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    EudraCT Number:2017-004958-42
    Sponsor's Protocol Code Number:MOM-M281-003
    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:2019-03-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-004958-42
    A.3Full title of the trial
    A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
    Un estudio multicéntrico, abierto para evaluar la seguridad, la farmacocinética y la farmacodinámica del M281 administrado a mujeres embarazadas con alto riesgo de aparición temprana de enfermedad hemolítica grave del feto y recién nacido (EHRN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open Label Study to Evaluate the Safety and Efficacy of M281 Given to Pregnant Women at High Risk for Early Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
    Un estudio abierto para evaluar la seguridad y eficacia del M281 administrado a mujeres embarazadas con alto riesgo de aparición temprana de enfermedad hemolítica grave del feto y recién nacido (EHRN)
    A.4.1Sponsor's protocol code numberMOM-M281-003
    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 SponsorMomenta Pharmaceuticals, 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 supportMomenta Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMomenta Pharmaceuticals Inc.
    B.5.2Functional name of contact pointChelsea Toner
    B.5.3 Address:
    B.5.3.1Street Address301 Binney Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    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 nameM281
    D.3.4Pharmaceutical form Concentrate for 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 INNM281
    D.3.9.1CAS number 2211985-36-1
    D.3.9.2Current sponsor codeM281
    D.3.9.4EV Substance CodeSUB182674
    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 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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
    Early onset Severe Hemolytic Disease of the fetus and newborn (HDFN)
    enfermedad hemolítica grave de aparición temprana del feto y recién nacido (EHRN)
    E.1.1.1Medical condition in easily understood language
    Pregnant women that are at risk of developing early onset of severe hemolytic disease that affects the fetus and neonate
    Mujeres embarazadas que están en riesgo de desarrollar una enfermedad hemolítica severa que afecta al feto y al neonato
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019512
    E.1.2Term Hemolytic disease due to Rh isoimmunization of fetus or newborn
    E.1.2System Organ Class 100000004850
    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 safety in mother and neonate/infant of M281 administered to pregnant women at high risk for early onset severe HDFN (EOS-HDFN).
    • To evaluate the efficacy of M281 as measured by proportion of patients with live birth at or after gestational age (GA) 32 weeks without intrauterine transfusion (IUT).
    •Evaluar la seguridad del M281 en la madre y el neonato/lactante cuando se administra a mujeres embarazadas con alto riesgo de aparición temprana de EHRN grave (AT-EHRN).
    •Evaluar la eficacia del M281 determinada mediante la proporción de pacientes con un nacimiento vivo en o después de la edad gestacional (EG) de 32 semanas sin transfusión intrauterina (TIU).
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of M281 on antenatal management and outcome as measured by GA at first fetal IUT and frequency of fetal IUT.
    •To evaluate the efficacy of M281 on postnatal management and outcome as measured by severity of hyperbilirubinemia, phototherapy, exchange transfusions, and transfusions in the first 3 months of life.
    •To evaluate the PD activity of M281 as measured by effects on maternal FcRn occupancy, and maternal and neonatal/infant levels of total IgG and alloantibodies.
    •To evaluate the PK of M281.
    • Evaluar la eficacia del M281 para el tratamiento prenatal y desenlace determinada mediante la EG en el momento de la primera TIU fetal y la frecuencia de TIU fetales.
    • Evaluar la eficacia del M281 para el tratamiento posnatal y desenlace determinada mediante la gravedad de la hiperbilirrubinemia, la fototerapia, las transfusiones de intercambio y las transfusiones en los 3 primeros meses de vida.
    • Evaluar la actividad FD del M281 determinada mediante los efectos sobre la ocupación del RFcn materna y los niveles de IgG total y aloanticuerpos maternos y del neonato/lactante.
    • Evaluar la FC del M281.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Able to understand and voluntarily provide written informed consent to participate in the study.
    2.Female and ≥18 years of age.
    3.Pregnant with an estimated GA of 8 to 13 weeks.
    4.A previous pregnancy with a gestation that included at least one of the following at ≤24 weeks gestation:
    a.Severe fetal anemia, defined as hemoglobin ≤0.55 multiples of the median (MoM) for GA **refer to table on page 12 of the protocol.
    b.Fetal hydrops (ascites) with an MCA-PSV MoM ≥1.5
    c.Stillbirth with fetal or placental pathology indicative of HDFN
    5.Maternal alloantibody titers for anti-D of ≥32, or anti-Kell titers ≥8.
    6.Free fetal deoxyribonucleic acid (DNA) consistent with an antigen positive fetus (blood sample taken from mother).
    7.Maternal evidence for immunity to measles mumps, rubella, and varicella, as documented by laboratory reports obtained from medical history or serologies performed during Screening.
    8.Screening IgG and albumin levels within the laboratory normal range for gestational age of pregnancy.
    9.Willing to receive standard of care with IUT if clinically indicated.
    10.Agree to recommended vaccinations per local standard of care for both mother and child throughout the course of the study.
    11.Willing to forego participation in another clinical trial of an investigational therapy for the duration of their participation in the current study.
    12.Willing to consent to a 6 month safety follow-up period for the patient and a 24 month safety follow-up period for the neonate/infant.
    1.Ser capaz de entender y otorgar voluntariamente un consentimiento informado por escrito para participar en el estudio.
    2.Mujer ≥18 años de edad.
    3.Mujer embarazada con una EG estimada de 8 a 13 semanas.
    4.Existencia de un embarazo previo que incluyó al menos uno de los siguientes a las ≤24 semanas de gestación:
    a.Anemia fetal grave, que se define como hemoglobina ≤0,55 múltiples de la mediana (MdM) para la EG (ver table pág 12 del Protocolo)
    b.Edema fetal (ascitis) con una MdM de la VSM-ACM ≥1,5.
    c.Mortinato con una patología fetal o placentaria indicativa de EHRN.
    5.Valores de aloanticuerpos maternos anti-D ≥32 o valores de anti-Kell ≥8.
    6.Ácido desoxirribonucleico (ADN) libre fetal indicativo de un feto con resultado positivo para el antígeno (muestra de sangre extraída de la madre).
    7.Indicios de inmunidad materna al sarampión, parotiditis, rubéola y varicela, documentada mediante informes de análisis clínicos obtenidos del historial médico o mediante análisis de serología realizado durante la selección.
    8.Niveles de IgG y albúmina dentro del intervalo analítico normal para la edad gestacional del embarazo en la selección.
    9.Estar dispuesta a recibir tratamiento estándar con TIU si está clínicamente indicado.
    10.Acceder a recibir las vacunas recomendadas conforme a la práctica clínica habitual local, tanto para la madre como para el hijo, durante el transcurso del estudio.
    11.Estar dispuesta a renunciar a la participación en otro ensayo clínico con un tratamiento en investigación mientras participe en el estudio actual.
    12.Estar dispuesta a otorgar el consentimiento para someterse a un periodo de seguimiento de la seguridad de 6 meses para la paciente y un periodo de seguimiento de la seguridad de 24 meses para el neonato/lactante.
    E.4Principal exclusion criteria
    1.Currently pregnant with multiples (twins or more).
    2.Pre-eclampsia in current pregnancy or history of pre-eclampsia in a previous pregnancy.
    3.History of severe or recurrent pyelonephritis, 4 or more lower urinary tract infections in the past year or in a previous pregnancy, or genital herpes.
    4.Positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C during Screening.
    5.Active infection at Screening or Baseline with Coxsackie, syphilis, cytomegalovirus, toxoplasmosis or herpes simplex 1 or 2, as evidenced by clinical signs and symptoms (evidence for prior infection or exposure, but without clinical signs and symptoms of active infection is acceptable).
    6.Active infection with tuberculosis as evidenced by positive QuantiFERON-TB testing.
    7.Requires treatment with corticosteroids or immunosuppression for disorders unrelated to the pregnancy (use of low-potency topical corticosteroids or intra-articular corticosteroids is permitted).
    8.History of drug allergy, hypersensitivity, or intolerance to any drug product that, in the opinion of the Investigator, would compromise the safety of the patient.
    9.In the Investigator’s opinion, shows evidence of ongoing alcohol/substance abuse/dependence.
    10.Smoking during pregnancy.
    11.Received plasmapheresis and/or IVIG during the current pregnancy for treatment of HDFN.
    12.Received an investigational drug and/or device within 30 days or 5 half-lives prior to receiving the first IV infusion of M281.
    13.A history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine/metabolic, immunologic, severe or recurrent infections (eg, frequent hospitalized pneumonia), dermatologic, neurologic, oncologic, or psychiatric disease, or any other condition or issue that, in the opinion of the Investigator, would jeopardize the safety of the patient or fetus/neonate/infant or the validity of the study results.
    1.Embarazo múltiple actual (gemelos o más).
    2.Preeclampsia en el embarazo actual o antecedentes de preeclampsia en un embarazo anterior.
    3.Antecedentes de pielonefritis grave o recurrente, de 4 o más infecciones de las vías urinarias bajas en el año previo o en un embarazo anterior o de herpes genital.
    4.Resultado positivo en la prueba de detección del virus de la inmunodeficiencia humana (VIH), hepatitis B o hepatitis C durante la selección.
    5.Infección activa en la selección o al inicio por virus Coxsackie, sífilis, citomegalovirus, toxoplasmosis o herpes simple 1 o 2, que se demuestra por signos y síntomas clínicos (se aceptan aquellos casos en los que existan indicios de infección previa o de exposición, pero sin signos y síntomas clínicos de infección activa).
    6.Infección activa de tuberculosis que se demuestra por un resultado positivo en la prueba QuantiFERON-TB.
    7.Necesidad de tratamiento con corticoesteroides o inmunodepresión para trastornos no relacionados con el embarazo (se permite el uso de corticoesteroides tópicos de poca potencia o corticoesteroides intraarticulares).
