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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2019-002281-12
    Sponsor's Protocol Code Number:SJX-653-006
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-09-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-002281-12
    A.3Full title of the trial
    A phase 2, prospective, randomized, double-blind, placebo-controlled clinical study to assess the efficacy, safety, tolerability, and pharmacokinetics of SJX-653 in postmenopausal women with moderate to severe vasomotor symptoms
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of SJX-653 on Menopausal Hot Flushes
    A.3.2Name or abbreviated title of the trial where available
    Effect of SJX-653 on Moderate to Severe Hot Flushes due to Menopause
    A.4.1Sponsor's protocol code numberSJX-653-006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04278872
    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 SponsorSojournix, 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 supportSojournix, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSojournix, Inc.
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street Address400 Totten Pond Road, Suite 110
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@sojournixpharma.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSJX-653
    D.3.2Product code SJX-653
    D.3.4Pharmaceutical form 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 INNNot assigned
    D.3.9.1CAS number Not assigned
    D.3.9.2Current sponsor codeSJX-653
    D.3.9.3Other descriptive nameSJX-653
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboTablet
    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
    Treatment of moderate to severe vasomotor symptoms (VMS) associated
    with menopause.
    E.1.1.1Medical condition in easily understood language
    Hot flushes associated with menopause.
    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 10027311
    E.1.2Term Menopause flushing
    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 evaluate the effect of oral SJX-653 on moderate to severe VMS symptom frequency after 4 weeks of treatment.
    E.2.2Secondary objectives of the trial
    Secondary:
    • Efficacy of oral SJX-653 on measures of VMS severity and frequency.
    • Safety and tolerability of SJX-653.
    • PK of SJX-653.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet the following criteria for inclusion:
    1. Signed a consent form before Screening procedures begin.
    2. Be a postmenopausal female, 40 to 65 years of age (inclusive) at the Screening Visit, defined as:
    a.Spontaneous amenorrhea for at least 12 months, OR
    b.6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL, OR
    c.6 weeks past a postsurgical bilateral oophorectomy with or without hysterectomy,
    All PMW must have a serum FSH >40 mIU/mL at Screening.
    3. Have an average of at least 7 moderate to severe VMS per day at Baseline
    The following definitions for severity are used:
    a.Mild: Sensation of heat without sweating/ damping; if at night, do not wake up but later notice damp sheets or clothing.
    b.Moderate: Sensation of heat with sweating/dampness, but able to continue activity; if at night, wake up because hot and/or sweating, but no action is necessary other than rearranging the bed sheets.
    c.Severe: Sensation of heat with sweating causing disruption of current activity; if at night, wake up hot and sweating and need to take action (eg, removing layer of clothes, open the window, or get out of bed).
    4. Have a body mass index between 18 and 35 kg/m2, inclusive.
    5. Have a clinical breast exam without clinically significant finding at Screening.
    6. For Subjects 50-65 years old, have documentation (written or electronic report) of a satisfactory mammogram result at Screening within applicable intervals stated in local breast cancer screening guidelines. Subjects 40-49 years old require a mammogram within the same intervals.
    7. Have documentation (written or electronic report) of a normal Pap smear (or equivalent cervical cytology) in combination with Human
    Papilloma virus (HPV) testing, or a Pap smear of no clinical significance in the opinion of the Investigator, at Screening within applicable
    intervals stated in local cervical cancer prevention guidelines.
    8. Be willing to undergo a transvaginal ultrasound to assess endometrial thickness at Screening and at Week 4 (EOT). This is not required for subjects who have had a partial (supracervical) or full hysterectomy.
    9. Have an endometrial thickness ≤4 mm by transvaginal ultrasound at Screening.
    10. Subjects must be willing to undergo an endometrial biopsy if they have unexplained bleeding during the study or an endometrial thickness >4 mm at the EOT Visit. An endometrial biopsy is not required for
    subjects who have had a partial (supracervical) or full hysterectomy.
    E.4Principal exclusion criteria
    1. Have clinically significant history or evidence of poorly controlled
    cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), or have any other medical condition that, in the Investigator's opinion, would make subjects unsuitable for participation in the study.
