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    Summary
    EudraCT Number:2020-004980-24
    Sponsor's Protocol Code Number:mRNA-3705-P101
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-11
    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 number2020-004980-24
    A.3Full title of the trial
    A Global, Phase 1/2, Open-Label, Dose Optimization Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of mRNA-3705 in Participants with Isolated Methylmalonic Acidemia Due to Methylmalonyl-CoA Mutase Deficiency
    Estudio fase 1/2, internacional, abierto y de optimización de la dosis para evaluar la seguridad, tolerabilidad, la farmacodinámica y la farmacocinética de mRNA-3705 en participantes con acidemia metilmalónica aislada por deficiencia de metilmalonil-CoA mutasa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate mRNA-3705 in Patients with MMA
    Ensayo clínico para evaluar mRNA-3705 en pacientes con AMM
    A.4.1Sponsor's protocol code numbermRNA-3705-P101
    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 SponsorModernaTX, 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 supportModernaTX, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationModernaTX, Inc.
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address200 Technology Square
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number1 617 209 5906
    B.5.6E-mailclinicaltrials@modernatx.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 number(EMA/OD/0000083787
    D.3 Description of the IMP
    D.3.1Product namemRNA-3705
    D.3.4Pharmaceutical form Solution for injection
    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 INNNA
    D.3.9.2Current sponsor codemRNA-3705
    D.3.9.3Other descriptive nameModified mRNA encoding human methylmalonyl-coenzyme A mutase
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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
    Isolated Methylmalonic Acidemia Due to Methylmalonyl-CoA Mutase Deficiency
    Acidemia metilmalónica aislada por deficiencia de metilmalonil-CoA mutasa
    E.1.1.1Medical condition in easily understood language
    Deficiency of the enzyme methylmalonyl-coenzyme A (CoA) mutase
    (MUT)
    Deficiencia en la enzima metilmalonil-coenzima A (CoA) mutasa (MUT)
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the safety and tolerability of mRNA-3705 administered via intravenous (IV) infusion to participants with isolated methylmalonic acidemia (MMA) due to methylmalonyl-coenzyme A mutase (MUT) deficiency.
    Determinar la seguridad y tolerabilidad de mRNA-3705 administrado en infusión intravenosa (IV) a participantes con acidemia metilmalónica (AMM) aislada por una carencia de metilmalonil-coenzima A mutasa (MUT).
    E.2.2Secondary objectives of the trial
    - Characterize the pharmacodynamic (PD) response to mRNA-3705 as determined by changes from baseline in plasma methylmalonic acid measurement after single and repeated administrations of mRNA-3705
    - Characterize the changes from baseline in plasma 2-methylcitric acid (2-MC) levels after single and repeated administrations of mRNA-3705
    - Characterize the pharmacokinetics (PK) of human MUT (hMUT) messenger ribonucleic acid (mRNA) after single and repeated administrations of mRNA-3705
    - Assess the presence and formation of anti-polyethylene glycol (PEG) antibodies (antidrug antibodies [ADAs])
    •Definir la respuesta farmacodinámica (FD) a mRNA-3705, determinada mediante las variaciones con respecto al momento basal de la concentración plasmática de ácido metilmalónico tras la administración única y repetida de mRNA-3705.
    •Definir las variaciones con respecto al momento basal de la concentración plasmática de ácido 2-metilcítrico (2-MC) tras la administración única y repetida de mRNA-3705.
    •Definir la farmacocinética (FC) del ácido ribonucleico mensajero (ARNm) de MUT humana (hMUT) tras la administración única y repetida de mRNA-3705
    •Evaluar la presencia y formación de anticuerpos antipolietilenglicol (PEG) (anticuerpos contra el fármaco [ACF]).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant is ≥ 1 year of age at the time of informed consent/assent.
    2. Participant has a body weight of ≥ 11.0 kg at the Screening Visit
    3. Participant has a diagnosis of isolated MMA due to MUT deficiency confirmed by molecular genetic testing. (see guidance in Section 8.1.1 for participants < 23.3 kg).
    4. Participant has a serum/plasma vitamin B12 level equal to or above the lower limit of normal (based on laboratory reference range) confirmed in the Screening Period. For those participants found to have an elevated serum/plasma vitamin B12 level, the participant may enter if, in the opinion of the Investigator, the cause of the elevation is secondary to B12 supplementation.
    5. Participant or his/her legally authorized representative is willing and able to provide informed consent and/or assent as mandated by local regulations and willing and able to comply with study-related assessments.
    6. Sexually active females of childbearing potential and
    sexually active males of reproductive potential agree to
    use a highly effective method of contraception during the study and for 3 months after the last administration of study drug (Section 11.4).
    7. Participants with parameters that indicate MMA clinical severity as described in Section 11.2.3.
    1.Edad ≥ 1 año en el momento de obtener el consentimiento /asentimiento informado.
    2.Peso corporal ≥ 11,0 kg en la visita de selección.
    3.Diagnóstico de AMM aislada por una carencia de MUT confirmada mediante un análisis de genética molecular (ver guía sección 8.1.1 por < 23.3 kg).
    4.Concentración sérica/plasmática de vitamina B12 de niveles iguales o superior al límite inferior normal (según el intervalo de referencia del laboratorio local) confirmada en el período de selección. Para aquellos pacientes con niveles elevados de B12 en suero/plasma, el paciente podría entrar en opnión del médico, si la causa de la elevación es secundaria al suplemento de B12.
    5.Disposición y capacidad del participante o de su representante legal para otorgar su consentimiento o asentimiento informado según lo exigido por la normativa local y para cumplir las evaluaciones relacionadas con el estudio.
    6.Compromiso por parte de las mujeres y los varones con capacidad reproductiva sexualmente activos de utilizar un método anticonceptivo muy eficaz durante el estudio y hasta tres meses después de recibir la
    última administración del fármaco del estudio (Sección 11.4).
    7. Pacientes con parámetros que indiquen severidad clínica de AMM como se describ en la sección 11.2.3
    E.4Principal exclusion criteria
    1. Participant has a diagnosis of isolated MMA cb1A, cb1B, or cb1D enzymatic subtypes or methylmalonyl-CoA
    epimerase deficiency or combined MMA with homocystinuria.
    2. Participant has any individual laboratory abnormalities achieving exclusionary thresholds defined in Table 16.
    3. Participant has previously received gene therapy for the treatment of MMA.
    4. Participant has an eGFR <30mL/min/1.73m2, as estimated by the Schwartz formula for participants<18years of age (Schwartz et al 2009), or by the Chronic Kidney Disease Epidemiology Collaboration creatinine-based formula for participants ≥ 18 years of age (Inker et al 2021), or receives long-term dialysis.
    5. Participant has a corrected QT interval > 480 ms using Bazett’s correction.
    6. For female participants of reproductive potential, the participant has a positive pregnancy test at the Screening
    Visit.
    7. Participant is pregnant or breastfeeding.
    8. Participant has a history of organ transplantation.
    9. Participant has a history of hypersensitivity to any components of the study drug.
    10. Participant has a history of hypersensitivity to
    acetaminophen/paracetamol and/or ibuprofen or
    H1/H2receptor blockers.
    11. Participation in another clinical study of another investigational agent within 30 days before study entry or within 5 elimination half-lives of the investigational agent, whichever is longer.
    12. Participant has undergone a major surgical procedure within 30 days before the Screening Visit (excludes central line, port, or feeding tube placement).
    13. Participant has new uses or adjustments in dose within the last 2 weeks to antibiotic therapy used to reduce propionate production. Any participant whose new or adjusted dose in antibiotics conflicts with the rules described above may enter the Treatment Period after stabilization of the antibiotic regimen and reconfirmation of study eligibility.
    14. Participant has an active, unstable or clinically significant medical condition not related to MMA or history of noncompliance that, in the Investigator’s opinion, could potentiate the risk while participating in this study, interfere with the interpretation of study results or limit
    the participant’s participation in the study. This may include, but is not limited to, history of relevant food or drug allergies; history of cardiovascular, central nervous, gastrointestinal, or infectious disease; history of clinically significant pathology; and/or history of cancer.
    15. Participant has received COVID-19 vaccination (generally 2 doses or a booster) within 6 weeks between their last COVID-19 vaccination dose and first study drug administration.
    16. Participant has any individual vital sign abnormalities achieving exclusionary thresholds as defined in Table 17
    17. Participant has a history of anaphylaxis/anaphylactoid reaction or severe hypersensitivity with infusions.
    1.Paciente con diagnóstico de AMM aislada por una carencia de metilmalonil-coA epimerasa o de los subtipos enzimáticos cb1A, cb1B o cb1D o de AMM combinada con homocistinuria.
    2. Paciente con alteración analítica que supere los límites de exclusión definidos en la Tabla 16.
    3.Paciente que haya recibido previamente terapia génica para tratar la AMM.
    4.Paciente con FGe < 30 ml/min/1,73 m2, calculada mediante la fórmula de Schwartz, o por la fórmula basada en creatinina de Chronic Kidney Disease Epidemiology Collaboration para participantes ≥ 18 años de edad (Inker et al 2021), o recibe diálisis a largo plazo.
    5.Pacinete con QT corregido > 480 ms con la corrección de Bazett.
    6.En el caso de las mujeres con capacidad reproductiva, prueba de embarazo positiva en la visita de selección.
    7.Mujer embarazada o en período de lactancia.
    8. Paciente con antecedentes de trasplante de órganos.
    9. Paciente con antecedentes de hipersensibilidad a cualquiera de los componentes del fármaco del estudio.
    10.Paciente con antecedentes de hipersensibilidad a paracetamol, ibuprofeno o antagonistas de los receptores H1/H2.
    11.Participación en otro estudio clínico de otro fármaco experimental en los 30 días previos a la incorporación al estudio o en el período equivalente a 5 semividas de eliminación del fármaco en investigación, lo que suponga más tiempo.
    12.Paciente que ha presentado una intervención de cirugía mayor en los 30 días previos a la visita de selección (excluida la colocación de una vía central, portal o sonda de alimentación).
    13. Paciente que tiene un nuevo ajustes de la dosis en las dos últimas semanas del tratamiento antibiótico utilizado para reducir la producción de propionato. Todo paciente cuya dosis nueva o ajustada de antibióticos entre en conflicto con las normas descritas anteriormente podrá incorporarse al período de tratamiento tras la estabilización del régimen antibiótico y una nueva confirmación de la elegibilidad para el estudio.
    14. El paciente tiene una condición médica activa, inestable o clínicamente significativa no relacionada con MMA o antecedentes de incumplimiento que, en opinión del investigador, podría potenciar el riesgo mientras participa en este estudio, interferir con la interpretación de los resultados del estudio o limitar la participación del paciente en el estudio. Esto puede incluir, entre otros, antecedentes de alergias a alimentos o medicamentos relevantes; antecedentes de enfermedades cardiovasculares, nerviosas centrales, gastrointestinales o infecciosas; antecedentes de patología clínicamente significativa; y/o antecedentes de cáncer.
    15. El paciente ha recibido la vacuna contra el COVID-19 (generalmente 2 dosis o un refuerzo) dentro de las 6 semanas entre su última dosis de vacunación contra el COVID-19 y la primera administración del fármaco del estudio.
    16. El paciente tiene anomalías individuales en los signos vitales que alcanzan los límites de exclusión como se define en la Tabla 17
    17. El paciente tiene antecedentes de anafilaxia/reacción anafilactoide o hipersensibilidad grave a las infusiones.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence and severity of TEAEs, including study drug-related and not related TEAEs, SAEs, and TEAEs leading to treatment discontinuation
    Incidencia y severidad de los acontecimientos adversos surgidos durante el tratamiento (AAST), incluidos los AAST relacionados y no relacionados con el fármaco del estudio, los acontecimientos adversos graves (AAG) y los AAST que motiven la suspensión del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoints will be evaluated over the entire period of the trial
    Los endpoints primarios serán evaluados durante todo el ensayo clínico.
    E.5.2Secondary end point(s)
    - Change in plasma methylmalonic acid levels from baseline (predose levels) to postdose levels measured after single and repeated administrations of mRNA-3705.
    - Estimation of PD parameters after single and repeated administrations of mRNA-3705, including maximum observed effect (Emax), area under the effect curve (AUEC), and duration of response.
    - Change in plasma 2-methylcitric acid (2-MC) levels from baseline (predose levels) to levels measured after single and repeated administrations of mRNA-3705.
    -Estimation of hMUT mRNA PK parameters including, but not limited to, maximum observed concentration (Cmax), time of Cmax (Tmax), , area under the concentration-time curve (AUC), terminal elimination half-life (t½), total body clearance (CL), and volume of distribution (Vz).
    - Presence and titers of anti-PEG antibodies
    •Variación de la concentración plasmática de ácido metilmalónico entre el momento basal (concentración previa a la administración) y momentos posteriores a la administración única y repetida de mRNA3705.
    •Estimación de parámetros farmacodinámicos tras la administración única y repetida de mRNA-3705, entre ellos, efecto máximo observado (Emáx), área bajo la curva de efecto (AUEC) y duración de la respuesta
    •Variación de la concentración plasmática de 2-MC entre el momento basal (concentración previa a la administración) y momentos posteriores a la administración única y repetida de mRNA-3705
    •Estimación de parámetros farmacocinéticos de ARNm de hMUT, entre ellos, concentración máxima observada (Cmáx), tiempo en alcanzar la Cmáx (Tmáx), área bajo la curva de concentración-tiempo (AUC), semivida de eliminación terminal (t½), aclaramiento corporal total (CL) y volumen de distribución (Vz)
    •Presencia y título de anticuerpos anti-PEG.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be evaluated over the entire period of the trial
    Los endpoints secundarios serán evaluados durante todo el ensayo clínico.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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 No
    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.8.3 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 EEA8
    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
    France
    Netherlands
    Spain
    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
    Ultima 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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 28
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 13
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 13
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Some patients may be below the age for giving consent and a legally
    authorized representative will provide informed consent and/or assent
    as mandated by local regulations
    Algunos pacientes pueden estar por debajo de la edad para dar su consentimiento y el
    representante legal autorizado proporcionará el consentimiento informado y/o asentimiento
    según lo exijan las normas locales
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 33
    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)
    Normal treatment or patients will transition to an extension study.
    El tratamiento normal o los pacientes pasarán a un estudio de extensión.
    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 Decision2023-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-08-18
    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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