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    Summary
    EudraCT Number:2020-004040-29
    Sponsor's Protocol Code Number:CY5031
    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:2021-06-21
    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 number2020-004040-29
    A.3Full title of the trial
    A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS).
    Ensayo de fase 3, multicéntrico, doble ciego, aleatorizado y controlado con placebo para evaluar la eficacia y la seguridad de Reldesemtiv en pacientes con Esclerosis Lateral Amiotrófica (ELA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested.
    Un estudio clínico en el que los pacientes diagnosticados con Esclerosis Lateral Amiotrófica (ELA) recibirán Reldesemtiv (fármaco del estudio). Se comprobará la seguridad y la eficacia del fármaco
    A.3.2Name or abbreviated title of the trial where available
    COURAGE-ALS
    COURAGE-ALS
    A.4.1Sponsor's protocol code numberCY5031
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/025/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCytokinetics 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 supportCytokinetics Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSERMES PLANIFICACION S.L
    B.5.2Functional name of contact pointSTART UP UNIT
    B.5.3 Address:
    B.5.3.1Street AddressCalle Rufino González, 14-2º D
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491327 50 25
    B.5.5Fax number+3491754 27 21
    B.5.6E-mailstart-up@sermescro.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 numberEU/3/20/2256
    D.3 Description of the IMP
    D.3.1Product namereldesemtiv
    D.3.2Product code CK-2127107
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNreldesemtiv
    D.3.9.1CAS number 1345410-31-2
    D.3.9.2Current sponsor codeCK-2127107
    D.3.9.3Other descriptive nameRELDESEMTIV
    D.3.9.4EV Substance CodeSUB191996
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Amyotrophic Lateral Sclerosis (ALS)
    Esclerosis Lateral Amiotrófica (ELA)
    E.1.1.1Medical condition in easily understood language
    ALS (also known Lou Gehrig’s disease or motor neuron disease) is a progressive and fatal degeneration of the nervous system.
    La ELA (también conocida como enfermedad de Lou Gehrig o enfermedad de las neuronas motoras) es una degeneración progresiva y mortal del sistema nervioso.
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    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 effect of reldesemtiv versus placebo on functional outcomes in ALS. To assess the safety and tolerability of reldesemtiv compared to placebo.
    Evaluar el efecto de reldesemtiv frente a placebo sobre los resultados funcionales en la ELA. Evaluar la seguridad y la tolerabilidad de reldesemtiv en comparación con el placebo.
    E.2.2Secondary objectives of the trial
    • To assess the effect of reldesemtiv versus placebo on combined functional and survival outcomes in ALS
    • To assess the effect of reldesemtiv versus placebo on ventilatory function
    • To assess the effect of reldesemtiv versus placebo on quality of life
    • To assess the effect of reldesemtiv versus placebo on handgrip strength

    Exploratory Objective
    To assess the effect of reldesemtiv versus
    placebo on the progression of ALS
    • Evaluar el efecto de reldesemtiv frente a placebo sobre los resultados funcionales y de supervivencia combinados en la ELA
    • Evaluar el efecto de reldesemtiv frente a placebo sobre la función respiratoria
    • Evaluar el efecto de reldesemtiv frente a placebo sobre la calidad de vida
    • Evaluar el efecto de reldesemtiv frente a placebo sobre la fuerza de prensión manual

    Objetivos exploratorios
    Evaluar el efecto de reldesemtiv frente a placebo sobre la progresión de la ELA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria
    • Males or Females between the ages of 18 and 80 years of age, inclusive
    • Diagnosis of familial or sporadic ALS (defined as meeting the laboratory-supported probable, probable, or definite criteria for ALS according to the World Federation of Neurology El Escorial criteria published in 2000 [Brooks 2000]). Patients who meet the possible criteria are eligible if they have lower motor neuron findings; those who have purely upper motor neuron findings are ineligible.
    • First symptom of ALS ≤ 24 months prior to screening. The qualifying first symptoms of ALS are limited to manifestations of weakness in extremity, bulbar, or respiratory muscles. Cramps, fasciculations, or fatigue should not be taken in isolation as a first symptom of ALS.
    • ALSFRS-R total score ≤ 44 at screening. Patients with a total score of 45 or higher may be rescreened 60±7 days following the original screening date and be deemed eligible if their ALSFRS-R total score is ≤ 44 or if their score is 2 or more points less than at initial screening.
    Such patients must continue to meet all other inclusion/exclusion criteria at the time of rescreening.
    • Upright FVC ≥ 65.0% of predicted for age, height, sex and ethnicity at screening according to Global Lung Initiative equation
    • Able to perform reproducible pulmonary function tests defined as being able to perform FVC at screening with variability of the 2 highest raw values of less than 10% with a maximum of 5 trials
    permitted. Screening FVC results must be reviewed and approved by the central review process prior to randomization.
