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    Summary
    EudraCT Number:2022-002348-33
    Sponsor's Protocol Code Number:A35-011
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-17
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2022-002348-33
    A.3Full title of the trial
    A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX)
    Um estudo de extensão aberto de fase IIIb que avalia a segurança e tolerabilidade do AMX0035 até 108 semanas em participantes adultos com Esclerose Lateral Amiotrófica (ELA) anteriormente inscritos no estudo A35-004 (PHOENIX)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004
    Um estudo de extensão aberto de fase IIIb que avalia a segurança e tolerabilidade do AMX0035 até 108 semanas em participantes adultos com Esclerose Lateral Amiotrófica (ELA) anteriormente inscritos no estudo A35-004
    A.4.1Sponsor's protocol code numberA35-011
    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 SponsorAmylyx Pharmaceuticals 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 supportAmylyx Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD, part of Thermo Fisher Scientific
    B.5.2Functional name of contact pointProject Lead
    B.5.3 Address:
    B.5.3.1Street AddressAvenida da Liberdade, 180 A, 4° DT°
    B.5.3.2Town/ cityLisbon
    B.5.3.3Post code1250-146
    B.5.3.4CountryPortugal
    B.5.4Telephone number+35121350090400
    B.5.6E-mailcristina.oliveira@ppd.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/3/20/2284
    D.3 Description of the IMP
    D.3.2Product code AMX0035
    D.3.4Pharmaceutical form Oral powder
    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 INNPHENYLBUTYRATE
    D.3.9.1CAS number 1716-12-7
    D.3.9.3Other descriptive namePHENYLBUTYRATE
    D.3.9.4EV Substance CodeSUB127264
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUrsodoxicoltaurine
    D.3.9.1CAS number 14605-22-2
    D.3.9.3Other descriptive nametaurursodiol
    D.3.9.4EV Substance CodeSUB218624
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ALS (amyotrophic lateral sclerosis)
    ELA (Esclerose Lateral Amiotrófica)
    E.1.1.1Medical condition in easily understood language
    ALS
    ELA
    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 long-term safety and tolerability of treatment with AMX0035
    Avaliar a segurança e tolerabilidade do tratamento com AMX0035 a longo prazo
    E.2.2Secondary objectives of the trial
    To assess the impact of long-term treatment with AMX0035 on survival

    Exploratory: To assess the impact of long-term treatment with AMX0035 on measures of ALS function and key events in disease progression
    Avaliar o impacto do tratamento a longo prazo com AMX0035 na sobrevivência

    Exploratório: Avaliar o impacto do tratamento a longo prazo com AMX0035 nas medidas da função da ELA e principais eventos na progressão da doença
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Previous participation in Study A35-004 (PHOENIX), including completion of the randomized-controlled phase through Week 48 (this timepoint may be upcoming at the time of screening). Participants who do not complete randomized-controlled phase through Week 48 for medical reasons may be included on a case-by-case basis, in consultation with the sponsor;
    2. Capable of providing informed consent;
    3. Capable and willing to follow trial procedures including visits to the trial clinic, remote visits, and survival status reporting requirements;
    4. Women of childbearing potential (WOCBP; e.g., not post-menopausal for at least one year or surgically sterilea must agree to use adequate birth controlb for the duration of the trial and 3 months after the last dose of AMX0035;
    a. 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
    b. Acceptable contraception methods for use in this trial are:
    - Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants;
    - Barier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm);
    - Intrauterine device (IUD);
    - Abstinence (no heterosexual sex);
    - Unique partner who is surgically sterile (men) or not of childbearing potential (female).
    5. Women must not be pregnant or planning to become pregnant for the duration of the trial and 3 months after last dose of AMX0035;
    6. Men must agree to practice contraception for the duration of the trial and for at least 3 months after last dose of AMX0035;
    7. Men must not plan to father a child or to provide sperm for donation for the duration of the trial and 3 months after the last dose of AMX0035;
    1. Participação anterior no Estudo A35-004 (PHOENIX), incluindo a conclusão da fase aleatorizada controlada até à semana 48 (o momento da conclusão pode ser posterior ao momento da triagem).
    Os participantes que não concluam a fase aleatorizada controlada até à semana 48 por razões médicas podem ser incluídos com base numa avaliação caso a caso em consulta com o patrocinador;
    2. Capacidade de dar o seu consentimento informado;
    3. Capacidade e vontade de seguir os procedimentos do ensaio, incluindo as consultas no centro, consultas remotas e os requisitos de notificação do estado de sobrevivência;
    4. As mulheres férteis (MF) (p. ex., que não se encontrem na menopausa há pelo menos um ano, ou que não tenham sido submetidas a esterilização cirúrgicaa) devem concordar com a utilização de métodos contracetivos adequadosb durante o ensaio e
    até 3 meses após a última dose de AMX0035;
    a. 12 meses de amenorreia espontânea ou 6 meses de amenorreia espontânea com níveis séricos de FSH > 40 mIU/ml ou 6 semanas após ooforectomia bilateral, com ou sem histerectomia.
    b. Os métodos contracetivos de utilização aceitável no âmbito deste ensaio são:
    - Métodos hormonais, como pílulas, adesivos, injeções, anéis vaginais ou implantes anticoncecionais;
    - Métodos de barreira (como preservativos e diafragmas) utilizados com um espermicida (espuma, creme ou gel que mata os espermatozoides);
    - Dispositivo intrauterino (DIU);
    - Abstinência (ausência de relações sexuais heterossexuais);
    - Exclusividade com um parceiro (do sexo masculino) submetido a esterilização cirúrgica ou com uma parceira (do sexo feminino) sem potencial de engravidar.
    5. As mulheres não devem estar grávidas ou a planear engravidar no decorrer do ensaio e até 3 meses após a última dose de AMX0035;
    6. Os homens devem concordar com a utilização de contracetivos no decorrer do ensaio e, pelo menos, até 3 meses após a última dose de AMX0035;
    7. Os homens não devem planear ser pais ou doar esperma durante o período do ensaio e até 3 meses após a última dose de AMX0035;
    E.4Principal exclusion criteria
    1. History of known allergy to phenyl butyrate or bile salts;
    2. Abnormal liver function defined as bilirubin levels and/or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 5 times the upper limit of the normal (obtained within 12 weeks from first dose);
    3. Renal insufficiency as defined by eGFR <60 mL/min/1.73m2 normal (obtained within 12 weeks from first dose);
    4. Pregnant women or women currently breastfeeding;
    5. Current severe biliary disease which may result in the Investigator medical judgement in biliary obstruction including for example active cholecystitis, primary biliary cirrhosis, sclerosing cholangitis, gallbladder cancer, gangrene of the gallbladder, abscess of the gallbladder;
    6. History of Class III/IV heart failure (per New York Heart Association – NYHA);
    7. Participant under severe salt restriction where the added salt intake due to treatment would put the participant at risk, in the Investigator clinical judgment;
    8. Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent, according to Investigator judgment;
    9. Clinically significant unstable medical condition (other than ALS) (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, severe laboratory test anomaly or clinically significant electrocardiogram [ECG] changes) that would pose a risk to the participant if he/she were to participate in the trial, according to Investigator judgment;
    10. Currently enrolled in another trial (excluding Study A35-004 (PHOENIX)) involving use of an investigational therapy (or within 5 plasma half-lives) prior to first dose at Baseline Visit;
    11. Implantation of Diaphragm Pacing System (DPS);
    12. Currently or previously treated within the last 30 days (or 5 half-lives, whichever is longer) from first dose at the Baseline Visit or planned exposure during the treatment period to any prohibited medications listed in Section 6.7 of the protocol.
    1. Historial de alergia conhecida ao fenilbutirato ou a sais biliares;
    2. Função hepática anormal, definida como níveis de bilirrubina e/ou aspartato aminotransferase (AST) e/ou alanina aminotransferase (ALT) > 5 vezes o limite superior do normal (obtidos no espaço de 12 semanas antes da primeira dose);
    3. Insuficiência renal, definida por eGFR < 60 ml/min/1,73 m2 normal (valor obtido no período de 12 semanas antes da primeira dose);
    4. Mulheres grávidas ou mulheres que estejam atualmente a amamentar;
    5. Doença biliar grave atual que, mediante o parecer médico do investigador, possa originar obstrução biliar, incluindo, por exemplo, colecistite ativa, cirrose biliar primária, colangite esclerosante ou cancro, gangrena ou abcesso da vesícula biliar;
    6. Historial de insuficiência cardíaca de classe III/IV (de acordo com a New York Heart Association);
    7. Limitação rigorosa de sal, de tal modo que o consumo acrescido de sal associado ao tratamento possa pôr em risco o participante, segundo o parecer clínico do investigador;
    8. Presença de doença psiquiátrica instável, deficiência cognitiva, demência ou abuso de substâncias que possa, de acordo com a opinião do investigador, afetar a capacidade do participante de dar o seu consentimento informado;
    9. Condição médica instável de importância clínica (para além da ELA) (e.g., instabilidade cardiovascular, infeção sistémica, disfunção da tiroide não tratada, anomalia grave dos testes laboratoriais ou alterações clinicamente significativas do eletrocardiograma [ECG]) que possam pôr o participante em risco se participar no ensaio, de acordo com o juízo do investigador;
    10. Participação atual noutro ensaio (exceto o Estudo A35-004 [PHOENIX]) que envolva a utilização de um medicamento experimental (ou dentro de 5 semi-vidas plasmáticas) antes da primeira dose na consulta de avaliação inicial;
    11. Implantação de um pacemaker diafragmático;
    12. Tratamento com um dos medicamento proibidos, atualmente ou nos últimos 30 dias (ou 5 semi-vidas, consoante o que for mais longo), antes da primeira dose na consulta de avaliação inicial ou exposição planeada a qualquer um destes.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of all AEs; AEs leading to treatment discontinuation or study withdrawal, and all SAEs in participants treated with AMX0035
    Incidência de todas os efeitos adversos; efeitos adversos que levam à descontinuação do tratamento ou retirada do estudo, e todos os efeitos adversos nos participantes tratados com AMX0035
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 108 weeks of treatment and FU visit (28 days after end of treatment)
    Após 108 semanas de tratamento e visita da FU (28 dias após o fim do tratamento)
    E.5.2Secondary end point(s)
    1. Overall survival of all-cause mortality