    8.Antecedentes de alergia farmacológica, hipersensibilidad o intolerancia a cualquier fármaco que, en opinión del investigador, pondría en riesgo la seguridad de la paciente.
    9.Pacientes que, en opinión del investigador, muestren indicios de abuso o dependencia de alcohol o de sustancias en curso.
    10.Tabaquismo durante el embarazo.
    11.Pacientes que han recibido plasmaféresis o IgIV durante el embarazo actual para el tratamiento de EHRN.
    12.Pacientes que han recibido un fármaco o dispositivo en investigación en los 30 días o 5 semividas anteriores a recibir la primera infusión i.v. del M281.
    13.Antecedentes o presencia de infección cardiovascular, pulmonar, hepática, renal, hematológica, gastrointestinal, endocrina/metabólica o inmunológica, grave o recurrente, clínicamente significativa (p. ej., neumonía que requiere la hospitalización frecuente), de enfermedad dermatológica, neurológica, oncológica o psiquiátrica,o cualquier otra afección o problema que, en opinión del investigador, pueda poner en peligro la seguridad de la paciente, del feto/neonato/lactante o la validez de los resultados del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1) Incidence and severity of AEs, SAEs, and AESIs (i.e., infections requiring use of oral or intravenous anti-infectives in the patient; hypoalbuminemia ≥ Grade 3)

    2)Proportion of patients with live birth at or after GA Week 32 without IUT
    1. Incidencia y gravedad de los EA, los EASs y los EASIs (es decir, infecciones que requieren el uso de antiinfecciosos orales o intravenosos en el paciente; hipòalbuminemia>_ Grado 3)
    2. Proporción de pacientes con nacidos vivos en o despue´s de GA semana 32 sin IUT
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) continuous throughout the whole trial

    2)week 32
    1. continuo durante todo el ensayo
    2. semana 32
    E.5.2Secondary end point(s)
    1) Desirability of Overall Clinical Outcome, as defined by ranking of the pregnancy outcome (live birth or fetal loss), neonate transfusion for anemia/hyperbilirubinemia, intervention for fetal anemia (timing and frequency of IUT).
    2) Percentage of patients with live birth
    3) Percentage of patients at GA Week 24 without an IUT
    4) GA at first IUT
    5) Number of IUTs required
    6) GA at delivery
    7) Percentage of patients with fetal hydrops
    8) Percentage of neonates requiring phototherapy
    9) Percentage of neonates requiring exchange transfusions
    10) Number of days of phototherapy required by neonate
    11) Percentage of neonates requiring simple transfusions in the first 3 months of life
    12) Number of simple transfusions required by neonate in the first 3 months of life
    1)Conveniencia del resultado clínico general, definida por la valoración del desenlace del embarazo (nacimiento vivo o pérdida del feto), transfusión del neonato debido a anemia/hiperbilirrubinemia, intervención debido a anemia fetal (puntos temporales y frecuencia de la TIU).
    2)Porcentaje de pacientes con un nacimiento vivo.
    3)Porcentaje de pacientes sin una TIU en la EG de 24 semanas.
    4)Edad gestacional en el momento de la primera TIU.
    5)Número de TIU necesarias.
    6)Edad gestacional al parto
    7)Porcentaje de pacientes con edema fetal.
    8)Porcentaje de neonatos que requieren fototerapia.
    9)Porcentaje de neonatos que requieren transfusiones de intercambio.
    10)Número de días de fototerapia requeridos por el neonato.
    11)Porcentaje de neonatos que requieren transfusiones simples en los 3 primeros meses de vida.
    12)Número de transfusiones simples requeridas por el neonato en los 3 primeros meses de vida
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) at birth
    2) at birth
    3) at Week GA 24
    4) at first IUT
    5) at birth
    6) after birth
    7) within first 3 months of birth
    8) within first 3 months of birth
    9) within first 3 months of birth
    10) within first 3 months of birth
    11) within first 3 months of birth
    1) al nacer
    2) al nacer
    3) en la EG semana 24
    4) a la primera TIU
    5) al nacer
    6) despues de nacer
    7) dentro de los primeros 3 mesees de nacimiento
    8) dentro de los primeros 3 mesees de nacimiento
    9) dentro de los primeros 3 mesees de nacimiento
    10) dentro de los primeros 3 mesees de nacimiento
    11) dentro de los primeros 3 mesees de nacimiento
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Will assess immunogenicity of M281
    Evaluará la inmunogenicidad de M281
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    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
    End of trial is LVLS
    El fin de Ensayo es la última visita del ultimo paciente
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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: 15
    F.1.1.1In Utero Yes
    F. of subjects for this age range: 15
    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: 15
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 No
    F.3.3.3Pregnant women Yes
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 15
    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)
    Standard of Care
    Cuidado estandar
    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 Decision2019-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-18
    P. End of Trial
    P.End of Trial StatusOngoing
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