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    Summary
    EudraCT Number:2021-004174-64
    Sponsor's Protocol Code Number:DMX-200-301
    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:2021-12-22
    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 number2021-004174-64
    A.3Full title of the trial
    A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB)
    Estudio pivotal de fase III multicéntrico, aleatorizado, doble ciego y comparado con placebo sobre la eficacia y la seguridad de DMX-200 en pacientes con glomeruloesclerosis focal y segmentaria (GEFS) que estén en tratamiento con un antagonista de los receptores de la angiotensina II (ARA-II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis
    Eficacia y seguridad de DMX-200 en paciente con glomeruloesclerosis focal y segmentaria
    A.3.2Name or abbreviated title of the trial where available
    ACTION3
    ACTION3
    A.4.1Sponsor's protocol code numberDMX-200-301
    A.5.4Other Identifiers
    Name:US FDA PIND Number:Number:146154
    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 SponsorDimerix Bioscience Pty Ltd
    B.1.3.4CountryAustralia
    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 supportDimerix Bioscience Pty Ltd
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDimerix Bioscience Pty Ltd
    B.5.2Functional name of contact pointMercedes Salgueira Lazo
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Doctor Fedriani 3
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41009
    B.5.3.4CountrySpain
    B.5.4Telephone number+34671 569 602
    B.5.6E-mailmercedes.salgueira.sspa@juntadeandalucia.es
    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 numberEMA/OD/103/18
    D.3 Description of the IMP
    D.3.1Product nameRepagermanium
    D.3.2Product code DMX-200
    D.3.4Pharmaceutical form Capsule
    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 INNRepagermanium
    D.3.9.2Current sponsor codeDMX-200
    D.3.9.4EV Substance CodeSUB234202
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Focal segmental glomerulosclerosis
    Glomeruloesclerosis focal y segmentaria
    E.1.1.1Medical condition in easily understood language
    Focal segmental glomerulosclerosis
    Glomeruloesclerosis focal y segmentaria
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067757
    E.1.2Term Focal segmental glomerulosclerosis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10016832
    E.1.2Term Focal & segmental glomerulosclerosis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of DMX-200 in terms of urine PCR and eGFR slope in patients with FSGS who are receiving an ARB
    Evaluar la eficacia de DMX-200 en términos del cociente de P/C en orina y pendiente de TFGe en pacientes con GEFS en tratamiento con un ARA
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of treatment with DMX-200 in patients with FSGS who are receiving an ARB
    - To evaluate the effect of DMX-200 on kidney function parameters including proteinuria in patients with FSGS who are receiving an ARB
    - Evaluar la seguridad y tolerabilidad del tratamiento con DMX-200 en pacientes con GEFS en tratamiento con un ARA
    - Evaluar el efecto de DMX-200 en los parámetros de la función renal, incluida la proteinuria, en pacientes con GEFS en tratamiento con un ARA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    - A diagnosis of FSGS confirmed by kidney biopsy. NOTE: The biopsy can have been obtained at any time. Diagnosis of FSGS should be based on light microscopy with supportive findings on either electron microscopy or immunofluorescence analysis (preferably both) and the clinical history and disease course consistent with primary FSGS, genetic FSGS, or FSGS of undetermined cause.
    - Must be receiving a stable dose of an ARB (irbesartan, losartan, valsartan, candesartan, olmesartan medoxomil, or azilsartan medoxomil) at the maximal tolerated dose and ≥50% of the maximum recommended dose per the product label for 6 weeks prior to Screening, or willing to transition to this treatment during the Titration and Stabilization period.
    - If taking corticosteroids, the dosage must be stable for ≥4 weeks prior to Screening and during the Stabilization period, and patients must have no plan to change their treatment regimen during the study.
    - If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, or sodium-glucose co-transporter-2 inhibitors, the dose and regimen must be stable for ≥26 weeks prior to Screening and during the Stabilization period and patients must have no plan to change their treatment regimen during the study.
    - Urine protein/creatinine ratio (PCR) >1.5 g/g (>169.5 mg/mmol) or 24-hour total protein >1.5 g/day based on 24-hour urine collection during Screening.
    - Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at Screening and ≥25 mL/min/1.73 m2 at the Qualification visit (Week −1).
    - Seated blood pressure ≤160/100 mm Hg (mean of 3 values) at Screening and ≤140/90 mm Hg (mean of 3 values) at the Qualification visit (Week −1).
    - Body mass index ≤40 kg/m2 at Screening.
