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    Summary
    EudraCT Number:2021-001831-17
    Sponsor's Protocol Code Number:MT-7117-A-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:2021-12-16
    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 number2021-001831-17
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-label, Long-term, Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
    Estudio de extensión de fase III, multicéntrico, sin enmascaramiento y a largo plazo para evaluar la seguridad y la tolerabilidad de dersimelagon oral (MT-7117) en pacientes con protoporfiria eritropoyética (PPE) o protoporfiria ligada al cromosoma X (PLX)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open label, long-term extension study to determine how safe and tolerable oral Dersimelagon is in subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
    Estudio de extensión, sin enmascaramiento y a largo plazo para determinar hasta qué punto es seguro y tolerable dersimelagon oral en pacientes con protoporfiria eritropoyética (PPE) o protoporfiria ligada al cromosoma X (PLX)
    A.4.1Sponsor's protocol code numberMT-7117-A-301
    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 SponsorMitsubishi Tanabe Pharma Development America (MTDA), 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 supportMitsubishi Tanabe Pharma Development America, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMitsubishi Tanabe Pharma Europe LTD (MTPE)
    B.5.2Functional name of contact pointAndy Bryson
    B.5.3 Address:
    B.5.3.1Street AddressDashwood House, 69 Old Broad Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC2M1QS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)20 7065 5035
    B.5.6E-mailabryson@mt-pharma-eu.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 nameDersimelagon
    D.3.2Product code MT-7117
    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 INNDersimelagon
    D.3.9.2Current sponsor codeMT-7117
    D.3.9.3Other descriptive nameMT-7117
    D.3.9.4EV Substance CodeSUB181965
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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
    Erythropoietic Protoporphyria or X-Linked Protoporphyria
    Protoporfiria eritropoyética o protoporfiria ligada al cromosoma X
    E.1.1.1Medical condition in easily understood language
    Erythropoietic Protoporphyria or X-Linked Protoporphyria
    Protoporfiria eritropoyética o protoporfiria ligada al cromosoma X
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10015289
    E.1.2Term Erythropoietic protoporphyria
    E.1.2System Organ Class 100000004850
    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 long-term safety and tolerability of oral dersimelagon.
    Evaluar la seguridad y la tolerabilidad a largo plazo de dersimelagon oral.
    E.2.2Secondary objectives of the trial
    Not Applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects provided written informed consent to participate. For adolescent subjects, both adolescent assent and parental consent will be provided.
    2. Subjects who complete MT-7117-G01 (complete through Week 58 [Visit 12])
    3. Subjects have a body weight of ≥30 kg.
    4. Subjects are willing and able to travel to the study sites for all scheduled visits.
    5. In the Investigator’s opinion, subject can understand the nature of the study and any risks involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements (including travel).
    6. Female subjects who are non-lactating and have a negative urine pregnancy test at baseline visit prior to receiving the first dose of study drug.
    7. Female subjects of childbearing potential and male subjects with partner of childbearing potential must agree to use 2 effective methods of contraception including barrier method (especially for female subjects, one method must be highly effective method) as described in Section 4.6.1.
    1. Pacientes que hayan proporcionado un consentimiento informado por escrito para su participación. Para los pacientes adolescentes, se proporcionará el asentimiento del adolescente y el consentimiento de los progenitores.
    2. Pacientes que completen el MT-7117-G01 (completado hasta la semana 58 [visita 12]).
    3. Pacientes con un peso corporal ≥30 kg.
    4. Pacientes que quieran y puedan desplazarse a los centros del estudio para realizar todas las visitas programadas.
    5. Según el criterio del investigador, el paciente debe poder comprender la naturaleza del estudio y cualquier riesgo que implique la participación, y estar dispuesto a cooperar y cumplir con las restricciones y los requisitos del protocolo (incluido el desplazamiento).
    6. Pacientes mujeres que no estén en periodo de lactancia y que obtengan un resultado negativo en una prueba de embarazo en orina en la visita inicial, antes de recibir la primera dosis del fármaco del estudio.
    7. Las pacientes mujeres en edad fértil y los varones con una pareja en edad fértil deberán acceder al uso de 2 métodos anticonceptivos eficaces, incluidos el método de barrera (especialmente para las pacientes mujeres, uno de los métodos deberá ser de alta eficacia), tal y como se describe en el apartado 4.6.1.
    E.4Principal exclusion criteria
    1. History or presence of photodermatoses other than EPP or XLP.
    2. Presence or history of any hepatobiliary disease at screening determined as clinically significant by the Investigator after the discussion with the Sponsor Medical Monitor.
    3. Subjects with AST, ALT, ALP ≥3.0 × upper limit of normal (ULN) or total bilirubin > 1.5 × ULN at Screening.
    4. Subjects with or having a history (in the last 2 years) of excessive alcohol intake in the opinion of the Investigator.
