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    Summary
    EudraCT Number:2017-004958-42
    Sponsor's Protocol Code Number:MOM-M281-003
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-18
    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 ConcernedSweden - MPA
    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)
    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)
    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
    B.5.6E-mailclinicaltrialinfo@momentapharma.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/3/19/2209
    D.3 Description of the IMP
    D.3.1Product namenipocalimab
    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 INNnipocalimab
    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.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 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)
    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
    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 nipocalimab administered to pregnant women at high risk for early onset severe HDFN (EOS-HDFN).
    • To evaluate the efficacy of nipocalimab as measured by proportion of patients with live birth at or after gestational age (GA) 32 weeks and without an intrauterine transfusion (IUT) throughout their entire pregnancy.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of nipocalimab on antenatal management and outcome as measured by GA at first fetal IUT, frequency of fetal IUT, and frequency of live birth.
    • To evaluate the efficacy of nipocalimab on postnatal management and outcome as measured by severity of hyperbilirubinemia, phototherapy, exchange transfusions, and transfusions in the first 12 weeks of life.
    • To evaluate the PD activity of nipocalimab as measured by effects on maternal FcRn occupancy, and maternal and neonatal/infant levels of total IgG and alloantibodies.
    • To evaluate the PK of nipocalimab.
    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 to an estimated GA of 8 up to 14 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 ≥4.
    6. Free fetal deoxyribonucleic acid (DNA) consistent with an antigen positive fetus (blood sample drawn from the mother).
    7. Maternal evidence for immunity to measles mumps, rubella, and varicella, as documented by serologies performed during Screening. If initial serologies are borderline
    or negative, they may be repeated at a second lab. Alternatively, vaccination records can
    be used to support evidence of immunity.
    8. Screening IgG and albumin levels within the laboratory normal ranges.
    9. Willing to receive standard of care with IUT if clinically indicated.
    10. Agree to receive recommended vaccinations per local standard of care for both mother and child throughout the course of the study.
    11. Willing to forego collection of cord blood for stem cell storage or other non-study purposes.
    12.For mother and neonate, willing to forego participation in another clinical trial of an investigational therapy for the duration of their participation in the current study.
    13. Willing to consent to a 24-week safety follow-up period for the patient and a 96-week safety follow-up period for the neonate/infant.
    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. Gestational hypertension in the current pregnancy
    4. Current unstable hypertension
    5. History of severe or recurrent pyelonephritis; or 4 or more lower urinary tract infections in the past year or in a previous pregnancy
    6. History of genital herpes infection
    7. History of atypical mycobacterial disease or herpes zoster infection within the last 6 months.
    8. History of malignancy (except treated basal cell carcinoma of the skin) with or without systemic cancer chemotherapy.
    9. Positive for HIV, hepatitis B, or hepatitis C during Screening.
    10. Presence of any of the following during Screening: clinically significant abnormal hematologic laboratory values, creatinine >1.5 X upper limit normal (ULN), or clinically significant abnormal ECG reflective of heart disease.
    11. 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).
    12. Active infection with tuberculosis as evidenced by positive QuantiFERON-TB testing.
    13. Immunosuppression because of underlying medical condition, including:
    • History of hereditary or congenital immunodeficiencies, cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia
    • History of solid organ or bone marrow transplantation
    • Any prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease that may jeopardize the safety of the subject, require therapy that would interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results.

    14. Requires treatment with corticosteroids or immunosuppression for disorders unrelated to the pregnancy (use of low-potency topical corticosteroids or intra-articular corticosteroids is permitted).
    15. 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.
    16. In the Investigator’s opinion, shows evidence of ongoing alcohol/substance abuse/dependence.
    17. Smoking during pregnancy.
    18. Received plasmapheresis and/or IVIG during the current pregnancy for treatment of HDFN.
    19. Received live vaccine within 3 months prior to receiving the first IV infusion of nipocalimab
    20.Currently receiving an antibody-based drug or an Fc-fusion protein drug
    21. Received an investigational drug and/or device within 30 days or 5 half-lives prior to receiving the first IV infusion of nipocalimab.
    22.Received nipocalimab in a prior clinical trial
    23. A history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine/metabolic, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, or 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.
    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 and without an IUT throughout their entire pregnancy
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) continuous throughout the whole trial

    2)week 32 and at birth

    E.5.2Secondary end point(s)
    1) Global Clinical Outcome
    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) Gestational age 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 12 weeks of life
    12) Number of simple transfusions required by neonate in the first 12 weeks of life
    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 12 weeks of birth
    8) within first 12 weeks of birth
    9) within first 12 weeks of birth
    10) within first 12 weeks of birth
    11) within first 12 weeks of birth
    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
    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) 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 No
    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
    Australia
    Belgium
    Canada
    Germany
    Netherlands
    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
    End of trial is LVLS
    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 months4
    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.1.1.1.1Number 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.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
    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 Decision2019-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-08
    P. End of Trial
    P.End of Trial StatusOngoing
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