    Criterios clave de inclusión:
    - Diagnóstico de GEFS confirmado mediante biopsia de riñón. NOTA: La biopsia puede obtenerse en cualquier momento. El diagnóstico de GEFS debe basarse en estudios de microscopia óptica con hallazgos complementarios en análisis de microscopia electrónica o de inmunofluorescencia (preferiblemente ambos) y una anamnesis y evolución de la enfermedad coherentes con la GEFS primaria, la GEFS genética o la GEFS de causa indeterminada.
    - Deben estar en tratamiento estable con un ARA (irbesartán, losartán, valsartán, candesartán, olmesartán medoxomil o azilsartán medoxomil) con la dosis máxima tolerada y ≥50 % de la dosis máxima recomendada según la ficha técnica del producto durante 6 semanas antes de la selección, o dispuestos a cambiar a este tratamiento durante el periodo de ajuste de la dosis y estabilización.
    - Si el paciente toma corticoesteroides, la dosis debe ser estable durante >4 semanas antes de la selección y durante el periodo de estabilización; asimismo, los pacientes no deben tener previsto cambiar su pauta posológica durante el estudio.
    - Si el paciente toma antialdosterónicos, antagonistas de los receptores de mineralocorticoides, inhibidores directos de la renina o inhibidores del cotransportador de sodio-glucosa de tipo 2, la dosis y la pauta posológica deben ser estables durante >26 semanas antes de la selección y durante el periodo de estabilización, y los pacientes no deben tener previsto realizar cambios en su pauta posológica durante el estudio.
    - Cociente de proteína-creatinina (P/C) en orina >1,5 g/g (>169,5 mg/mmol) o proteína total de 24 horas >1,5 g/día, según la recogida de orina de 24 horas durante la selección.
    - Tasa de filtración glomerular estimada (TFGe) ≥30 ml/min/1,73 m2 en el momento de la selección y ≥25 ml/min/1,73 m2 durante la visita de cualificación (semana –1).
    - Tensión arterial en sedestación ≤160/100 mm Hg (media de 3 valores) en la selección y ≤140/90 mm Hg (media de 3 valores) durante la visita de cualificación (semana –1).
    - Índice de masa corporal ≤40 kg/m2 durante la selección.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    - Has FSGS secondary to another condition.
    - History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin >8%), or non-fasting blood glucose >10 mmol/L at Screening.
    - History of lymphoma, leukemia, or any active malignancy within the past 2 years (except for basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ that have been resected and with no evidence of metastatic disease).
    - History of jaundice, active hepatitis, or known hepatobiliary disease (except asymptomatic cholelithiasis).
    - Documented history of heart failure (New York Heart Association Class III/IV) or a major adverse cardiac event within 12 weeks prior to Screening.
    - Serum potassium levels >5.5 mmol/L at Screening.
    - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 × upper limit of normal at Screening.
    - Treatment with immunosuppressant biological drugs, calcineurin inhibitors, cyclophosphamide, azathioprine, or mycophenolate mofetil within 26 weeks prior to Screening
    - Patients with <80.0% compliance to ARB treatment during the Stabilization Period (Weeks −6 to −1) of the study, as confirmed at the Qualification visit.
    Criterios clave de exclusión:
    - Tener GEFS secundaria a otra afección.
    - Antecedentes de diabetes de tipo 1 o diabetes de tipo 2 no controlada (definida como glucohemoglobina >8 %) o glucemia en estado posprandial >10 mmol/l durante la selección.
    - Antecedentes de linfoma, leucemia o de cualquier neoplasia maligna activa en los últimos 2 años (excepto en el caso de un carcinoma basocelular o epidermoide de la piel o un carcinoma cervicouterino localizado que se hayan extirpado y sin signos de cáncer con metástasis).
    - Antecedentes de ictericia, hepatitis activa o enfermedad hepatobiliar conocida (excepto la colelitiasis asintomática).
    - Antecedentes documentados de insuficiencia cardíaca (clases III/IV de la Asociación Neoyorquina de Cardiología [New York Heart Association]) o de una complicación cardíaca grave en las 12 semanas previas a la selección.
    - Concentraciones de potasio en suero >5,5 mmol/l en el momento de la selección.
    - Alanina aminotransferasa (ALAT) y aspartato aminotransferasa (ASAT) >2 veces el límite superior de la normalidad durante la selección.
    - Tratamiento con fármacos inmunodepresores biológicos, inhibidores de la calcineurina, ciclofosfamida, azatioprina o micofenolato mofetilo en las 26 semanas previas a la selección.
