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    Summary
    EudraCT Number:2018-000075-33
    Sponsor's Protocol Code Number:OMS721-IGA-001
    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:2018-05-21
    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 number2018-000075-33
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN)
    Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo de la seguridad y eficacia de OMS721 en pacientes con nefropatía por inmunoglobulina A (IgA) (ARTEMIS – IGAN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN)
    OMS721 en pacientes con nefropatía por inmunoglobulina A (IgA) (ARTEMIS – IGAN)
    A.3.2Name or abbreviated title of the trial where available
    ARTEMIS-IGAN
    A.4.1Sponsor's protocol code numberOMS721-IGA-001
    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 SponsorOmeros Corporation
    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 supportOmeros Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINC Research LLC
    B.5.2Functional name of contact pointAnita Burroughs
    B.5.3 Address:
    B.5.3.1Street Address3201 Beechleaf Court, Suite 600
    B.5.3.2Town/ cityRaleigh
    B.5.3.3Post codeNC 27609
    B.5.3.4CountryUnited States
    B.5.4Telephone number001919749-7949
    B.5.5Fax number001919749-7949
    B.5.6E-mailanita.burroughs@syneoshealth.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 numberEU/3/18/1984
    D.3 Description of the IMP
    D.3.2Product code OMS721
    D.3.4Pharmaceutical form Solution for infusion
    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 INNOMS721
    D.3.9.2Current sponsor codeOMS721
    D.3.9.3Other descriptive nameOMS721
    D.3.9.4EV Substance CodeSUB190278
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number370
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 infusion
    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
    IgA nephropathy (IgAN)
    Nefropatía por IgA (IgAN)
    E.1.1.1Medical condition in easily understood language
    Nephritis caused by deposition of antibodies in the kidneys
    Nefritis causada por deposición de anticuerpos en los riñones
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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 effect of OMS721 in patients with IgA nephropathy (IgAN) on proteinuria assessed by 24-hour urine protein excretion (UPE) in g/day at 24 weeks from beginning of treatment (BOT)
    • Evaluar el efecto del OMS721 en la proteinuria de pacientes con nefropatía por IgA (IgAN), según la evaluación de la excreción de proteínas en la orina (UPE) de 24 horas en g/día a las 24 semanas desde el inicio del tratamiento (BOT)
    E.2.2Secondary objectives of the trial
    To evaluate the effect of OMS721 in patients with IgAN on:
    •Safety and tolerability assessed by adverse events (AEs), vital signs, laboratory tests, and ECGs
    •Renal function as determined by the rate of change in eGFR up to 144 weeks from BOT
    •Proteinuria assessed by UPE at 24 weeks from BOT in the subset of patients with baseline high proteinuria (24-hour UPE ≥ 2 g/day)
    •Per-protocol-defined responder at 24 weeks
    •Per-protocol-defined partial-responder at 24 weeks
    •Time-averaged change in urine protein/creatinine ratio
    •Proportion of patients who achieve partial proteinuria remission (24-hour UPE < 0.6 g/day)
    •Proportion of patients who achieve complete proteinuria remission (24-hour UPE < 0.3 g/day)
    •Proportion of patients who received rescue therapy for IgAN at any time during the study
    •Pharmacokinetics, pharmacodynamics, and immunogenicity of OMS721
    Evaluar el efecto de OMS721 en pacientes con IgAN en:
    •Seguridad y tolerabilidad evaluados según eventos adversos, signos vitales, análisis de laboratorio y ECGs.
    •Función renal, determinada por tasa de cambio de eGFR hasta 144 semanas después del BOT.
    •Proteinuria, evaluada por UPE 24 semanas después del BOT en el subgrupo de pacientes con valor basal de proteinuria alto (UPE 24 horas ≥2 g/día).
    •Respondedores a tratamiento según protocolo a las 24 semanas.
    •Respondedores parciales a tratamiento según protocolo a las 24 semanas.
    •Cambio ponderado en el tiempo en el cociente proteína/creatinina en orina.
    •Proporción de pacientes que logran una remisión parcial de la proteinuria (UPE 24 horas <0.6 g/día)
    •Proporción de pacientes que logran una remisión total de la proteinuria (UPE 24 horas <0.3 g/día)
    •Proporción de pacientes que recibieron tratamiento de rescate para IgAN en cualquier momento durante el estudio.
    •Farmacocinética, farmacodinamia e inmunogenicidad del OMS721
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age 18 years or older at the onset of Screening
    •Biopsy confirmed diagnosis of IgAN within 10 years prior to Screening
    •Proteinuria of > 1 g in 24-hour urine collection at Screening and baseline
    •Estimated glomerular filtration rate of ≥ 30 and ≤ 90 mL/min/1.73 m2 at Screening and baseline
    •Currently on physician-directed, stable treatment with RAS blockade (ACEIs, ARBs, direct renin inhibitors) and have a systolic BP of < 150 mmHg and a diastolic BP of < 100 mmHg at rest
    •Tener 18 años o más al comienzo de la selección
    •Diagnóstico de IgAN confirmado por biopsia dentro de los 10 años anteriores a la selección
    •Proteinuria >1 g en una muestra de orina de 24 horas al momento de la selección y de la toma de valores basales
    •Tasa de filtración glomerular estimada ≥30 y ≤90 ml/min/1.73 m2 al momento de la selección y de la toma de valores basales
    •Estar recibiendo actualmente un tratamiento estable ordenado por un médico con un bloqueo del RAS (con ACEI, ARB, inhibidores directos de la renina) y tener una BP sistólica <150 mm Hg y una BP diastólica <100 mm Hg en reposo
    E.4Principal exclusion criteria
    •Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), cytotoxic drugs, or eculizumab within 24 weeks prior to Screening
    •Unwilling or unable to discontinue systemic corticosteroids 12 weeks prior to Randomization
    •Female patients who are pregnant, breast feeding, or planning to become pregnant up through 12 weeks after the last dose of study drug, including possible retreatments
    •Clinical or biological evidence of diabetes mellitus, systemic lupus erythematosus, IgA vasculitis (Henoch Schonlein purpura), secondary IgAN, or other renal disease
    •Presence of significant morbidity or other major illness or disease that may confound the interpretation of the clinical trial results or may result in death within 2 years of Screening
    •History of renal transplantation
    •Have a known hypersensitivity to any constituent of the investigational product
    •Rapidly progressive glomerulonephritis, defined as a fall in eGFR of > 30 mL/min/1.73 m2 within 24 weeks or > 15 mL/min/1.73 m2 within 3 months prior to Screening
    •Significant abnormalities in clinical laboratory values
    •Body mass index ≥ 35 kg/m²
    •History of human immunodeficiency virus (HIV), hepatitis B infection (including the presence of isolated anti-hepatitis B core), hepatitis C infection without prior curative treatment and sustained virologic cure, or evidence of immune suppression
    •Diagnosis of a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the patient has been disease free for ≥ 5 years
    •Have received any other investigational drug or device or experimental procedures within 30 days of the Screening Visit (SV)
    •Previously received OMS721
    •Tratamiento con inmunosupresores (p. ej., azatioprina o ciclofosfamida), medicamentos citotóxicos o eculizumab dentro de las 24 semanas anteriores a la selección
    •No estar dispuesto a interrumpir la administración de corticoesteroides sistémicos 12 semanas antes de la aleatorización, o no poder hacerlo
    •Ser una paciente de sexo femenino que esté embarazada, amamantando o que planifique quedar embarazada hasta las 12 semanas después de la última dosis del fármaco del estudio, incluido un posible nuevo tratamiento
    •Evidencia clínica o biológica de diabetes mellitus, lupus eritematoso sistémico, vasculitis por IgA (púrpura de Henoch Schonlein), IgAN secundaria u otra enfermedad renal
    •Presencia de morbilidad considerable u otra enfermedad importante que pueda confundir la interpretación de los resultados del ensayo clínico o que pueda causar la muerte en un plazo de 2 años luego de la selección
    •Antecedentes de trasplante de riñón
    •Hipersensibilidad conocida a cualquier compuesto del producto en fase de investigación
    •Glomerulonefritis de avance rápido, que se define como una disminución de la eGFR >30 ml/min/1.73 m2 en un plazo de 24 semanas o >15 ml/min/1.73 m2 en un plazo de 3 meses antes de la selección
    •Anomalías considerables en los valores de laboratorio clínico
    •Índice de masa corporal ≥35 kg/m²
    •Antecedentes de infección por el virus de la inmunodeficiencia humana (VIH), infección por el virus de la hepatitis B (incluida la presencia del anticuerpo del núcleo aislado de la hepatitis B), infección por el virus de la hepatitis C, sin un tratamiento previo que haya brindado una cura y la haya mantenido, o evidencia de inmunosupresión
    •Diagnóstico de una neoplasia maligna, con la excepción de cáncer de piel de células basales o escamosas adecuadamente tratado, enfermedad localizada que se haya curado con tratamiento u otro tipo de cáncer, si el paciente ha estado sin la enfermedad durante ≥5 años
    •Haber recibido cualquier otro fármaco o dispositivo en fase de investigación, o procedimiento experimental en un plazo de 30 días antes de la visita de selección (SV)
    •Haber recibido OMS721 previamente.