    2. Ventilation free survival (defined as death, tracheostomy for respiratory distress or permanent non-invasive ventilation [>22 hours per day for 7 consecutive days])

    Exploratory:
    1. Change from baseline in ALSFRS-R score at Week 108
    2. To assess the incidence rate of the following significant ALS life-events over 108 weeks:
    a) Tracheostomy for assisted ventilation;
    b) Tracheostomy for management of secretions;
    c) Permanent Assisted Ventilation (PAV) [defined as >22 hours daily of mechanical ventilation for more than one week (7 days)]. The date of onset of PAV is the first day of the 7 days;
    d) Placement of feeding tube and clinically significant (i.e., requiring hospitalization or emergency department [ED] visit) complication/intervention (e.g., displacement, replacement, complications requiring surgical intervention);
    e) Placement of infusion port (in the subset of participants receiving concurrent IV edaravone) and clinically significant (i.e., requiring hospitalization or ED visit) complication/intervention (e.g., thrombosis, bleeding, infection, replacement);
    f) Incidence and duration of hospitalizations lasting more than 24 hours.
    1. Sobrevivência global da mortalidade por todas as causas
    2.Sobrevivência sem ventilação (delimitada pela morte, traqueostomia devido a dificuldade respiratória ou ventilação não invasiva permanente [>22 horas por dia durante 7 dias consecutivos])

    Exploratório:
    1. Alteração em relação à avaliação inicial da pontuação ALSFRS-R na semana 108
    2. Avaliar a taxa de incidência dos seguintes eventos de vida significativos da ELA ao longo de 108 semanas:
    a) Traqueostomia para ventilação assistida;
    b) Traqueostomia para a aspiração de secreções;
    c) Ventilação Assistida Permanente (VAP) (definida como ventilação mecânica >22 horas por dia, durante um período superior a uma semana [7 dias]). Deve considerar-se a data de início da VAP como o primeiro dos 7 dias;
    d) Colocação de sonda para alimentação com subsequente complicação/intervenção (como o respetivo deslocamento, substituição ou qualquer complicação que implique uma intervenção cirúrgica) de importância clínica (i.e., que exija a hospitalização ou a intervenção dos serviços de emergência);
    e) Colocação de uma via de acesso para perfusões (no subconjunto de participantes a receber edaravone IV em simultâneo) com subsequente complicação/intervenção (como trombose, hemorragia, infeção ou a respetiva substituição) de importância clínica (i.e., que exija a hospitalização ou uma visita às urgências);
    f) Incidência e duração das hospitalizações superior a 24 horas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 108 weeks of treatment and FU visit (28 days after end of treatment)
    Após 108 semanas de tratamento e visita da FU (28 dias após o fim do tratamento)
    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 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 Yes
    E.8.1.7.1Other trial design description
    extensão aberto
    Open-label extension (OLE)
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    United Kingdom
    United States
    Belgium
    France
    Germany
    Ireland
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    Sweden
    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
    The end of the trial will correspond to the last participant last EOT visit/phone contact per the trial schedule. Patients will be followed for their long-term survival status.
    O final do ensaio corresponderá à última visita EOT/ contacto telefónico do último participante, de acordo com o calendário do ensaio. Os pacientes serão seguidos para o seu estado de sobrevivência a longo prazo.
    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 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: 286
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 424
    F.4.2.2In the whole clinical trial 446
    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)
    Post trial, AMX0035 will be made available to participants completing the study period in accordance with each competent authority's regulatory guidance.
    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 Decision2023-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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