Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-004042-14
    Sponsor's Protocol Code Number:16-OBE2109-015
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-004042-14
    A.3Full title of the trial
    An exploratory single centre, open label, pilot study investigating the efficacy and safety of OBE2109 200 mg daily for 12 weeks followed by 100 mg daily for 12 weeks in uterine adenomyosis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot study to assess the efficacy and safety of OBE2109 in subjects with uterine adenomyosis.
    A.4.1Sponsor's protocol code number16-OBE2109-015
    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 Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressChemin des Aulx 12, Plan-Les-Ouates
    B.5.3.2Town/ cityGeneva
    B.5.3.3Post code1228
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41(0)225523840
    B.5.5Fax number+41(0)227432921
    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 nameOBE2109
    D.3.2Product code OBE2109
    D.3.4Pharmaceutical form Film-coated 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.3.9.2Current sponsor codeOBE2109
    D.3.9.3Other descriptive nameOBE2109
    D.3.9.4EV Substance CodeSUB182059
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Uterine adenomyosis
    E.1.1.1Medical condition in easily understood language
    Uterine adenomyosis
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10058953
    E.1.2Term Adenomyosis uteri
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of 200 mg OBE2109 daily for 12 weeks followed by 100 mg OBE2109 daily for 12 weeks on reduction of the volume of the uterus with adenomyosis.
    E.2.2Secondary objectives of the trial
    Efficacy objectives
    The efficacy of OBE2109 will be further assessed in:
    · Reducing pelvic pain in subjects with moderate to severe pain due to the adenomyosis condition
    · Reducing pain associated with sexual intercourse (dyspareunia)
    · Reducing pain associated with defecation (dyschezia)
    · Improving quality of life
    · The subject’s perception of change in her adenomyosis condition
    · Reducing incidence of uterine bleeding

    Safety objective
    To assess the overall safety of 24 weeks of daily administration of OBE2109 in subjects with uterine adenomyosis.
    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.
    2. The subject must be a pre-menopausal woman aged between 18 and 48 years inclusive at screening.
    3. The subject must have history of regular menstrual cycles every 21-35 days and without intermenstrual bleeding heavier than spotting or staining.
    4. The subject has Follicle-Stimulating Hormone (FSH) level ≤ 20 IU/L at screening.
    5. The subject has uterine adenomyosis confirmed on MRI with:
    · Junctional-Zone width on T2 weighted images ≥12mm, and
    · Moderate to severe pain according to the mB&B classification for two criteria out of deep
    dyspareunia, pelvic pain or dysmenorrhea, and
    · Presence of abnormal uterine bleeding.
    6. The subject has a Body Mass Index (BMI) ≥18 and ≤35 kg/m².
    7. If of childbearing potential, the subject agrees to use one of the following birth control methods during the entire length of the treatment period of the study:
    a. Sexual abstinence from heterosexual intercourse if routinely and consistently practised
    b. Partner with vasectomy performed at least 6 months prior to the screening visit and with confirmed azoospermia
    c. Double non-hormonal barrier contraception such as condom or diaphragm each combined with spermicide.
    8. If of non-childbearing potential, the subject must have had tubal ligation sterilisation at least 2 months before the screening visit.
    E.4Principal exclusion criteria
    1. The subject has an abnormal endometrial biopsy within 6 months prior to starting study treatment (atypical hyperplasia, endometritis, polyps or carcinoma).
    2. The subject underwent prior major uterine procedures like uterine artery embolization and
    myomectomy/endometrial ablation in the 6 months preceding the screening visit, or any other significant uterine abnormalities on MRI (of note: previous caesarean section, dilation and curettage, and diagnostic hysteroscopy are permitted).
    3. The subject has had uterine surgery for uterine adenomyosis, i.e. adenomyomectomy (hysteroscopic
    resection is acceptable).
    4. The subject has any uterine dimension >20 cm.
    5. The subject has had breast examination findings requiring intervention within the 6 months preceding the screening visit.
    6. The subject has or has had an active pelvic infection within 1 month preceding the screening visit.
    7. The subject is using an intrauterine device (IUD) or she has used an IUD within the 3 months preceding the screening visit.
    8. The subject is likely to require treatment during the study OR received treatment within a specified period prior to the screening visit with any of the medications listed below:
    • Gonadotropin releasing hormone (GnRH) antagonists 3 months
    • GnRH agonist injections/3-month depot injections 3 months/6 months
    • Oral contraceptives and other sex hormones 1 month
    • Depot contraceptives 6 months
    • Selective Progesterone Receptor Modulators (SPRMs)
    Selective Estrogen Receptor Modulators (SERMs) 3 months
    • Systemic glucocorticoid treatments for acute diseases (not depot) 1 month
    9. The subject is using or anticipates to use any of the following drugs: anticoagulants, aminocaproic acid, or any other medications that affect menstrual bleeding such as tranexamic acid.
    10. The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study.
    11. The subject has history of known failed treatment with GnRH agonists or GnRH antagonists.
    12. The subject has history of or current systemic glucocorticoid therapy for treatment of chronic diseases (e.g. Systemic Lupus Erythematosus (SLE), rheumatic arthritis).
    13. The subject has history of, or known osteoporosis or other metabolic bone disease.
    14. The subject has alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT) or total bilirubin ≥ 2 times the upper limit of normal.
    15. The subject has known positive HIV or viral hepatitis serology.
    16. The subject has any known condition, including findings in the medical history or in the screening
    assessments which, in the opinion of the investigator, constitutes a risk or a contraindication to the
    participation of the subject in the trial or that could interfere with the trial objectives, conduct or evaluation.
    17. The subject has history of (within twelve months prior to the screening visit), or known current problems with alcohol or drug abuse (including painkiller abuse).
    18. The subject has any condition rendering her unable to understand the nature, scope and possible
    consequences of the study, and/or evidence of an uncooperative attitude.
    19. The subject has been administered any experimental drug in the 12 weeks before start of study treatment.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to week 24 in volume of the uterus with adenomyosis measured by Magnetic Resonance Imaging (MRI).
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24
    E.5.2Secondary end point(s)
    Efficacy:
    1. Change from baseline to weeks 12 and 36 in volume of the uterus with adenomyosis measured by MRI
    2. Change from baseline to weeks 12, 24 and 36 in volume of the uterus with adenomyosis measured by transvaginal ultrasound (TVUS)
    3.Change from baseline to weeks 12, 24 and 36 in the largest thickness of the anterior and posterior part of the uterus myometrium (sagittal assessment)
    4. Change from baseline to weeks 12, 24 and 36 in the largest diameter of the junctional zone of the uterine adenomyosis measured by MRI
    5. Presence of blood spots on the MRI images
    6. Change from baseline to weeks 12, 24 and 36 in uterus volume assessed at vaginal examination
    7. Change from baseline to weeks 12, 24 and 36 in uterine tenderness assessed at vaginal examination
    8. Change from baseline to weeks 12, 24 and 36 in dysmenorrhea, pelvic pain and dyspareunia according to the modified Biberoglu & Behrman (mB&B) scale
    9. Change from baseline to weeks 4, 8, 12, 16, 20, 24 and 36 in global pelvic pain assessed over the preceding 4-week period using a Numerical Rating Scale (NRS) with a monthly recall
    10.Change from baseline to weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36 in the mean monthly dyspareunia score defined as the mean of available daily dyspareunia scores over the preceding 4-week period assessed on the Verbal Rating Scale (VRS) dyspareunia scale and on a NRS
    11. Change from baseline to weeks 4, 8, 12, 16, 20 and 24 in the mean monthly dyschezia score defined as the mean of weekly dyschezia scores over the preceding 4-week period using a NRS
    12. No uterine bleeding (or spotting only), during the 4-week period preceding weeks 4, 8, 12, 16, 20 and 24 using a simplified bleeding scale
    13. Time to amenorrhea
    14. Change from baseline to weeks 12, 24 and 36 in the Endometriosis Health Profile questionnaire (EHP-30)
    15. Patient Global Impression of Change (PGIC) score at weeks 12, 24 and 36

