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    Summary
    EudraCT Number:2018-001301-90
    Sponsor's Protocol Code Number:SNFCT2017-06
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-05-31
    Trial results View 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 number2018-001301-90
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When Added to Background Care for the Treatment of Calciphylaxis
    "Estudio en fase III, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de SNF472 cuando se añade al tratamiento de base para tratar la calcifilaxis"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess how safe and effective the study drug, SNF472, is when administered with background care for the treatment of calciphylaxis
    Un estudio para evaluar la seguridad y efectividad del medicamento del estudio, SNF472, cuando se administra con antecedentes para el tratamiento de la calcifilaxis
    A.4.1Sponsor's protocol code numberSNFCT2017-06
    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 SponsorSanifit Therapeutics S.A.
    B.1.3.4CountrySpain
    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 supportSanifit Therapeutics S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanifit Therapeutics S. A.
    B.5.2Functional name of contact pointSVP Development Operations
    B.5.3 Address:
    B.5.3.1Street Address3655 Nobel Dr. Suite 540
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92122
    B.5.3.4CountryUnited States
    B.5.4Telephone number+348589456542
    B.5.6E-mailclinical@sanifit.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 numberEU3/12/1026
    D.3 Description of the IMP
    D.3.2Product code SNF472
    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 INNSNF472
    D.3.9.1CAS number 34367-89-0
    D.3.9.3Other descriptive nameSNF472
    D.3.9.4EV Substance CodeSUB166954
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Calciphylaxis (calcific uremic arteriolopathy [CUA])
    Calcifilaxis (arteriolopatía urémica calcificada AUC
    E.1.1.1Medical condition in easily understood language
    Rare disease of calcification of the small blood vessels in the fatty tissue and deeper layers of the skin.
    Enfermedad rara de calcificación de los pequeños vasos sanguíneos en el tejido graso y las capas más profundas de la piel.
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    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
    • To evaluate the efficacy of SNF472 compared with placebo when added to background care for the treatment of CUA
    • To evaluate the safety and tolerability of SNF472 compared with placebo when added to background care for the treatment of CUA
    •Evaluar la eficacia de SNF472 en comparación con placebo cuando se añade al tratamiento de base para tratar la AUC
    •Evaluar la seguridad y la tolerabilidad de SNF472 en comparación con placebo cuando se añade al tratamiento de base para tratar la AUC
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥18 years of age
    2. Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening
    3. Clinical diagnosis of CUA by the Investigator including ≥1 CUA lesion with ulceration of
    the epithelial surface. A central wound rating group will review wound images to
    confirm the primary lesion is due to CUA.
    4. CUA wound-related pain shown by a Pain VAS score ≥50 out of 100
    5. Primary lesion that can be clearly photographed for the purpose of protocol-specified
    wound healing assessments
    6. Willing and able to understand and sign the informed consent form and willing to
    comply with all aspects of the protocol
    1.≥18 años de edad
    2.Recibir hemodiálisis de mantenimiento en un entorno clínico durante al menos 2 semanas antes de la selección
    3.Diagnóstico clínico de AUC por parte del Investigador que incluya ≥1 lesión de AUC con ulceración de la superficie epitelial. Un grupo central de valoración de heridas revisará las imágenes de la herida para confirmar que la lesión principal está causada por la AUC
    4.Dolor relacionado con heridas de AUC demostrado por una puntuación de EVA del dolor ≥50 de cada 100
    5.Lesión principal que se puede fotografiar claramente para llevar a cabo las evaluaciones de cicatrización de heridas especificadas en el protocolo
    6.Ser capaz de entender y estar dispuesto a firmar el formulario de consentimiento informado y estar dispuesto a cumplir con todos los aspectos del protocolo
    E.4Principal exclusion criteria
    1. Subjects whose primary lesion is due to causes other than CUA
    2. History of treatment with bisphosphonates within 3 months of baseline (Week 1 Day 1)
    3. Severely ill subjects without a reasonable expectation of survival for at least 6 months based on the assessment of the Investigator
    4. Subjects with a scheduled parathyroidectomy during the study period
    5. Expectation for kidney transplant within the next 6 months based on Investigator assessment or identification of a known living donor
    6. Pregnant or trying to become pregnant, currently breastfeeding, or of childbearing potential (including perimenopausal women who have had a menstrual period within one year) and not willing to either completely avoid sexual intercourse with a person of the opposite sex or use a highly effective method of birth control from screening through at least 30 days after last dose of study drug
    7. Significant noncompliance with dialysis treatment evidenced by repeated missed dialysis sessions (including if due to hospitalizations where dialysis treatment is unavailable) or significant noncompliance with medication regimen, in the judgment of the Investigator
    8. Any history of active malignancy within the last year (history of localized basal cell or squamous cell carcinoma that has been excised/appropriately treated or a fully excised malignant lesion with a low probability of recurrence will not be considered exclusionary)
    9. Clinically significant illness other than CUA within 30 days prior to screening that, in the judgment of the Investigator, could interfere with interpretation of study results, impair compliance with study procedures, or impact the safety of the subject (e.g., unstable angina, unstable heart failure, stroke, uncontrolled hypertension, or other illness requiring hospitalization)
    10. Participation in an investigational study and receipt of an investigational drug or investigational use of a licensed drug (with the exception of intravenous STS) within 30 days prior to screening. If participating in an investigational study of intravenous STS, all visits of that study must be completed prior to screening for this study. Note: Off-label use of intravenous STS outside of an investigational study is not restricted.
