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    Summary
    EudraCT Number:2018-002763-26
    Sponsor's Protocol Code Number:814-PM-02
    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:2018-10-11
    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 number2018-002763-26
    A.3Full title of the trial
    A DOUBLE-BLIND, RANDOMISED, PLACEBO CONTROLLED, ADAPTIVE DESIGN STUDY OF THE EFFICACY, SAFETY AND PHARMACOKINETICS OF NT-814 IN FEMALE SUBJECTS WITH MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH THE MENOPAUSE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NT-814 in menopausal females with vasomotor symptoms (SWITCH-1 study)
    A.3.2Name or abbreviated title of the trial where available
    The “SWITCH-1” Study
    A.4.1Sponsor's protocol code number814-PM-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03596762
    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 SponsorNeRRe Therapeutics Ltd,
    B.1.3.4CountryUnited Kingdom
    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 supportKaNDy Therapeutics Ltd,
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeRRe Therapeutics Ltd,
    B.5.2Functional name of contact pointSusan Seymore
    B.5.3 Address:
    B.5.3.1Street AddressStevenage Bioscience Catalyst, Incubator Building, Gunnels Wood Rd.,
    B.5.3.2Town/ cityStevenage,
    B.5.3.3Post codeSG1 2FX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441438 906960
    B.5.6E-mailsusan.seymore@nerretherapeutics.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 nameNT-814
    D.3.4Pharmaceutical form Capsule, soft
    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 INNNT-814
    D.3.9.1CAS number 929046-33-3
    D.3.9.2Current sponsor codeNT-814
    D.3.9.3Other descriptive nameGSK1144814A
    D.3.9.4EV Substance CodeSUB31853
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboCapsule, soft
    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
    Hot flushes (vasomotor symptoms) in menopausal women
    E.1.1.1Medical condition in easily understood language
    Hot flushes
    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 20.0
    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 efficacy of once daily doses of 40 mg, 80 mg, 120 mg and 160 mg NT-814, compared with placebo, in reducing the frequency and severity of hot flushes.
    To assess the safety and tolerability of once daily doses of 40 mg, 80 mg, 120 mg and 160 mg NT-814, compared with placebo, in subjects with post-menopausal symptoms.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of once daily doses of 40 mg, 80 mg, 120 mg and 160 mg NT-814, compared with placebo, on mental well-being, quality of life and measures of sleep in subjects with post-menopausal symptoms.
    To evaluate the dose-response relationship of 40 mg, 80 mg, 120 mg and 160 mg NT-814 in reducing hot flush frequency and severity.

    Pharmacokinetics Objective:
    To evaluate the exposure-response relationship of NT-814 using population pharmacokinetics (PK) with sparse sampling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Females aged 40 to 65 years, inclusive, at Screening Visit 1
    2.Able to understand and comply with the requirements of the study and give informed consent
    3.Postmenopausal, defined as: (i) at least 12 months of spontaneous amenorrhea, or (ii) at least 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml and a serum oestradiol concentration of < 30 pg/mL, or (iii) at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
    4.Body mass index between 18 and 38 kg/m2, inclusive, at Screening Visit 2
    5.Negative urinary pregnancy test at Screening Visit 2
    6.In good general health, in the opinion of the investigator, based on the medical history, physical examination, 12-lead ECG, vital signs and clinical laboratory tests assessed at Screening Visit 2
    7.Subject has completed the paper diary for at least 6 days between Screening Visits 1 and 2 and has recorded an average of at least 8 moderate or severe hot flushes per day (including night-time) over the last 5 days that the paper diary was completed (assessed at Screening Visit 2)
    8.Subject has completed the eDiary for at least 9 days between Screening Visit 2 and Day 1 and has recorded an average of at least 7 moderate or severe hot flushes per day (including night-time) over the last 7 days that the eDiary was completed (assessed at the Baseline Visit)
    E.4Principal exclusion criteria
    1.Have used or unwilling to wash-out use of any of the following hormonal therapies for the periods stated prior to Screening Visit 2:
    ->1 week for vaginal hormonal products (rings, creams, gels and including DHEA or analogues thereof)
    ->4 weeks for transdermal oestrogen alone or oestrogen/progestin products
    ->8 weeks for oral oestrogen (including selective oestrogen receptor modulators) and/or progestin therapy
    ->8 weeks for intrauterine progestin therapy
    ->3 months for progestin implants and oestrogen alone injectable drug therapy
    ->6 months for oestrogen pellet therapy or progestin injectable drug therapy
    2.The use of non-hormonal prescription (eg paroxetine, other anti-depressants, alpha agonists [eg clonidine], methyldopa, gabapentin, pregabalin, medicinal cannabis) or over the counter/herbal treatments for treatment of menopausal symptoms is not allowed throughout the study. Subjects must have discontinued these drugs at least 28 days prior to Screening Visit 2. Subjects may, however, be permitted to continue to use these drugs if the dose has been stable for at least 4 weeks and they have been prescribed solely for the management of another disorder (e.g. neuropathic pain, depression).
    3.Inability to comply with the use of prohibited medications as described below:
    i.Use of digoxin is not allowed from Screening Visit 2 until 1 week after the last dose of IMP
    ii.Use of known CYP3A4 substrates with a narrow therapeutic range is not allowed from Screening Visit 2 until 1 week after the last dose of IMP
    iii.Use of strong or moderate inhibitors of CYP3A4 is not allowed from Screening Visit 2 until 1 week after the last dose of IMP
    iv.Use of moderate or strong inducers of CYP3A4 is not allowed from Screening Visit 2 until Week 12
    v.Use of known P-glycoprotein inhibitors is not allowed from Screening Visit 2 until 1 week after the last dose of IMP
    4.Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of Screening Visit 1
    5.Any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ECG evaluation.
    6.Any clinically significant abnormal laboratory test result(s), measured at Screening Visit 2.
    7.Any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms such as: infection that could have caused pyrexia, pheochromocytoma, hyperthyroidism, carcinoid syndrome, alcohol abuse.
    8.Current history or previous (within the past 5 years) history of any malignancy (except basal and squamous cell skin tumours).
    9.Uncontrolled hypertension
    10.A history of hyperthyroidism or hypothyroidism. Treated hypothyroidism with normal thyroid function test results at Screening Visit 2 and a stable (for >3 months before Screening Visit 2) dose of replacement therapy is acceptable.
    11.Known hypersensitivity to NT-814 or any of the excipients in the formulation.
    12.Concurrent (or within the 2 months prior to Screening Visit 1) participation in a clinical study with an investigational medicinal product.
    13.Concurrent (or within the 1 month prior to Screening Visit 1) participation in an interventional clinical study.
    14.Previous participation in a clinical study with NT-814.
    15.Dependent on the investigator, the contract research organisation(s) or Sponsor for education or employment.
    16.Any unexplained post-menopausal bleeding.
    17.Abnormal findings on mammogram or subject has not undergone a mammogram within the guidelines recommended by applicable national authorities (eg United Kingdom National Health Service, United States Preventative Services Taskforce, Canadian Task Force on Preventative Healthcare)

    E.5 End points
    E.5.1Primary end point(s)
    There are four co-primary efficacy endpoints:
    •Mean change from baseline in frequency of moderate and severe hot flushes from baseline to Week 4
    •Mean change from baseline in frequency of moderate and severe hot flushes from baseline to Week 12
    •Mean change from baseline in severity of moderate and severe hot flushes from baseline to Week 4
    •Mean change from baseline in severity of moderate and severe hot flushes from baseline to Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4 and 12
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints include:
    •Mean change from baseline in frequency of moderate and severe hot flushes from baseline to Weeks 1, 2, 8 and 16
    •Mean change from baseline in severity of moderate and severe hot flushes from baseline to Weeks 1, 2, 8 and 16
    •Mean change from baseline in frequency of all hot flushes from baseline to Weeks 1, 2, 4, 8, 12 and 16
    •Mean change from baseline in severity of all hot flushes from baseline to Weeks 1, 2, 4, 8, 12 and 16
    •Mean change from baseline in the Hot Flush Score (frequency x severity) at Weeks 1, 2, 4, 8, 12 and 16
    •Responder analyses: proportion of subjects with >50% and >80% reduction from baseline in hot flush frequency at Week 12
    •Mean change from baseline in number of night time awakenings secondary to hot flush at Weeks 1, 2, 4, 8, 12 and 16
    •Mean change from baseline in number of all night time awakenings at Weeks 1, 2, 4, 8, 12 and 16
    •Change from baseline in the Global and individual domain scores of the Pittsburgh Sleep Quality Index at Weeks 4, 8, 12 and 16
    •Change from baseline in the Insomnia Severity Index score at Weeks 4, 8, 12 and 16
    •Change from baseline in the HFRDIS scores at Weeks 2, 4, 8, 12 and 16
    •Change from baseline in the MenQoL-I scores at Weeks 4, 8, 12 and 16
    •Change from baseline in the Beck Depression Inventory II scores at Weeks 2, 4, 8, 12 and 16

    Pharmacokinetic endpoints:
    •Exposure-response modelling will be undertaken on a number of efficacy and safety endpoints on an exploratory basis.

    Safety endpoints:
    •Change from baseline in clinical laboratory assessments (haematology, clinical chemistry, urinalysis) at Weeks 2, 4, 12 and 16
    •Change from baseline in vital signs (blood pressure, pulse rate, temperature) at Weeks 2, 4, 8, 12 and 16
    •Change from baseline in weight, waist circumference and body mass index at Weeks 2, 4, 8, 12 and 16
    •Proportion of subjects with clinically significant abnormal ECG findings at each visit
    •Proportion of subjects with non-significant abnormal ECG findings at each visit
    •Change from baseline at Weeks 2, 4, 8, 12 and 16 in ECG intervals (RR, PR, QT, QTc and QTcF)
    •Proportion of subjects with maximum absolute QTcF values by category at each visit
    -<450, >450 to <480, >480 to <500, >500 msec
    •Proportion of subjects with maximum change from baseline in ECG QTcF values by category at Weeks 2, 4, 8, 12 and 16
    -<0, >0 to <30, >30 to <60, >60 msec
    •Change from baseline in the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16
    •Change from baseline to Weeks 12 and 16 in:
    -Serum concentration of bone-specific alkaline phosphatase (BALP)
    -Serum concentration of procollagen type 1 N-terminal propeptide (P1NP)
    •Nature and severity of AEs
    •Withdrawals due to an AE
    •Use of concomitant medications

    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 1,2, 4, 8, 12, 16
    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 Yes
    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 trial5
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    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
    LVLS
    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 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: 164
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 165
    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 Decision2018-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-21
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