    • Must be either on riluzole for ≥ 30 days prior to screening or have not taken it for at least 30 days prior to screening
    • Must have completed at least 2 cycles of edaravone at the time of screening or have not received it for at least 30 days prior to screening
    • Able to swallow whole tablets
    • Clinical laboratory findings within the normal range, or if outside the normal range, not deemed clinically significant by the Investigator, except as specifically indicated as laboratory exclusion
    Principales criterios de inclusión
    • Hombres o mujeres de entre 18 y 80 años de edad, inclusive.
    • Diagnóstico de ELA hereditaria o esporádica (definida como el cumplimiento de los criterios de ELA clínicamente probable con evidencia de laboratorio, ELA clínicamente probable o ELA definitiva según los criterios de El Escorial publicados por la Federación Mundial de Neurología el año 2000 [Brooks 2000]). Los pacientes que cumplen los criterios de ELA posible son elegibles si presentan disfunción de neurona motora inferior; los que solo presentan disfunción de neurona motora superior no son elegibles.
    • Primer síntoma de ELA ≤ 24 meses antes de la selección. Los primeros síntomas de ELA que se tendrán en cuenta se limitan manifestaciones de debilidad en los músculos de las extremidades, bulbares y respiratorios. Los calambres, las fasciculaciones o la fatiga no deben considerarse de forma aislada como un primer síntoma de ELA.
    • Puntuación total de la ALSFRS-R ≤ 44 en la selección. Los pacientes con una puntuación total de 45 o más pueden repetir el proceso de selección 60±7 días después de la fecha de selección original y pueden considerarse elegibles si su puntuación total de la ALSFRS-R es ≤ 44 o si su puntuación es 2 o más puntos inferior a la de la selección inicial.
    Estos pacientes deberán cumplir todos los demás criterios de inclusión/exclusión en el momento de repetir la selección.
    • CVF en posición erguida ≥ 65,0 % del valor previsto para la edad, estatura, sexo y origen étnico en la selección según la ecuación de la Iniciativa Global para la Función Pulmonar.
    • Capaz de efectuar pruebas de función pulmonar reproducibles, es decir, ser capaz de efectuar una prueba de CVF en la selección con una variabilidad de los 2 valores brutos más altos de menos del 10 % con un máximo de 5 intentos permitidos. Los resultados de la CVF de la selección deberán ser revisados y aprobados por el proceso de revisión central antes de la aleatorización.
    • Debe estar tomando riluzol durante ≥ 30 días antes de la selección o no haberlo tomado durante al menos 30 días antes de la selección.
    • Debe haber completado al menos 2 ciclos de edaravona en el momento de la selección o no haberla recibido durante al menos 30 días antes de la selección.
    • Capaz de tragar comprimidos enteros.
    • Resultados de los análisis clínicos dentro de los intervalos de normalidad, o si se encuentran fuera de rango, no ser considerados de importancia clínica por el Investigador, salvo si se indican específicamente como exclusión analítica.
    E.4Principal exclusion criteria
    • eGFRCysC < 45.0 mL/min/1.73 m2 at screening
    • Urine protein/creatinine ratio > 1 mg/mg (113 mg/mmol) at screening
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3-times the upper limit of normal (ULN)
    • Total bilirubin (TBL), direct or indirect bilirubin above the ULN.
    • Cognitive impairment, related to ALS or otherwise that impairs the patient’s ability to understand and/or comply with study procedures and provide informed consent
    • Other medically significant neurological conditions that could interfere with the assessment of ALS symptoms, signs or progression.
    • Presence at screening of any medically significant cardiac, pulmonary, gastrointestinal, musculoskeletal, or psychiatric illness that might interfere with the patient’s ability to comply with
    study procedures or that might confound the interpretation of clinical safety or efficacy data
    • Has a tracheostomy
    • VFGeCisC < 45,0 ml/min/1,73 m2 en la selección.
    • Proporción proteína-creatinina en orina > 1 mg/mg (113 mg/mmol) en la selección.
    • Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) ≥ 3 veces el límite superior de normalidad (LSN).
    • Bilirrubina total (BT), bilirrubina directa o indirecta por encima del LSN.
    • Deterioro cognitivo, relacionado con la ELA o que afecte la capacidad del paciente para comprender y/o cumplir con los procedimientos del estudio y otorgar su consentimiento informado.
    • Otras afecciones neurológicas de importancia médica que puedan interferir en la evaluación de los síntomas, signos y progresión de la ELA.