    E.5 End points
    E.5.1Primary end point(s)
    •The primary endpoint of this study is the change from baseline in 24-hour UPE at 24 weeks from BOT.
    •El criterio principal de valoración de este estudio es el cambio con respecto a los valores basales de UPE de 24 horas a las 24 semanas después del BOT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    E.5.2Secondary end point(s)
    •Safety and tolerability of OMS721 for the treatment of IgAN as assessed by AEs, vital signs, clinical laboratory tests, and ECGs
    •The rate of change in eGFR up to 144 weeks from BOT
    •Change from baseline in 24-hour UPE at 24 weeks from BOT in patients with baseline 24 hour UPE ≥ 2 g
    •Achievement of a treatment response defined as ≥ 30% reduction from baseline in 24 hour UPE at 24 weeks
    •Achievement of a partial response defined as a reduction between ≥ 15% and < 30% from baseline in 24-hour UPE at 24 weeks
    •Time averaged change from baseline in uPCR through 24 weeks. This will be measured as the time adjusted area-under-the-curve
    •Achievement of partial proteinuria remission defined as 24-hour UPE < 0.6 g/day at any time during study
    •Achievement of complete proteinuria remission defined as 24-hour UPE < 0.3 g/day at any time during study
    •Use of rescue therapy for IgAN at any time during the study
    •Change from baseline in eGFR at 24 weeks from BOT
    •Pharmacokinetics and pharmacodynamics of OMS721
    •Occurrence of ADA and, if present, NAb
    •La seguridad y tolerabilidad del OMS721 para el tratamiento de la IgAN, según la evaluación de EA, signos vitales, análisis de laboratorio clínico y ECG.
    •Tasa de cambio de la eGFR hasta las 144 semanas después del BOT.
    •Cambio con respecto a los valores basales de UPE de 24 horas a las 24 semanas desde el BOT en los pacientes con un valor inicial basal de UPE de 24 horas ≥2 g.
    •El logro de una respuesta al tratamiento, que se define como una reducción ≥30% en los valores basales de UPE de 24 horas a las 24 semanas.
    •El logro de una respuesta parcial al tratamiento, que se define como una reducción de entre ≥15% y <30% en los valores basales de UPE de 24 horas a las 24 semanas.
    •Cambio ponderado en el tiempo con respecto a los valores basales en el uPCR hasta las 24 semanas. Esto se medirá como el área bajo la curva ajustada con el tiempo.
    •El logro de una remisión parcial de la proteinuria, que se define como un valor de UPE de 24 horas <0.6 g/día en cualquier momento durante el estudio.
    •El logro de una remisión total de la proteinuria, que se define como un valor de UPE de 24 horas <0.3 g/día en cualquier momento durante el estudio
    •El uso de tratamiento de rescate para la IgAN en cualquier momento durante el estudio.
    •El cambio con respecto a los valores basales en la eGFR a las 24 semanas del BOT.
    •La farmacocinética y la farmacodinamia del OMS721.
    •La presencia de ADA y, en caso de estar presentes, NAb.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Italy
    Lithuania
    Poland
    Slovakia
    Spain
    Sweden
    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
    LVLS (última visita del ultimo paciente)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 434
    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)
    Applicable local standard of care
    Atención médica estándar local que aplique
    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 Decision2018-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-19
    P. End of Trial
    P.End of Trial StatusOngoing
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