    - Pacientes con un cumplimiento <80,0 % del tratamiento con ARA durante el periodo de estabilización (semanas –6 a –1) del estudio, según se confirme durante la visita de cualificación.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percent change in urine PCR (based on 24-hour urine collection) following treatment with DMX-200 compared with placebo
    2. Slope of eGFR following treatment with DMX-200 compared with placebo
    1. Cambio porcentual en el cociente de P/C en orina (basado en la recogida de orina de 24 horas) después del tratamiento con DMX-200 en comparación con el placebo
    2. • Pendiente de TFGe después del tratamiento con DMX-200 en comparación con el placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. from Baseline to Week 35
    2. from Baseline to Week 104
    1. desde el inicio hasta la Semana 35
    2. desde el inicio hasta la Semana 104
    E.5.2Secondary end point(s)
    1. Incidence and severity of AEs following treatment with DMX-200 compared with placebo
    2. Incidence of clinically significant changes in the safety profile of patients treated with DMX-200 compared with placebo, as measured by changes from baseline in clinical laboratory evaluations (hematology, coagulation, clinical chemistry, and urinalysis), ECGs, vital signs, and physical examinations
    3. Proportion of responders and non-responders following treatment with DMX-200 compared with placebo, defined as:
    - Complete response: 24-hour urine PCR reduction to <0.3 g/g [<33.9 mg/mmol]
    - Modified partial remission (FPRE): 24-hour urine PCR reduction ≥40% from Baseline and <1.5 g/g [<169.5 mg/mmol]
    - No response (failure to meet any response criteria)
    4. Proportion of patients on treatment with DMX 200 compared with placebo that meet a composite endpoint of worsening in kidney function, as defined by the onset of kidney failure (initiation of chronic dialysis, kidney transplantation, or a sustained eGFR of <15 mL/min/1.73 m2), a 30% decline in eGFR from Baseline, or death from kidney or cardiovascular causes
    1. Incidencia e intensidad de los AA después del tratamiento con DMX-200 en comparación con el placebo
    2. Incidencia de alteraciones de importancia clínica en el perfil de toxicidad de los pacientes tratados con DMX-200 en comparación con el tratamiento con placebo, según la medición de los cambios desde el inicio en las evaluaciones analíticas clínicas (hematología, coagulación, bioquímica clínica y análisis de orina), ECG, constantes vitales y exploraciones físicas
    3. Proporción de pacientes con respuesta favorable y sin respuesta al tratamiento después del tratamiento con DMX-200 en comparación con placebo, definida como:
    - Respuesta completa: reducción del cociente de P/C en orina de 24 horas a <0,3 g/g (<33,9 mg/mmol)
    - Remisión parcial modificada (CREG): reducción >40 % del cociente de P/C en orina de 24 horas con respecto al valor inicial y <1,5 g/g (<169,5 mg/mmol)
    - Sin respuesta (no cumple ninguno de los criterios de respuesta)
    4. Proporción de pacientes en tratamiento con DMX-200 en comparación con placebo que cumplen un criterio de valoración compuesto de empeoramiento de la función renal, definido como inicio de la insuficiencia renal (inicio de diálisis prolongada, trasplante renal o una TFGe constante <15 ml/min/1,73 m2), una disminución del 30 % en la TFGe desde el inicio o la muerte por causas renales o cardiovasculares
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 4. Throughout study duration
    De 1 a 4. Durante todo el 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 No
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Hong Kong
    Argentina
    Brazil
    Denmark
    Korea, Republic of
    New Zealand
    Spain
    Taiwan
    United Kingdom
    United States
    France
    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
    The end of the study is defined as the date of the last visit of the last patient in the study globally.
    El final del estudio se define como la fecha de la última visita del último paciente del estudio a nivel mundial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    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: 263
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 286
    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)
    Patients will not receive any additional treatment or medical care from the Sponsor after completion of the study because, until DMX-200 is approved for patients with FSGS, post-study care should not differ from what is normally expected for patients with FSGS. If the study progresses after the first IA, an open-label extension study may, at the Sponsor’s discretion, be offered to patients who have completed the study.
    Los pacientes no recibirán ningún tratamiento o atención médica adicional por parte del Promotor tras la finalización del estudio porque, hasta que se apruebe DMX-200 para pacientes con GEFS, la atención posterior al estudio no debe diferir de la que normalmente se espera para los pacientes con GEFS. Si el estudio progresa después de la primera IA, se puede ofrecer un estudio de extensión abierto, a discreción del Promotor, a los pacientes que hayan completado el estudio.
    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 Decision2022-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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