

    1. Previously enrolled in DEFEND-1.

    2. Completed the Month 24 visit of DEFEND 1; or, if the Month 24 visit was skipped, at least 24 months have elapsed since the first dose of study drug in DEFEND 1.

    3. No condition that, in the investigator?s judgment, is likely to cause the subject to be unable to understand the information in the assent form or Informed Consent Document (ICD) or interfere with the subject?s ability to provide assent or informed consent. Such conditions would include, but are not limited to, psychoses or mental retardation with an IQ below 65.

    4. Informed Consent Document signed by the subject if the subject is legally an adult. If the subject is legally a minor, ICD signed by the subject?s parent, both parents, or guardian and assent form signed by the subject, in accordance with the regulatory and legal requirements of the participating country.

    5. No condition or situation that, in the investigator?s judgment, is likely to cause the subject to be unable or unwilling to participate in study procedures or to complete all scheduled assessments. In Germany, persons who are confined to an institution by official or judicial order are not eligible.
    E.4Principal exclusion criteria
    Véase más arriba.
    E.5 End points
    E.5.1Primary end point(s)
    El cambio desde el inicio del DEFEND-1 en el ABC del péptido C estimulado con una comida mixta durante 2 horas en el mes 48. Este ABC se normalizará en cuanto al intervalo de tiempo al dividirla entre 120 minutos (la cantidad de minutos durante la cual se ha determinado, y se ajustará mediante la inclusión del ABC inicial del péptido C como una covariable del análisis.
    The primary efficacy endpoint is change from DEFEND-1 baseline in 2-hour mixed meal-stimulated C peptide AUC at Month 48. This AUC will be normalized for time interval by dividing it by 120 minutes (the number of minutes over which it is determined), and will be adjusted by inclusion of baseline C peptide AUC as a covariate in the analysis.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    Follow-up (extension) study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Follow-up (extension) study of TRX4_DM_007_EU_08
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    follow-up (extension) study of TRX4_DM_007_EU_08
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 Information not present in EudraCT
    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 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
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-12-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 272
    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 Decision2011-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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