    • Presencia en la selección de cualquier enfermedad cardíaca, pulmonar, gastrointestinal, osteomuscular o psiquiátrica de importancia médica que pudiera interferir en la capacidad del paciente para cumplir con los procedimientos del estudio o que puedan confundir la interpretación de los datos de seguridad clínica o eficacia.
    • Tiene una traqueostomía.
    E.5 End points
    E.5.1Primary end point(s)
    • Change from baseline to Week 24 in ALSFRS-R total score.
    • Variación desde el inicio hasta la Semana 24 en la puntuación total de la ALSFRS-R.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    E.5.2Secondary end point(s)
    • Combined assessment of change in ALSFRS-R total score, time to onset of respiratory insufficiency, and survival time up to Week 24
    • Change from baseline to Week 24 in the percent predicted FVC
    • Change from baseline to Week 24 in the ALSAQ-40 total score
    • Change from baseline to Week 24 in handgrip strength (average of both hands)

    Exploratory Endpoints
    • Time to first receipt, time to first use, time to daily use, time to dependence and number used of any of the following durable medical equipment items (manual wheelchair, power wheelchair, augmentative and alternative communication device, noninvasive ventilation (NIV) and/or gastrostomy tube) from randomization to the end of the 24-week doubleblind, placebo-controlled period or to the end of the study
    • Change from baseline to Week 24 in the four subdomain scores of the ALSFRS-R
    • Time spent in each MiToS stage and number of patients to transition stages from baseline to Week 24
    • Change from baseline to Week 48 in ALSFRS-R total score
    • Change from baseline to Week 48 in forced vital capacity (FVC)
    • Combined assessment of change in ALSFRS-R total score, time to onset of respiratory insufficiency, and survival time up to Week 48
    • Change from baseline to Week 24 in the megascore of muscle strength measured by hand-held dynamometry (HHD) in bilateral first dorsal interosseous muscles, abductor pollicus brevis muscles, and abductor digiti minimi muscles
    • Change from baseline to Week 24 and Week 48 in the EQ-5D-5L
    • Change from baseline to Week 24 and Week 48 in the EQ-Visual Analogue Scale (VAS)
    • Evaluación combinada de la variación en la puntuación total de la ALSFRS-R, tiempo hasta el inicio de la insuficiencia respiratoria y tiempo de supervivencia hasta la Semana 24
    • Variación desde el inicio hasta la Semana 24 en la CVF porcentual prevista
    • Variación desde el inicio hasta la Semana 24 en la puntuación total del ALSAQ-40
    • Variación desde el inicio hasta la Semana 24 en la fuerza de prensión manual (promedio de ambas manos)

    Criterios de valoración Exploratorios
    • Tiempo hasta la primera recepción, tiempo hasta el primer uso, tiempo hasta el uso diario, tiempo hasta la dependencia y cantidad utilizada de cualquiera de los siguientes elementos de equipo médico duradero (silla de ruedas manual, silla de ruedas eléctrica, dispositivo de comunicación aumentativa y alternativa, ventilación no invasiva (VNI) y/o tubo de gastrostomía) desde la aleatorización hasta el final del periodo de 24 semanas doble ciego y controlado con placebo o hasta el final del estudio.
    • Variación desde el inicio hasta la Semana 24 en las puntuaciones de los cuatro subdominios de la ALSFRS-R.
    • Tiempo transcurrido en cada estadio Milano-Torino y número de pacientes que cambian de estadio desde el inicio hasta la Semana 24.
    • Variación desde el inicio hasta la Semana 48 en la puntuación total de la ALSFRS-R.
    • Variación desde el inicio hasta la Semana 48 en la capacidad vital forzada (CVF).
    • Evaluación combinada de la variación en la puntuación total de la ALSFRS-R, tiempo hasta el inicio de la insuficiencia respiratoria y tiempo de supervivencia hasta la Semana 48.
    • Variación desde el inicio hasta la Semana 24 en la megapuntuación de la fuerza muscular medida por dinamometría de mano (HHD) en los primeros músculos interóseos dorsales bilaterales, los músculos abductores pollicis brevis (abductor corto del pulgar) y los músculos abductores digiti minimi (abductor del meñique).
    • Variación desde el inicio hasta la Semana 24 y la Semana 48 en la EQ-5D-5L.
    • Variación desde el inicio hasta la Semana 24 y la Semana 48 en la EQ-Escala visual analógica (EVA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks for secondary objectives
    48 weeks for exploratory objectives
    24 semanas para los objetivos secundarios
    48 semanas para los objetivos exploratorios
    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 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) 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 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 trial2
    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 EEA24
    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
    Belgium
    France
    Germany
    Ireland
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months3
    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 months6
    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 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: 374
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 181
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 555
    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)
    Not yet determined
    Aún no determinado
    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 Decision2021-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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