    5. History of melanoma.
    6. Presence of melanoma and/or lesions suspicious for melanoma at Screening.
    7. History of familial melanoma (defined as having 2 or more first-degree relatives, such as parents, sibling and/or child).
    8. Presence of squamous cell carcinoma, basal cell carcinoma, or other malignant skin lesions. Any suspicious lesions or nevi will be evaluated. If the suspicious lesion or nevi cannot be resolved through biopsy or excision, the subject will be excluded from the study.
    9. History or presence of psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation and/or safety of the subjects.
    10. Presence of clinically significant acute or chronic renal disease based upon the subject’s medical records including hemodialysis; an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 as calculated by the CKD-EPI creatinine equation (2009) for adults and by the Schwartz creatinine equation for adolescents (2009) (Section 16.2, Appendix 2). MDRD can be used for adults per local recommendations.
    11. Presence of any clinically significant disease or laboratory abnormality which, in the opinion of the Investigator, can interfere with the study objectives and/or safety of the subjects.
    12. Female subjects who are pregnant, lactating, or intending to become pregnant during the study.
    13. Treatment with phototherapy or afamelanotide within 3 months before baseline (Visit 2).
    14. Treatment with cimetidine or antioxidant agents at doses which, in the opinion of the Investigator, may affect study endpoints (including but not limited to beta-carotene, cysteine, pyridoxine) within 4 weeks before baseline (Visit 2).
    15. Chronic treatment with any scheduled analgesic agents including, but not limited to, opioids and opioid derivatives such as morphine, hydrocodone, oxycodone, fentanyl, or their combination with other unscheduled analgesics or non-steroidal anti-inflammatory drug (Percocet and Vicodin-like prescription drugs) within 4 weeks before baseline (Visit 2). Acute use of scheduled narcotics greater than 3 months prior to baseline, overthe- counter medications (OTCs), such as non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin for analgesia, or prior temporary use of scheduled agents within 3 months of baseline (Visit 2) are not excluded.
    16. Treatment with any drugs or supplements which, in the opinion of the Investigator, can interfere with the objectives of the study or safety of the subjects.
    17. Previous treatment with any investigational agent other than dersimelagon within 12 weeks before Screening OR 5 half-lives of the investigational product (whichever is longer).
    18. Using the following drugs (including but not limited to) within 1 week of baseline (Visit 2):
    a. Drugs known to be predominantly metabolized by cytochrome P450 (CYP) 3A4 with a narrow therapeutic index for which elevated plasma concentrations are associated with clinical safety concern or significant medical events.
    b. Drugs that are known substrates of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporting polypeptide (OATP)1B1, or OATP1B3 for which elevated plasma concentrations are associated with significant medical events.
    1. Antecedentes o presencia de fotodermatosis distintas de la PPE y la PLX.
    2. Presencia o antecedentes de cualquier enfermedad hepatobiliar en la selección considerada de trascendencia clínica por el investigador tras consultar con el monitor médico del promotor.
    3. Pacientes con AST, ALT y FA ≥3,0 veces por encima del límite superior de la normalidad (LSN) o bilirrubina total >1,5 veces por encima del LSN en la selección.
    4. Pacientes que tengan o hayan tenido antecedentes (en los últimos 2 años) de una ingesta excesiva de alcohol según el criterio del investigador.
    5. Antecedentes de melanoma.
    6. Presencia de melanoma o de lesiones sospechosas de melanoma en la selección.
    7. Antecedentes familiares de melanoma (definido como 2 o más parientes directos, es decir, progenitores, hermanos o hijos).
    8. Presencia de carcinoma epidermoide, carcinoma basocelular u otras lesiones cutáneas neoplásicas malignas. Se evaluará cualquier sospecha de lesión o nevo.
    Si la sospecha de lesión o nevo no se resuelve mediante biopsia o extirpación, el paciente será excluido del estudio.
    9. Antecedentes o presencia de enfermedad psiquiátrica considerada de trascendencia clínica según el criterio del investigador y que pudiera afectar a la evaluación del estudio o la seguridad de los pacientes.
    10. Presencia de nefropatía aguda o crónica de trascendencia clínica según la historia clínica del paciente, incluida hemodiálisis; una filtración glomerular estimada (FGe) <60 ml/min/1,73 m2 calculada con la ecuación CKD-EPI de la creatinina (2009) para los adultos y con la ecuación Schwartz de la creatinina (2009) para los adolescentes (apartado 16.2, apéndice 2). Se podrá usar la modificación de la dieta en la enfermedad renal (MDRD, Modification of Diet in Renal Disease) según las recomendaciones locales.
    11. Presencia de cualquier enfermedad u otra anomalía analítica de trascendencia clínica que, según el criterio del investigador, podría interferir con los objetivos del estudio o la seguridad de los pacientes.
    12. Pacientes mujeres que estén embarazadas, en periodo de lactancia o que tengan la intención de quedarse embarazadas durante el estudio.
    13. Tratamiento con fototerapia o afamelanotida en los 3 meses anteriores al inicio (vista 2).
    14. Tratamiento con cimetidina o sustancias antioxidantes a unas dosis que, según el criterio del investigador, podrían afectar a los criterios de valoración del estudio (entre otros, betacaroteno, cisteína o piridoxina) durante las 4 semanas anteriores al inicio (visita 2).
    15. Tratamiento crónico con cualquier sustancia analgésica pautada, entre otros, opiáceos y derivados de opiáceos como morfina, hidrocodona, oxicodona, fentanilo o su combinación con otros analgésicos no programados o fármacos antiinflamatorios no esteroideos (Percocet y fármacos de venta con receta similares a Vicodin) durante las 4 semanas anteriores al inicio (visita 2). No queda excluido el uso agudo de narcóticos programados durante más de 3 meses antes del inicio, medicamentos sin receta médica, como fármacos antiinflamatorios no esteroideos (AINE) o ácido acetilsalicílico para la analgesia, o el uso previo temporal de sustancias programadas durante los 3 meses anteriores al inicio (visita 2).
    16. Tratamiento con cualquier fármaco o suplemento que, según el criterio del investigador, pueda interferir con los objetivos del estudio o la seguridad de los pacientes.
    17. Tratamiento anterior con cualquier otro fármaco experimental que no sea dersimelagon durante las 12 semanas anteriores a la selección O BIEN 5 semividas del producto en investigación (lo que sea más largo).
    18. Uso de los siguientes fármacos (entre otros) durante la semana anterior al inicio (visita 2):
    a. Fármacos conocidos por ser principalmente metabolizados por el citocromo P450 (CYP) 3A4 con un índice terapéutico estrecho y para los cuales unas concentraciones plasmáticas elevadas se asocian con una preocupación por la seguridad clínica o acontecimientos médicos relevantes.
    b. Fármacos conocidos por ser sustratos de la glucoproteína-P (gpP), proteína de resistencia al cáncer de mama (PRCM), polipéptido transportador de aniones orgánicos (OATP)1B1 o OATP1B3 para los cuales unas concentraciones plasmáticas elevadas se asocian con acontecimientos médicos relevantes.
    E.5 End points
    E.5.1Primary end point(s)
    1. Treatment-emergent adverse events (TEAEs) (including serious adverse events [SAEs] and adverse events of special interest [AESIs]).
    2. Physical examination.
    3. Vital signs (blood pressure, respiratory rate, pulse rate, and body temperature).
    4. Clinical laboratory examinations (hematology, coagulation, biochemistry, and
    urinalysis), including liver function markers (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma glutamyl transpeptidase [GGT], alkaline phosphatase [ALP], direct and total bilirubin).
    5. 12-lead electrocardiogram (ECG) parameters.
    6. Nevi appearance (assessed by a dermatologist or other qualified site staff). Any nevi undergoing change of clinical concern during active treatment will be biopsied for follow up and evaluated by the central pathology lab.
    1. Acontecimientos adversos surgidos durante el tratamiento (AAST) (incluidos los acontecimientos adversos graves [AAG] y los acontecimientos adversos de interés especial [AAIE]).
    2. Exploración física.
    3. Constantes vitales (presión arterial, frecuencia respiratoria, pulso y temperatura corporal).
    4. Pruebas analíticas de laboratorio (hematología, coagulación, bioquímica y análisis de orina), incluidos los marcadores de la función hepática (aspartato-aminotransferasa [AST], alanina-aminotransferasa [ALT], γ-glutamil-transferasa [γ-GT], fosfatasa alcalina [FA] y bilirrubina directa y total).
    5. Parámetros del electrocardiograma (ECG) de 12 derivaciones.
    6. Aparición de nevos (evaluación por un dermatólogo u otro miembro cualificado del personal del centro). Cualquier nevo que experimente un cambio durante el tratamiento activo que sea preocupante a nivel clínico se deberá biopsiar para realizar un seguimiento y ser evaluado por el laboratorio central de anatomía patológica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    SAE & Clinical lab - at visit 1-8
    Physical examination & Vital signs - at visit 1,2,3,5 &7
    ECG - visit 1
    Nevi appearance - at visit 1,2,3,5,7,& 8
    AAG y análisis de laboratorio: visitas 1-8
    Exploración física y constantes vitales: visitas 1, 2, 3, 5 y 7
    ECG: vista 1
    Aspecto de los nevos: visitas 1, 2, 3, 5, 7 y 8
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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
    Estudio de extensión a largo plazo
    Long term extension study
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Canada
    Germany
    Japan
    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
    UVUP (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 months0
    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 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: 37
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 37
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 138
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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
    Adolescents
    Adolescentes
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 184
    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)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation American Porphyria Foundation
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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