    11. Past or current participation in another clinical study with SNF472
    12. History or presence of active alcoholism or drug abuse as determined by the Investigator within 6 months before screening or concurrent social conditions that, in the opinion of the Investigator, would potentially interfere with the subject's study compliance
    13. Mental impairment or history of or current significant psychiatric disease that, in the opinion of the Investigator, may impair ability to provide informed consent or impact compliance with study procedures
    14. Any other condition or circumstance that, in the opinion of the Investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety and well-being
    15. Subjects whose CUA lesions exhibit significant improvement, in the opinion of the Investigator, between the first and second screening visit
    1.Sujetos cuya lesión principal se deba a causas distintas a la AUC
    2.Antecedentes de tratamiento con bifosfonatos en los 3 meses posteriores al inicio (día 1 de la semana 1)
    3.Sujetos gravemente enfermos sin una expectativa razonable de supervivencia durante al menos 6 meses según la evaluación del Investigador
    4.Sujetos con una paratiroidectomía programada durante el período del estudio
    5.Previsión de trasplante de riñón en los próximos 6 meses según la evaluación del Investigador o identificación de un donante vivo conocido
    6.Mujer embarazada o intentando quedarse embarazada, en período de lactancia o en edad fértil (incluidas las mujeres perimenopáusicas que hayan tenido un período menstrual en el plazo de un año) que no esté dispuesta a abstenerse por completo de mantener relaciones sexuales con una persona del sexo opuesto o a utilizar un método anticonceptivo altamente eficaz (especificados en la sección 4.7.4.2) desde la selección hasta al menos 30 días después de la última dosis del fármaco del estudio
    7.Incumplimiento significativo del tratamiento de diálisis demostrado por la repetición de sesiones de diálisis omitidas (incluso si se debe a hospitalizaciones en las que no se dispone de tratamiento de diálisis) o un incumplimiento significativo de la pauta de medicación, a criterio del Investigador
    8.Cualquier antecedente de neoplasia maligna activa en el último año (los antecedentes de carcinoma basocelular localizado o carcinoma epidermoide cutáneo que se haya extirpado o tratado de forma adecuada o una lesión maligna totalmente extirpada con una baja probabilidad de recaída no se consideran motivo de exclusión)
    9.Enfermedad clínicamente significativa distinta a la AUC en los 30 días anteriores a la selección que, en opinión del Investigador, pueda interferir en la interpretación de los resultados del estudio, deteriorar el cumplimiento de procedimientos del estudio o influir en la seguridad del sujeto (p. ej., angina de pecho inestable, insuficiencia cardíaca inestable, accidente cerebrovascular, hipertensión no controlada u otra enfermedad que requiera hospitalización)
    10.Participación en un estudio en investigación y recepción de un fármaco en investigación o uso en investigación de un fármaco aprobado (con la excepción de la administración intravenosa de STS) en los 30 días anteriores a la selección. Si participa en un estudio en investigación de administración intravenosa de STS, todas las visitas de ese estudio deben completarse antes de la selección de este estudio. Nota: No está limitado el uso intravenoso extraoficial de STS fuera de un estudio en investigación
    11.Participación actual o anterior en otro estudio clínico con SNF472
    12.Antecedentes o presencia de alcoholismo o abuso de drogas activos según lo determinado por el Investigador en un plazo de 6 meses antes de la selección o situaciones sociales simultáneas que, en opinión del Investigador, puedan interferir en el cumplimiento con el estudio por parte del sujeto
    13.Deterioro mental o antecedentes/presencia de enfermedad psiquiátrica significativa que, en opinión del Investigador, pueda afectar a la capacidad de otorgar consentimiento informado o al cumplimiento con los procedimientos del estudio
    14.Cualquier enfermedad o circunstancia que, a criterio del Investigador, pueda impedir que un sujeto complete el estudio o cumpla con los procedimientos y requisitos del estudio, o que suponga un riesgo para la seguridad y el bienestar del sujeto
    15.Sujetos cuyas lesiones de AUC muestren una mejoría significativa, en opinión del Investigador, entre la primera y la segunda visita de selección
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints; Applies to part 1.
