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    Summary
    EudraCT Number:2021-000472-11
    Sponsor's Protocol Code Number:P20-08/BP1.4979
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-16
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-000472-11
    A.3Full title of the trial
    A double-blind, placebo-controlled pilot trial of BP1.4979 for the treatment of binge eating disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, placebo-controlled pilot trial of BP1.4979 for the treatment of binge eating disorder
    A.4.1Sponsor's protocol code numberP20-08/BP1.4979
    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 SponsorBIOPROJET PHARMA
    B.1.3.4CountryFrance
    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 supportBIOPROJET PHARMA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBIOPROJET PHARMA
    B.5.2Functional name of contact pointClinical Development Department
    B.5.3 Address:
    B.5.3.1Street Address9 rue Rameau
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75002
    B.5.3.4CountryFrance
    B.5.4Telephone number0033147036633
    B.5.5Fax number0033147036630
    B.5.6E-mailcontact@bioprojet.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.3.2Product code BP1.4979
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Binge eating disorder (BED)
    E.1.1.1Medical condition in easily understood language
    Binge eating disorder (BED)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level PT
    E.1.2Classification code 10004716
    E.1.2Term Binge eating
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    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 and safety of BP1.4979 15 mg BID in patients with moderate to severe binge eating disorder (BED).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient must voluntarily express a willingness to participate in this study, sign and date an informed consent prior to beginning any protocol required procedures.
    2.Female aged between 18 and 65 years, inclusive.
    3.Diagnosis of BED according to DSM-5 criteria. These criteria are:
    a.Recurrent episodes of binge eating. Both of the following characterize a binge-eating episode: 1. Eating, in a discrete period of time (e.g., within any 2-hour period), an amount of food that is definitely larger than what most people would eat in a similar period of time under similar conditions; and 2. A sense of lack of control over the eating during the episode (e.g., a feeling that one cannot stop eating or control what or how much one is eating).
    b.The binge-eating episodes are associated with at least three of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.
    c.Marked distress regarding binge eating.
    d.The binge eating occurs, on average, at least once a week for 3 months.
    e.The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
    4.At least two binge-eating days per week with at least 4 episodes during the 2 weeks prior to initiation of study medication, prospectively documented in take-home binge diaries.
    5.BMI < 50 kg/m2.
    6.In the opinion of the investigator, the patient has adequate support to comply with the entire study requirements as described in the protocol (e.g., transportation to and from trial site, ability to understand and fill in the self-rating scales, drug compliance, availability to attend to the scheduled visits, full understanding of the protocol etc..).
    The following inclusion criterion is to be checked at randomization:
    -Number of binge-eating days and number of episodes during the last 2 weeks.
    E.4Principal exclusion criteria
    1.Patient with a current diagnosis of bulimia nervosa or anorexia nervosa.
    2.History of bariatric surgery.
    3.Clinically unstable and concomitant medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease.
    4.Severe hepatic impairment or liver function tests (AST, ALT) > 3 ULN, renal impairment, or abnormal clinical laboratory results (in most cases > 3 ULN) specifically including hypokalemia.
    5.Suicidal ideation as evidenced by positive answer to questions 4 or 5 in the Columbia-Suicide-Severity Rating Scale (C-SSRS) at screening.
    6.Psychological (e.g., supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers) intervention for BED that was begun within the 3 months before study entry. Patients on such treatment for more than 3 months prior to screening may be enrolled if they agree not to make any changes to the frequency or nature of their treatment during the course of the study.
    7.History of suspected substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to screening or positive drug test at screening.
    8.Regular cannabis consumption.
    9.Use of psychostimulants to facilitate fasting or dieting as a part of the eating disorder within the past 6 months, misuse of psychostimulants within the past 6 months, or positive drug screen for psychostimulants at the screening visit.
    10.History (within the past year) of psychosis, severe mania or hypomania, or dementia or any other active clinically significant illness or any psychiatric disorder that might interfere with a diagnostic assessment, treatment, or study compliance.
    11.Ongoing alcohol or tobacco addiction treatment (except Nicotine Replacement Therapy [NRT] with at least one-month stable dose prior to screening visit).
    12.Patient who is pregnant, lactating, or of childbearing potential who is not using adequate contraceptive measures. The following are considered adequate methods of birth control: 1. intrauterine device (IUD); 2. barrier protection; 3. contraceptive implantation system; 4. oral contraceptive pills; 5. surgically sterile patient; and 6. abstinence. All participants should have a negative pregnancy test prior to randomization.
    13.Uncontrolled hypertension (>160/100 mmHg).
    14.Known history of long QTc syndrome or presenting on ECG:
    -a QTcF interval strictly higher than 450 ms (electrocardiogram Fridericia’s corrected QT interval = QT / 3 [60/HR]),
    -or any significant abnormality (e.g., within the last 3 months prior to screening: myocardial infarction, significant arrhythmias or conduction abnormalities) which in the opinion of the physician investigator precludes study participation.
    15.Prior (within the past 30 days prior to screening visit) or current therapy with any psychotropic medications including antidepressants (i.e., SSRIs, SNRIs, NRIs, monoamine oxidase inhibitors, either tricyclic or tetracyclic antidepressants), antipsychotics, antiepileptics, mood stabilizers, or psychostimulants, GLP-1 receptor agonists and therapy with herbal preparations and over-the-counter medications, except treatments for insomnia (e.g., hypnotics and sedative benzodiazepines).
    16.Known hypersensitivity to the tested treatment including active substance and excipients.
    17.Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator.
    18.No health insurance.
    The following exclusion criteria are to be checked at randomization:
    -Safety laboratory tests results not within the acceptable range.
    -Intake of any forbidden treatments, or changes that are not allowed by the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the change in the total number of binge-eating (BE) episodes per week based on the self-reported BE diaries, from the 2-week baseline (Day-14 to Day 0) compared to the last 2 weeks at the end of treatment period (Day 43 to Day 56).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation performed at V2, V3 and V5
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints will include:
    -Continuous Glucose Monitoring System (CGMS): to assess the number of dietary intakes (glycemic excursions) between meals identified as BE episodes by the Investigator.
    -Change of the Yale Food Addiction Scale (YFAS) from baseline to Week 8.
    -Change of the Clinical Global Impression (CGI) scale: CGI-Severity (CGI-S) and CGI-Improvement (CGI-I) from baseline to Week 8.
    -Change in the number of BE days per week from baseline to Week 7 and Week 8.
    E.5.2.1Timepoint(s) of evaluation of this end point
    V0, V1, V2, V3, V5
    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 concerned4
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 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 state66
    F.4.2 For a multinational trial
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-03
    P. End of Trial
    P.End of Trial StatusOngoing
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