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    Summary
    EudraCT Number:2018-002910-11
    Sponsor's Protocol Code Number:18-OBE001-010
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-30
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-002910-11
    A.3Full title of the trial
    A phase 3, double-blind, randomized, placebo-controlled study to assess the safety and efficacy of a single oral administration of nolasiban to increase ongoing pregnancy rate following fresh single blastocyst transfer resulting from IVF
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Placebo-controlled study to assess nolasiban to increase pregnancy rates in women undergoing IVF
    A.3.2Name or abbreviated title of the trial where available
    IMPLANT 4
    A.4.1Sponsor's protocol code number18-OBE001-010
    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 SponsorObsEva SA
    B.1.3.4CountrySwitzerland
    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 supportObsEva SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationObsEva SA
    B.5.2Functional name of contact pointClinical Trial Director
    B.5.3 Address:
    B.5.3.1Street Address12 Chemin des Aulx
    B.5.3.2Town/ cityPlan-Les-Ouates
    B.5.3.3Post code1228
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number410225523847
    B.5.5Fax number410227432921
    B.5.6E-mailclinicaltrials@obseva.ch
    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 namenolasiban
    D.3.2Product code OBE001 50mg
    D.3.4Pharmaceutical form Dispersible tablet
    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 INNNolasiban
    D.3.9.1CAS number 1477482-19-1
    D.3.9.2Current sponsor codeOBE001
    D.3.9.3Other descriptive nameNOLASIBAN (OBE001)
    D.3.9.4EV Substance CodeSUB130545
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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 namenolasiban
    D.3.2Product code OBE001 200mg
    D.3.4Pharmaceutical form Dispersible tablet
    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 INNNolasiban
    D.3.9.1CAS number 1477482-19-1
    D.3.9.2Current sponsor codeOBE001
    D.3.9.3Other descriptive nameNOLASIBAN (OBE001)
    D.3.9.4EV Substance CodeSUB130545
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboDispersible tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboDispersible tablet
    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
    Embryo implantation in women undergoing IVF with Day 5 fresh embryo transfer cycles
    E.1.1.1Medical condition in easily understood language
    Embryo implantation in women undergoing IVF with Day 5 fresh embryo transfer cycles
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10073184
    E.1.2Term Embryo transfer
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the live birth rate.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject must provide written informed consent prior to initiation of any study-related procedures, as shown by a signature on the Informed Consent Form.
    2. The subject must be aged 18 years to 37 years inclusive at screening.
    3. The subject must be indicated for IVF/ICSI in the context of assisted reproductive technology (ART).
    4. The subject must have undergone not more than one unsuccesful (no good quality embryos produced or negative βhCG test) controlled ovarian hyperstimulation (COH) for IVF or ICSI
    (whether fresh and/or several frozen ET resulted from that COH). Any attempts before a prior clinical pregnancy (observed embryo with heart beat) do not count.
    5. If the subject had one unsuccessful COH cycle, as described in inclusion criteria 4 above, they must have obtained at least one good quality embryo for transfer.
    6. The subject must in the current COH cycle for IVF/ICSI follow a GnRH antagonist protocol with or without pre-treatment with an oral contraceptive pill or estradiol.
    7. The subject must in the current COH cycle for IVF/ICSI receive a single injection of hCG for triggering final follicular maturation.
    8. The subject must in the current COH cycle for IVF/ICSI receive a luteal phase support with vaginal micronized progesterone at 600 mg per day beginning the morning after OPU.
    9. The subject must undergo oocyte retrieval for IVF/ICSI and subsequent fresh transfer on day 5 post-OPU day.
    10. The subject must have at least one good quality embryo in the current COH cycle.
    11. The subject is scheduled for a single fresh embryo transfer in the current COH cycle.
    12. The subject must have at least 1 functional ovary.
    13. The subject must have a BMI ≥ 18 kg/m2 and ≤ 38 kg/m2.
    14. The subject must be able to communicate well with the investigator and research staff and to comply with the requirements of the study protocol.
