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    Summary
    EudraCT Number:2021-003907-16
    Sponsor's Protocol Code Number:SPIMD-301
    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:2022-01-25
    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 number2021-003907-16
    A.3Full title of the trial
    A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)
    Estudio de fase III aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de las inyecciones subcutáneas diarias de elamipretida en sujetos con enfermedad mitocondrial primaria causada por mutaciones patogénicas del ADN nuclear (EMPn)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)
    Ensayo para evaluar la eficacia y seguridad de inyecciones subcutáneas diarias de elamipretida en sujetos con enfermedad mitocondrial primaria causada por mutaciones patógenas del ADN nuclear (EMPn)
    A.4.1Sponsor's protocol code numberSPIMD-301
    A.5.4Other Identifiers
    Name:IND Number:Number:123,553
    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 SponsorStealth BioTherapeutics 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 supportStealth BioTherapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStealth BioTherapeutics Inc.
    B.5.2Functional name of contact pointHess Suh
    B.5.3 Address:
    B.5.3.1Street Address140 Kendrick Street, Building C-West
    B.5.3.2Town/ cityNeedham
    B.5.3.3Post codeMA02494
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617762-2522
    B.5.5Fax number+1617608-2796
    B.5.6E-mailhess.suh@stealthbt.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameElamipretide
    D.3.2Product code MTP-131
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNELAMIPRETIDE
    D.3.9.1CAS number 736992-21-5
    D.3.9.2Current sponsor codeMTP131, SS-31
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeSUB187808
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)
    Enfermedad mitocondrial primaria causada por mutaciones patógenas del ADN nuclear (EMPn)
    E.1.1.1Medical condition in easily understood language
    Mitochondrial Myopathy
    Miopatía Mitocondrial
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10010331
    E.1.2Term Congenital, familial and genetic disorders
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10052635
    E.1.2Term Cytoplasmic disorders congenital
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10052637
    E.1.2Term Genetic mitochondrial abnormalities NEC
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027710
    E.1.2Term Mitochondrial myopathy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 evaluate the effect of single daily SC administration of elamipretide for 48 weeks on the:
    − Distance walked (in meters) on the 6-Minute Walk Test (6MWT)
    • Evaluar el efecto de la administración única diaria por vía s.c. de elamipretida durante 48 semanas sobre:
    - Distancia recorrida (en metros) en la prueba de marcha de 6 minutos (6MWT)
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of single daily SC administration of elamipretide for 48 weeks as measured by changes in the:
    − Total time (in seconds) the Five-Times Sit-to-Stand Test (5XSST)
    − Total time (in seconds) the Triple Timed Up-and-Go Test (3TUG)
    − Patient Global Impression (PGI) of Change Scale

    • To evaluate the safety and tolerability of single daily SC doses of elamipretide administered for 48 weeks
    • Evaluar el efecto de la administración única diaria por vía s.c. de elamipretida durante 48 semanas, medida por los cambios en:
    - Tiempo total (en segundos) en la prueba de sentarse y levantarse cinco veces (5XSST)
    - Tiempo total (en segundos) en la prueba de levantarse y caminar cronometrada triple (3TUG)
    - Escala de impresión global de cambio comunicada por el paciente (PGI)

    • Evaluar la seguridad y tolerabilidad de dosis únicas diarias s.c. de elamipretida administradas durante 48 semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide a signed informed consent form (ICF) prior to participation in any trial-related procedures.
    2. Agrees and is able to adhere to the trial requirements for the length of the trial, including administration of assigned treatment.
    3. Is ≥18 years and ≤ 70 years of age at the time of screening.
    4. Diagnosed with nPMD with a predominant clinical manifestation of myopathy, which must include progressive external ophthalmoplegia (PEO) and exercise intolerance and/or skeletal muscle weakness, with genetic confirmation of either:
    a. Nuclear DNA mutation of the mitochondrial replisome (replisome related mutations), which include the following genes:
    - POLG 1/2
    - TWINKLE (C10ORF2)
    - TYMP
    - DGUOK
    - TK2
    - RRM2B
    - RNASEH1
    - SSBP
    - MGME1
    - DNA2
    - ANT1 (SLC25A4)
    - SUCLG1
    - SUCLA2
    - MPV17
    or
    b. Other pathogenic mutations specific to nuclear DNA.
    5. Women of childbearing potential must agree to use one of the following methods of birth control from the date they sign the ICF until 28 days after the last dose of IMP:
    a. Abstinence, when it is in line with the preferred and usual lifestyle of the subject. Subject agrees to use a highly effective method of contraception should they become sexually active.
    b. Relationships with male partners who have been surgically sterilized by vasectomy (the vasectomy procedure must have been conducted at least 60 days prior to the Screening Visit).
    c. Barrier method (e.g., condom or occlusive cap) with spermicidal foam/gel/film/cream AND either hormonal contraception (oral, implanted, or injectable) or an intrauterine device or system.
    Note: Non-childbearing potential is defined as surgical sterilization (e.g., bilateral oophorectomy, hysterectomy, or tubal ligation) or postmenopausal (defined as permanent cessation of menstruation for at least 12 consecutive months prior to the Screening Visit).
    6. Male subjects with female partners of childbearing potential must be willing to use a highly effective method of contraception from the date they sign the ICF until 28 days after the last dose of IMP.
    1. Está dispuesto y es capaz de proporcionar un formulario de consentimiento informado (FCI) firmado antes de la participación en cualquiera de los procedimientos relacionados con el ensayo.
    2. Está de acuerdo y es capaz de cumplir los requisitos del ensayo durante todo el ensayo, incluida la administración del tratamiento asignado.
    3. Tiene ≥18 años y ≤70 años en el momento de la selección.
    4. Diagnóstico de EPn con una manifestación clínica predominante de miopatía, que debe incluir oftalmoplejía externa progresiva (OEP) e intolerancia al ejercicio y/o debilidad musculoesquelética, con confirmación genética de cualquiera de ellas:
    a. Mutación del ADN nuclear del replisoma mitocondrial (mutación relacionada con el replisoma), que incluye los siguientes genes:
    - POLG 1/2
    - TWINKLE (C10ORF2)
    - TYMP
    - DGUOK
    - TK2
    - RRM2B
    - RNASEH1
    - SSBP
    - MGME1
    - DNA2
    - ANT1 (SLC25A4)
    - SUCLG1
    - SUCLA2
    - MPV17
    o
    b. Otras mutaciones patógenas específicas del ADN nuclear.
    5. Las mujeres potencialmente fértiles deben comprometerse a utilizar uno de los siguientes métodos anticonceptivos desde la fecha en que firmen el FCI hasta 28 días después de la última dosis de PEI:
    a. La abstinencia, cuando se ajusta al estilo de vida preferido y habitual de la paciente. La paciente acepta utilizar un método anticonceptivo muy eficaz en caso de que se convierta en sexualmente activa.
    b. Relaciones con parejas masculinas que hayan sido esterilizadas quirúrgicamente mediante vasectomía (el procedimiento de vasectomía debe haberse realizado al menos 60 días antes de la visita de selección).
    c. Método de barrera (por ejemplo, preservativo o capuchón oclusivo) con espuma/gel/película/crema espermicida Y anticoncepción hormonal (oral, implantada o inyectable) o un dispositivo o sistema intrauterino.
    Nota: Se define como potencialmente no fértil la esterilización quirúrgica (por ejemplo, ovariectomía bilateral, histerectomía o ligadura de trompas) o la posmenopausia (definida como el cese permanente de la menstruación durante al menos 12 meses consecutivos antes de la visita de selección).
    6. Los pacientes masculinos con parejas femeninas en edad fértil deben estar dispuestos a utilizar un método anticonceptivo de alta eficacia desde la fecha en que firmen el FCI hasta 28 días después de la última dosis del PEI.
    E.4Principal exclusion criteria
    1. Subject is unable to perform the 6MWT, 3TUG, or 5XSST functional tests. The use of a gait assist device is allowed; however, use should remain consistent for the entire duration of the trial.
    2. Female subjects who are pregnant, planning to become pregnant, or breastfeeding/lactating.
    3. Walks < 200 meters or > 450 meters during the 6MWT (Screening visit only).
    4. The estimated glomerular filtration rate (eGFR) is < 30 mL/min/1.73 m2, using the Modification of Diet in Renal Disease (MDRD) Study equation (Screening visit only).
    5. Subject has undergone an in-patient hospitalization within 30 days prior to screening or has a planned hospitalization or a surgical procedure during the trial, unless in the opinion of the Investigator it is concluded that it will not impact the outcome measurements of the trial.
    6. Subject has clinically significant respiratory disease and/or cardiac disease that would interfere with trial assessments, in the opinion of the Investigator.
    7. Subject has had any prior interventional cardiac procedure (e.g., cardiac catheterization, angioplasty/percutaneous coronary intervention, balloon valvuloplasty, etc.) within 3 months prior to screening.
    8. Subject has history of or current severe neurologic impairment, severe epilepsy, severe ataxia, or severe neuropathy that may interfere with their ability to complete all trial requirements, in the opinion of the Investigator.
    9. Active malignancy or any other cancer from which the subject has been disease-free for < 2 years. Localized squamous or non-invasive basal cell skin carcinomas are allowed, if appropriately treated prior to screening.
    10. Subject has had a solid organ transplant.
    11. Subject has been previously diagnosed with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
    12. Subject has a history of a systemic eosinophilic illness and/or an eosinophil count >1,000 cells x106/L at the Screening Visit.
    13. Subject is currently participating or has participated in an interventional clinical trial (i.e., investigational product or device, stem cell therapy, gene therapy) within 30 days prior to current trial; or is currently enrolled in a non-interventional clinical trial that, in the opinion of the Investigator, may be potentially confounding to the results of the current trial (e.g., exercise therapy trial).
    14. Subject has received elamipretide (MTP-131) within the past one year of the Screening Visit.
    15. Subject has a history of active substance abuse during the year prior, in the opinion of the Investigator.
    16. Subject has any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all trial assessments and requirements to the best of their ability.
    1. El paciente no puede realizar las pruebas funcionales 6MWT, 3TUG o 5XSST. Se permite el uso de un dispositivo de ayuda a la marcha; sin embargo, su uso debe ser constante durante todo el ensayo.
    2. Mujeres embarazadas, que tienen previsto quedarse embarazadas o que están en período de lactancia.
    3. Camina <200 metros o >450 metros durante la 6MWT (solo en la visita de selección).
    4. La tasa de filtración glomerular estimada (TFGe) es <30 ml/min/1,73 m2, utilizando la ecuación del estudio de modificación de la dieta en la nefropatía (MDRD) (solo en la visita de selección).
    5. El paciente ha estado hospitalizado en los 30 días anteriores a la selección o tiene prevista una hospitalización o una intervención quirúrgica durante el ensayo, a menos que en opinión del investigador se concluya que no afectará a las mediciones del resultado del ensayo.
    6. El paciente tiene una enfermedad respiratoria y/o cardíaca clínicamente significativa que podría interferir en las evaluaciones del ensayo, en opinión del investigador.
    7. El paciente se ha sometido a algún procedimiento cardíaco intervencionista previo (p. ej., cateterismo cardíaco, angioplastia/intervención coronaria percutánea, valvuloplastia con balón, etc.) en los 3 meses anteriores a la selección.
    8. El paciente tiene antecedentes o deterioro neurológico grave en la actualidad, epilepsia grave, ataxia grave o neuropatía grave que pueda interferir en su capacidad para cumplir todos los requisitos del ensayo, en opinión del investigador.
    9. Neoplasia maligna activa o cualquier otro tipo de cáncer en el que el paciente haya estado libre de enfermedad durante <2 años. Se permiten los carcinomas cutáneos escamosos localizados o basocelulares no invasivos, si se tratan adecuadamente antes de la selección.
    10. El paciente se ha sometido a un trasplante de órgano sólido.
    11. Al paciente se le ha diagnosticado previamente infección por el virus de la inmunodeficiencia humana (VIH), la hepatitis B o la hepatitis C.
    12. El paciente tiene antecedentes de una enfermedad eosinofílica sistémica y/o un recuento de eosinófilos >1000 células × 106/l en la visita de selección.
    13. El paciente está participando o ha participado en un ensayo clínico intervencionista (es decir, producto o dispositivo en investigación, terapia con células madre, terapia génica) en los 30 días anteriores al ensayo actual; o está actualmente inscrito en un ensayo clínico no intervencionista que, en opinión del investigador, puede inducir a confusión respecto a los resultados del ensayo actual (por ejemplo, ensayo de terapia de ejercicio).
    14. El paciente ha recibido elamipretida (MTP-131) en el año anterior a la visita de selección.
    15. El paciente tiene antecedentes de abuso del principio activo durante el año anterior, según la opinión del investigador.
    16. El paciente tiene alguna afección médica previa o actual que, a juicio del investigador, le impediría participar de manera segura y/o completar todas las evaluaciones y requisitos del ensayo de la mejor manera posible.
    E.5 End points
    E.5.1Primary end point(s)
    • To evaluate the effect of single daily SC doses of elamipretide administered for 48 weeks on the:
    − Distance walked (in meters) on the 6MWT
    • Evaluar el efecto de la administración única diaria por vía s.c. de elamipretida durante 48 semanas sobre:
    - Distancia recorrida (en metros) en la prueba de marcha de 6 minutos (6MWT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6MWT: At all clinical site visits (Screening; Day 1; Week 12; Week 24; Week 36; Week 48; EOT)
    6MWT: En todas las visitas al centro clínico (inclusión; día 1; semana 12; semana 24; semana 36; semana 48; Fin de estudio)
    E.5.2Secondary end point(s)
    • To evaluate the effect of single daily SC doses of elamipretide administered for 48 weeks on the:
    − Total time (in seconds) on the Five Times Sit-to-Stand Test (5XSST)
    − Total time (in seconds) on the Triple Timed Up-and-Go Test (3TUG)
    − Patient Global Impression of Change (PGI) of Change Scale
    • Evaluar el efecto de la administración única diaria por vía s.c. de elamipretida durante 48 semanas, medida por los cambios en:
    -Tiempo total (en segundos) en la prueba de sentarse y levantarse cinco veces (5XSST)
    -Tiempo total (en segundos) en la prueba de levantarse y caminar cronometrada triple (3TUG)
    -Escala de impresión global de cambio comunicada por el paciente (PGI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    3TUG, 5XSST, PGI Tests: At all study site visits (Screening; Day 1; Week 12; Week 24; Week 36; Week 48; EOT)
    3TUG, 5XSST, PGI Tests: En todas las visitas al centro clínico (inclusión; día 1; semana 12; semana 24; semana 36; semana 48; Fin de estudio)
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Biomarkers assessment etc.
    Tolerabilidad, evaluación de biomarcadores etc.
    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 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 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 EEA20
    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
    Denmark
    Finland
    Germany
    Hungary
    Italy
    Netherlands
    Norway
    Spain
    United Kingdom
    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
    Último Paciente última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days27
    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: 98
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 65
    F.4.2.2In the whole clinical trial 130
    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)
    At the Week 48 Visit, the subject and Investigator may determine if the subject will enroll in an expanded access program (EAP), if available.
    En la visita de la semana 48, el sujeto y el investigador pueden determinar si el sujeto se inscribirá en un programa de acceso expandido (PAE), si está disponible.
    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 Decision2022-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-09
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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