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    Summary
    EudraCT Number:2014-000084-40
    Sponsor's Protocol Code Number:NT-05
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-31
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-000084-40
    A.3Full title of the trial
    A randomized, double blind, multi-center, placebo-controlled study to evaluate the efficacy, safety, and tolerability of NT100 in pregnant women with a history of unexplained recurrent pregnancy loss (RPL).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A placebo controlled study of efficacy and safety in pregnant women with a history of unexplained recurrent pregnancy loss.
    A.4.1Sponsor's protocol code numberNT-05
    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 SponsorNora Therapeutics, 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 supportNora Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGranzer Regulatory Consulting & Services
    B.5.2Functional name of contact pointNicola Richter
    B.5.3 Address:
    B.5.3.1Street AddressZielstattstr 44
    B.5.3.2Town/ cityMunich
    B.5.3.3Post codeD-81379
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989780 68 9822
    B.5.5Fax number+4989780 68 9815
    B.5.6E-mailrichter@granzer.biz
    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.3.2Product code NT100
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unexplained recurrent pregnancy loss. A distinct disorder from sporadic pregnancy loss and is characterized by the loss of multiple pregnancies
    E.1.1.1Medical condition in easily understood language
    Recurrent pregnancy loss or recurrent miscarriage
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10072314
    E.1.2Term Pregnancy loss
    E.1.2System Organ Class 100000004868
    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 subcutaneous NT100 (rhG-CSF) vs. placebo in pregnant women with a history of unexplained recurrent pregnancy loss
    • To evaluate the safety, tolerability, and immunogenicity of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pre-menopausal female 18-37 years of age at consent, trying to conceive
    2. Documented history of unexplained recurrent pregnancy loss, defined as:
    a. Spontaneous loss of three or more pregnancies prior to 20 completed weeks of gestation
    b. At least two of the losses must have involved intrauterine clinical pregnancies prior to
    20 completed weeks of gestation with normal or unknown fetal karyotype
    3. Spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site
    4. Body mass index (BMI) of 19-35 kg/m2 at consent
    E.4Principal exclusion criteria
    1. Greater than 5 weeks of gestation (i.e. greater than 3 weeks since the ovulation date) when presenting for randomization. Ovulation date is defined as the day after the ovulation test is first positive.
    2. Known karyotype abnormalities in either the participant or her current male partner
    3. Uncorrected clinically significant intrauterine abnormalities present at the time of consent (as assessed by ultrasound, hysterosonography, hysterosalpingography, or hysteroscopy within 3 years prior to consent)
    4. Abnormal vaginal bleeding of unknown cause
    5. Current diagnosis of infertility in either the participant or her current male partner
    6. Current or past diagnosis of the following:
    a. Systemic autoimmune disease (e.g. systemic lupus erythematosus, Hashimoto’s thyroiditis, Graves’ disease, rheumatoid arthritis)
    b. Antiphospholipid syndrome or disorder presence of lupus anticoagulant or anti-cardiolipin antibodies
    c. Protein C or S deficiency
    d. Other thrombophilia or evidence of thrombophilia (e.g. recurrent deep vein thrombosis, pulmonary embolism)
    e. Hyperprolactinemia
    f. High risk of cervical incompetence in the investigator’s opinion
    g. High-grade cervical dysplasia with conization/surgery
    7. Any uncontrolled clinically significant medical condition (e.g. asthma, type II diabetes, infection)
    8. The following laboratory abnormalities at initial consent and within 3 months prior to randomization
    a. Thrombocytopenia or thrombocytosis (platelet count < 75,000/µL or > 500,000/µL)
    b. Neutropenia or neutrophilia (absolute neutrophil count < 1500/µL or > 10,000/µL)
    c. Leukopenia or leukocytosis (white blood cell count < 3000/µL or > 15,000/µL)
    d. Creatinine, hepatic transaminases, lactate dehydrogenase (LDH), alkaline phosphatase, or uric acid ≥ 1.5x upper limit of normal (ULN)
    9. Use of lithium within 1 month prior to consent
    10. Known hypersensitivity to any rhG-CSF drug product, any of its components, or any E. coli-derived proteins
    11. History of any of the following conditions:
    a. Human immunodeficiency virus (HIV) infection
    b. Malignancy within the past 5 years other than treated basal cell carcinoma or squamous cell carcinoma of the skin
    c. Splenomegaly or splenic rupture
    d. Adult respiratory distress syndrome (ARDS), acute lung injury (ALI), or pulmonary edema
    e. Sickle cell anemia
    f. Acute myocardial infarction, stroke, or revascularization (coronary or cerebral)
    12. Previous rhG-CSF therapy for any indication
    13. In the investigator’s opinion, any contraindication to the use of an investigational drug
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the clinical pregnancy rate at Week 20 of gestation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    20 weeks
    E.5.2Secondary end point(s)
    1. Live birth
    2. Live birth beyond 34 weeks of gestation
    3. Clinical pregnancy at Week 6, 8 and 12 of gestation
    4. Spontaneous pregnancy loss under 24 weeks
    5. Stillbirth
    6. Neonatal birth weight
    7. Infants discharged alive from the hospital following delivery
    8. Maternal adverse events and serious adverse events during the treatment period and within 4 weeks of the last dose of study drug
    9. Changes in clinical laboratory parameters following study drug exposure
    10. Major congenital anomalies
    11. Diagnosis of pre-eclampsia, eclampsia, gestational hypertension, or placenta accreta
    12. Incidence of anti-drug antibody (ADA) formation
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Live birth
    2. Live birth beyond 34 weeks of gestation - >34 weeks
    3. clinical pregnancy rate at Week 6, 8 & 12 of gestation - 6, 8 & 12 weeks
    4. Spontaneous pregnancy loss - <24 weeks
    5. Stillbirth - >=24 weeks
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 clinical trial is defined as the last study visit for the last participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months21
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months21
    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: 150
    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 Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state150
    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)
    Participants will no longer receive study-related treatment or benefits after completion of the study. Participants will be able to continue standard of care treatment for themselves and their infants outside of the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Reproductive Health and Childbirth Network (REACH) Name of contact person
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-06
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