    15. The subject must agree to participate in the infant follow-up if she becomes pregnant.
    E.4Principal exclusion criteria
    1. The subject undergoes a frozen-thawed embryo transfer in the current transfer.
    2. The subject undergoes ET of an embryo from a donor egg in the current transfer.
    3. The subject’s partner required surgical testicular sperm extraction in that cycle.
    4. Use of assisted hatching and/or use of adherence compounds (e.g. EmbryoGlue®) for the embryo
    to be transferred in the study.
    5. The subject or partner has a known abnormal karyotype or the subject has known acquired or congenital thrombophilia disease.
    6. Any preimplantation genetic testing of the transferred embryo.
    7. The subject has any condition, including findings in the medical history or in the pre-trial assessments, which in the opinion of the investigator constitutes a risk or a contraindication for the participation of the subject in the trial or that could interfere with the trial objectives, conduct or evaluation.
    8. The subject has any clinically significant abnormality in the results of the screening safety laboratory tests, including AST, ALT, GGT, alkaline phosphatase or total bilirubin above twice upper limit of normal. In case of isolated GGT increase, a single re-test is allowed.
    9. The subject has a serum P4 level greater than 1.54 ng/mL prior to hCG administration.
    10. The subject had more than 20 oocytes retrieved in the current Controlled Ovarian Hyperstimulation (COH) cycle.
    11. Subject is known to have i) impaired ovarian reserve or ii) biomarker predictor of poor response e.g. FSH, AMH, AFC.
    12. The subject has any significant abnormality relevant to the ART procedure and outcome, in the
    results of a gynecological examination within 6 months of screening, which in the opinion of the investigator could interfere with the trial objectives, conduct or evaluation (e.g. significant
    uterine anomaly, communicating hydrosalpinx or fibroid(s) documented during ultrasound).
    13. The subject has diagnosed severe endometriosis (stage III or IV) and/or adenomyosis.
    14. The subject is at significant risk of severe ovarian hyper stimulation syndrome (OHSS).
    15. The subject has any history of uncontrolled hypertension and/or heart disease.
    16. The subject has known positive results from virology tests for hepatitis B surface antigen (HBsAg) (not due to vaccination), hepatitis C virus (HCV) or human immunodeficiency virus
    (HIV) 1 or 2. However, subjects who have resolved hepatitis B infection may be enrolled in the study.
    17. The subject is prone to frequent, severe hypersensitivity to drugs.
    18. The subject has been administered any experimental drug in the 12 weeks before dosing.
    19. The subject is likely to require treatment with drugs that are not permitted during the study from day 4 after OPU up to the Week 2 visit (OPU day + 14 days) such as:
    Drugs with utero-relaxant properties: calcium channel blockers, beta-sympathomimetic agents,
    nitroglycerine, parenteral magnesium sulfate (MgSO4), potassium channel openers, NSAIDs.
    20. The subject has autoimmune disease (e.g. lupus, rheumatoid arthritis) that is being medically treated.
    21. The subject has a history of, or known current (within twelve months) problems with alcohol or drug abuse.
    22. The subject has a history of recurrent pregnancy loss defined as 3 or more consecutive pregnancy losses including biochemical pregnancies. Miscarriage prior to a subsequent live birth does not count.
    23. The subject has a history of difficult transfers (e.g. tenaculum use or blood stained catheter).
    E.5 End points
    E.5.1Primary end point(s)
    Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post-ET day.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As soon as the last subject has completed week 10 and all data have been locked, the treatment groups will be unblinded, and the results up to the Week 10 visit will be analysed and described in a Clinical
    Study Report.
    E.5.2Secondary end point(s)
    Live birth after 24 weeks of gestation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after the data from the pregnancy outcome, newborn, and neonatal health at 28 days are available and the information from the ASQ-3 questionnaires (at 6 and 12 months after birth corrected for gestational age at birth.) has been collected
    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 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Belgium
    Canada
    Czech Republic
    Denmark
    Estonia
    Finland
    Germany
    Hungary
    Poland
    Russian Federation
    Spain
    E.8.7Trial has a data monitoring committee No
    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 date of the final clinical database lock (including the pregnancy, neonatal and infant 6 and 12-month follow-up).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 820
    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 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 729
    F.4.2.2In the whole clinical trial 820
    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)
    None
    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 Decision2018-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-19
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