    These endpoints will compare the placebo and SNF472 groups as follows;

    Alternate Primary Efficacy Endpoints:
    • Absolute change from baseline to Week 12 in the BWAT-CUA score for the primary lesion
    • Absolute change from baseline to Week 12 in Pain VAS score


    Safety Endpoints; Applies throughout part 1 and part 2
    • Proportion of subjects with AEs, SAEs, and deaths
    • Changes from baseline in the following:
    o Laboratory parameters
    o QTc interval and other ECG parameters
    o Holter monitoring results
    o Vital signs
    • Proportion of subjects with a CUA wound-related infection, sepsis, hospitalization, or any CUA wound-related complication
    Criterios de valoración, aplicados a la parte 1.
    Estos criterios compararán el grupo de placebo y el de SNF472 como se indica a continuación;
    Criterios de valoración principales de la eficacia alternativos:
    •Cambio absoluto desde el inicio hasta la semana 12 en la puntuación BWAT-AUC de la lesión principal
    •Cambio absoluto desde el inicio hasta la semana 12 en la puntuación de EVA del dolor

    Criterios de valoración aplicados a la parte 1 y parte 2
    •• Proporción de sujetos con AA, AAG y muertes
    •• Cambios desde el inicio en:
    • Parámetros analíticos
    • Intervalo QTc y otros parámetros del ECG
    • Resultados de monitorización del Holter
    •Constantes vitales
    •Proporción de sujetos con infección relacionada con heridas de AUC, septicemia, hospitalización o cualquier complicación relacionada con heridas de AUC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy (Part 1): Various timepoints from baseline to week 12
    Safety:
    Eficacia (Parte 1): varios puntos de tiempo desde el inicio hasta la semana 12
    La seguridad:
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints (assessed hierarchically):
    • Absolute change from baseline to Week 12 in the Wound-QoL score
    • Absolute change from baseline to Week 12 in the BWAT total score for the primary lesion
    • Qualitative wound image evaluation for the primary lesion (worsened, equal to, or improved relative to baseline) at Week 12
    • Rate of change in opioid use as measured in morphine milligram equivalents (MME) from baseline to Week 12
    Criterios de valoración secundarios de la eficacia (evaluados jerárquicamente):
    •Cambio absoluto desde el inicio hasta la semana 12 en la puntuación del cuestionario Wound-QoL
    •Cambio absoluto desde el inicio hasta la semana 12 en la puntuación total de BWAT de la lesión principal
    •Evaluación cualitativa de imágenes de heridas de la lesión principal (empeoraron, se mantuvieron igual o mejoraron con respecto al inicio) en la semana 12
    •Tasa de cambio en el uso de opioides medida en miligramos equivalentes de morfina (MME) desde el inicio hasta la semana 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints from baseline to week 12
    Varios puntos de tiempo desde el inicio hasta la semana 12
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned50
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Belgium
    France
    Germany
    Italy
    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
    LSLV
    LSLV
    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 months3
    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 months3
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 66
    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)
    Follow-Up Period/ Early Termination: Subjects completing the study will return for a follow-up
    visit 4 weeks after the last dose of study drug. Subjects should continue on stable background
    care during the 4-week follow-up period, including pain medication, with no changes unless
    medically indicated in the opinion of the Investigator.
    Período de seguimiento/finalización anticipada : los sujetos que completen el estudio volverán para una visita de seguimiento 4 semanas después de recibir la última dosis del fármaco del estudio. Los sujetos deben continuar con el tratamiento de base estable, incluidos los analgésicos, durante el período de seguimiento de 4 semanas. sin cambios, a menos que el Investigador indique lo contrario por razones médicas.
    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 Decision2020-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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