    2. Have manifest or suspected active COVID-19 infection:
    - Have tested +ve for SARS-CoV-2 based on a RT-PCR or other validated test, or
    - Have clinical symptoms suggestive of COVID-19 infection, or
    - Have to comply with quarantine requirements per local Public Health directive
    3. A history of diagnosis of major depressive disorder in the 3 years prior to Screening, or are on antidepressant, anxiolytic or antipsychotic treatment with the following exception:
    - SSRIs and SNRIs treatment for mild depression and/or mild anxiety are allowed provided medication is stable and well-tolerated in the 3 months prior to the Screening Visit and does not change during study participation.
    - SSRIs and SNRIs for treatment of VMS are prohibited.
    4. Have a history of suicide ideation or attempt in the past 3 years.
    5. Have a sleep disorder other than insomnia due to VMS.
    6. Have clinical or biochemical evidence of active hepatitis or other significant hepatic or biliary disease.
    7. Have abnormal liver function test laboratory values at Screening or
    Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (CKDEPI 2009 calculation; Levey 2009).
    8. Have tested positive for HIV antigen or antibodies, hepatitis B,C or E.
    9. Have any gastrointestinal, liver, kidney or other disorder that would significantly interfere with the absorption, distribution, metabolism, or excretion (ADME) of drugs in the opinion of the Investigator, including
    surgery (eg, short bowel syndrome, gastric or intestinal bypass surgery).
    10. Have a history of alcohol abuse or a history of substance abuse.
    11. Smoking >10 cigarettes per day.
    12. Regularly working night shifts.
    13. Have a history of hypersensitivity to more than two chemical classes of drugs, or known hypersensitivity to SJX-653 or any of its excipients.
    14. Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure as ≥90 mmHg, based on the median of a total of 4 to 6 readings, from 2 to 3 readings taken on 2 different occasions.
    15. Have poorly controlled Type II diabetes mellitus as defined by a glycosylated hemoglobin (HbA1c) >8.0% despite standard care.
    Subjects with Type I diabetes and subjects on insulin treatment are excluded.
    16. Have a history of or are on treatment for hyperthyroidism or hypothyroidism, or have abnormal thyroid tests at Screening. Subjects
    with subclinical hypothyroidism, and subjects on stable treatment for hypothyroidism for a least 3 months prior to Screening with normal
    thyroid function test results at Screening are allowed.
    17. Have clinically significant abnormal ECG or QT interval prolongation at Screening.
    18. Have a history of endometrial hyperplasia or uterine/endometrial cancer.
    19. Have current unexplained uterine bleeding.
    20. Have a history of cancer prior to Screening (other than local, treated basal cell or squamous cell carcinoma).
    21. Have any significant illness requiring hospitalization or emergency
    treatment within 4 weeks prior to the Screening Visit or during the Screening Period, as determined by the Investigator.
    22. Are pregnant or lactating.
    23. Are taking any drugs considered moderate or strong inducers and/or inhibitors of cytochrome P450 3A4 (CYP3A4).
    24. Started statin therapy less than 3 months prior to Screening, or are not on a stable and well tolerated dose in the 3 months prior to
    Screening.
    25. Have used any of the hormonal treatments listed in the protocol during the timeframes listed prior to the start of the Run-in Period:
    26. Are taking any nonhormonal medication for treatment of VMS in the 8-week period prior to the start of the Run-in Period.
    27. Have used herbal supplements or over-the-counter (OTC) medications for treatment of VMS 8 weeks prior to the start of the Runin
    Period. Any other herbal supplements or OTC supplements that could interfere with the study objectives require a 28-day wash-out period prior to the start of the Run-in Period.
    28. Are taking any antiestrogens, selective estrogen receptor modulators, or aromatase inhibitors.
    29. Are taking any antigonadotropin medication.
    30. Are legally or mentally incapacitated.
    31. Are not a suitable clinical study candidate per Investigator assessment
    32. Are currently participating in another drug or device clinical study or have received the last dose/device intervention in such a study within 90 days or 5 half-lives (whichever is longer) prior to the Screening Visit.
    33. Have previously received SJX-653 in another clinical study.
    34. Are directly involved in the conduct of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in average daily frequency of moderate to severe VMS from Baseline to Week 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 4.
    E.5.2Secondary end point(s)
    Efficacy
    • Mean change and percent change of parameters of VMS frequency and severity
    Safety
    • Change in clinical laboratory, vital signs, and ECGs
    Pharmacokinetic
    • Estimation of SJX-653 PK profile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to Week 4
    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) 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    LPLV (Last Patient Last 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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 No
    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 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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 66
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-03
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    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-Sun May 05 21:50:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA