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    Summary
    EudraCT Number:2016-001635-12
    Sponsor's Protocol Code Number:M15-562
    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:2018-05-10
    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 number2016-001635-12
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
    Estudio aleatorizado, doble ciego, controlado con placebo y de dosis múltiples para evaluar la eficacia, la seguridad, la tolerabilidad y la farmacocinética de ABBV-8E12 en la Parálisis Supranuclear Progresiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy, Safety , Tolerability and Pharmacokinetics of ABBV-8E12 in Subjects with Progressive Supranuclear Palsy.
    Estudio aleatorizado, doble ciego, controlado con placebo y de dosis múltiples para evaluar la eficacia, la seguridad, la tolerabilidad y la farmacocinética de ABBV-8E12 en la Parálisis Supranuclear Progresiva
    A.4.1Sponsor's protocol code numberM15-562
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02985879
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number34901200103
    B.5.6E-mailabbvie_reec@abbvie.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/239/15
    D.3 Description of the IMP
    D.3.2Product code ABBV-8E12
    D.3.4Pharmaceutical form 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 INNABBV-8E12
    D.3.9.2Current sponsor codeABBV-8E12
    D.3.9.3Other descriptive nameABBV-8E12
    D.3.9.4EV Substance CodeSUB183488
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized IgG4 anti-tau monoclonal antibody
    D.IMP: 2
    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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/239/15
    D.3 Description of the IMP
    D.3.2Product code ABBV-8E12
    D.3.4Pharmaceutical form 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 INNABBV-8E12
    D.3.9.2Current sponsor codeABBV-8E12
    D.3.9.3Other descriptive nameABBV-8E12
    D.3.9.4EV Substance CodeSUB183488
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized IgG4 anti-tau 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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Progressive Supranuclear Palsy
    Parálisis supranuclear progresiva
    E.1.1.1Medical condition in easily understood language
    PSP is a disease that attacks the brain, causing problems with body movement, memory, thinking, and behavior. Symptoms get worse over time and eventually make doing normal, daily tasks impossible.
    La PSP es una enf q ataca el cerebro y causa problemas relac con el movcorporal, la mem, el pmto y el comptto. Los sínts empeoran con el tiempo y hace q sea imposible realizar las tareas diarias norm.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10036813
    E.1.2Term Progressive supranuclear palsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the efficacy of ABBV-8E12 in slowing disease progression in subjects with progressive supranuclear palsy as measured by the PSP Rating Scale (PSP-RS).
    - To assess the long term safety and tolerability of ABBV-8E12 for up to 52 weeks in subjects with progressive supranuclear palsy.
    - Evaluar la eficacia de ABBV-8E12 en la ralentización de la progresión de la enfermedad en sujetos con parálisis supranuclear progresiva, medida por la Escala de Clasificación de PSP (PSP-RS).
    - Evaluar la seguridad y tolerabilidad a largo plazo de ABBV-8E12 durante 52 semanas en sujetos con parálisis supranuclear progresiva.
    E.2.2Secondary objectives of the trial
    - To assess the pharmacokinetics of ABBV-8E12 in subjects with PSP.
    - To assess the efficacy of ABBV-8E12 in slowing disease progression and functional impairment in subjects with PSP as measured by secondary endpoints.
    - To assess the efficacy of ABBV-8E12 in slowing regional and/or whole brain atrophy in subjects with PSP as measured by volumetric MRI.
    - Evaluar la farmacocinética de ABBV-8E12 en sujetos con PSP.
    - Evaluar la eficacia de ABBV-8E12 en la ralentización de la progresión de la enfermedad y el deterioro funcional en sujetos con PSP, medida por objetivos secundarios.
    - Evaluar la eficacia de ABBV-8E12 en la disminución de la atrofia cerebral regional y/o total en sujetos con PSP, medida por resonancia magnética volumétrica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female subject with age 40 years or greater at the time of signed consent.
    • Meets the following criteria for possible or probable progressive supranuclear palsy (Steele-Richardson-Olszewski Syndrome)
    - gradually progressive disorder, with age at disease onset greater than or equal to 40 years
    - either or both of the following two items are met:
    1. vertical supranuclear gaze palsy
    2. slowing of vertical saccades AND postural instability with falls within the first 3 years of PSP symptoms
    • Presence of PSP symptoms for less than 5 years.
    • Subject is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker).
    • Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).
    • Sujeto masculino o femenino con 40 años de edad o más en el momento de la firma del consentimiento informado
    • Cumple con los siguientes criterios para la posible o probable parálisis supranuclear progresiva (Síndrome de Steele-Richardson-Olszewski):
    - trastorno gradualmente progresivo, con edad mayor o igual a 40 años al inicio de la enfermedad
    - Que se cumplan uno o ambos de los siguientes elementos:
    1. parálisis supranuclear vertical de la mirada
    2. ralentización de los movimientos sacádicos verticales e inestabilidad postural con caídas dentro de los primeros 3 años de síntomas de PSP
    • Presencia de síntomas de PSP de menos de 5 años.
    • Sujeto que pueda caminar 5 pasos con asistencia mínima (estabilización de un brazo o uso de bastón/andador).
    • Sujeto que tenga un compañero de estudio identificado y de confianza (por ejemplo, un cuidador, un miembro de la familia, un trabajador social o un amigo).
    E.4Principal exclusion criteria
    • Subjects who weigh less than 44 kg (97 lbs) at screening.
    • MMSE score less than 15 at screening
    • Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
    • Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period.
    • Evidence of any clinically significant neurological disorder other than PSP
    • The subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria.
    • Subject has had a significant illness or infection requiring medical intervention in the past 30 days.
    • Sujetos que pesan menos de 44 kg (97 libras) en el periodo de selección
    • Puntuación de MMSE menor a 15 en el periodo de selección
    • Cualquier contraindicación o incapacidad para tolerar la resonancia magnética cerebral (RM)
    • Sujeto que reside en una institución de cuidados especializados de enfermería o demencia, o cuya admisión a dicha instalación esté planificada durante el período de estudio
    • Evidencia de cualquier trastorno neurológico clínicamente significativo que no sea PSP
    • Sujeto con un historial de esquizofrenia, trastorno esquizoafectivo o trastorno bipolar, o que lo padece actualmente, de acuerdo con los criterios DSM-V o ICD-10.
    • Sujeto ha tenido una enfermedad o infección importante que requirió intervención médica en los últimos 30 días.
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline to Week 52 on the PSP-RS total score.
    El cambio desde el inicio hasta la Semana 52 en la puntuación total de PSP-RS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 12, 24, 36 and 52
    Semanas 12, 24, 36 y 52
    E.5.2Secondary end point(s)
    1. To assess the pharmacokinetics of ABBV-8E12 in subjects with progressive supranuclear palsy.
    2. To assess the efficacy of ABBV-8E12 in slowing disease progression and functional impairment in subjects with progressive supranuclear palsy as measured by the SEADL, UPDRS Part II, CGI-S, CGI-C, and PSP-QoL.
    3. To assess the efficacy of ABBV-8E12 in slowing regional and/or whole brain atrophy in subjects with progressive supranuclear palsy as measured by volumetric MRI.
    1. Evaluar la farmacocinética de ABBV-8E12 en sujetos con parálisis supranuclear progresiva.
    2. Evaluar la eficacia de ABBV-8E12 en la ralentización de la progresión de la enfermedad y el deterioro funcional en sujetos con parálisis supranuclear progresiva medida por SEADL, UPDRS Parte II, CGI-S, CGI-C y PSP-QoL.
    3. Evaluar la eficacia de ABBV-8E12 en la ralentización de la atrofia cerebral regional y/o total en sujetos con parálisis supranuclear progresiva, medida por resonancia magnética volumétrica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 1, Day 5 (C1), Day 15, Day 29, Day 57 (C1), Day 85, Day 89 (C1), Day 99 (C1), Week 16 (C1), Week 24, Week 36, Week 52, Week 60, Week 68
    2. SEADL, UPDRS, – Screen, Day 1, Week 12, Week 24, Week 36, Week 52
    CGI-S-SV1, SV2, Day 1, Week 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 48 and Week 52
    CGI-C-Weeks 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 48 and Week 52
    PSP-QoL-SV1, Day 1, Week 12, Week 24, Week 36, Week 52
    3. Screen, Day 15 (C1), Week 12, Week 24, Week 52
    1. Día 1, Día 5 (C1), Día 15, Día 29, Día 57 (C1), Día 85, Día 89 (C1), Día 99 (C1), Semana 16 (C1), Semana 24, Semana 36, Semana 52, Semana 60, Semana 68
    2. SEADL, UPDRS, - Periodo de selección, Día 1, Semana 12, Semana 24, Semana 36, Semana 52
    CGI-S-SV1, SV2, Día 1, Semana 8, Semana 12, Semana 20, Semana 24, Semana 32, Semana 36, Semana 48 y Semana 52
    CGI-C-Semanas 8, Semana 12, Semana 20, Semana 24, Semana 32, Semana 36, Semana 48 y Semana 52
    PSP-QoL-SV1, Día 1, Semana 12, Semana 24, Semana 36, Semana 52
    3. Periodo de selección, Día 15 (C1), Semana 12, Semana 24, Semana 52
    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 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 No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Australia
    Canada
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days20
    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: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 238
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 330
    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)
    Possible Long Term Extension study or return to standard of care
    Posible estudio de extensión a largo plazo o regreso al tratamiento estándar
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CurePSP (Patient Advocacy)
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-07-01
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