    Safety:
    1. Treatment Emergent Adverse Events (TEAEs)frequency and severity
    2. Changes from baseline to weeks 4, 8, 12, 16, 20 and 24 in clinical laboratory assessments (haematology, coagulation parameters, haemoglobin, biochemistry, estradiol and lipids)
    3. Any pathological changes from baseline in the endometrium as assessed by histology from endometrial biopsies performed at week 24 (and week 36 only if no endometrial biopsy was obtained at week 24 or diagnosis at week 24 was different from “benign endometrium”)
    4. Change from baseline in any other safety parameters including weight, vital signs, gynecological assessment, breast assessment and endometrial thickness
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy:
    1. week 12 and 36
    2. week 12, 24 and 36
    3. week 12, 24 and 36
    4. week 12, 24 and 36
    5. week 12, 24 and 36
    6. week 12, 24 and 36
    7. week 12, 24 and 36
    8. week 12, 24 and 36
    9. week 4, 8, 12, 16, 20, 24, 36
    10. week 4, 8, 12, 16, 20, 24, 28, 32, 36
    11. week 4, 8, 12, 16, 20, 24
    12. week 4, 8, 12, 16, 20, 24
    13. throughout the study
    14. week 12, 24, 36
    15. week 12, 24, 36

    Safety:
    1. throughout the study
    2. week 4, 8, 12, 16, 20, 24
    3. week 24, 36
    4. throughout the study
    9. week 4, 8, 12, 16, 20, 24, 36
    10. week 4, 8, 12, 16, 20, 24, 28, 32, 36
    11. week 4, 8, 12, 16, 20, 24
    12. week 4, 8, 12, 16, 20, 24,
    13. check time to amenorrhea
    14. week 12, 24, 36
    15. week 12, 24, 36
    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 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 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 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
    For administrative and safety reporting purposes the end of the study will be defined as the date of the final clinical database lock after the last subject has completed Week 36 visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned 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: 9
    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 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 state9
    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 Decision2018-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 15:02:52 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA