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    Summary
    EudraCT Number:2017-003932-35
    Sponsor's Protocol Code Number:BIO101-CL03
    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:2017-10-02
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-003932-35
    A.3Full title of the trial
    Safety and Efficacy of BIO-101 175 mg b.i.d. and 350 mg b.i.d. 26-week oral administration to patients suffering from age-related SARcopenia, including sarcopenic obesity, Aged ≥65 years and at risk of mobility disability. A double-blind, placebo controlled, randomized INTerventional Clinical Trial (SARA-INT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    na
    A.4.1Sponsor's protocol code numberBIO101-CL03
    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 SponsorBiophytis S.A.
    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 supportBiophytis
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiophytis
    B.5.2Functional name of contact pointWaly Dioh
    B.5.3 Address:
    B.5.3.1Street Address14 Avenue de l’Opéra
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75001
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 (0)1 44 27 23 00
    B.5.6E-mailwaly.dioh@biophytis.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 BIO-101
    D.3.4Pharmaceutical form Capsule
    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 INNBIO101
    D.3.9.1CAS number 5289-74-7
    D.3.9.2Current sponsor codeBIO101
    D.3.9.3Other descriptive name20-hydroxyecdysone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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
    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
    Sarcopenia including sarcopenic obesity
    E.1.1.1Medical condition in easily understood language
    Sarcopenia including sarcopenic obesity
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10063024
    E.1.2Term Sarcopenia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the safety and efficacy of two doses of BIO101 (175
    mg b.i.d. and 350 mg b.i.d.) orally administered for 26 weeks
    versus placebo in a population of community dwelling older men
    and women (aged ≥ 65 years) living at home and at risk of
    mobility disability.
    2. To estimate treatment effect on improvement of physical
    function after a six-month treatment versus placebo in the target
    population.
    3. To estimate treatment effect on reduced risk of mobility
    disability after a six-month treatment versus placebo in the
    target population.
    E.2.2Secondary objectives of the trial
    a. To compare the change from baseline of a standardized patient
    reported outcome (PRO): the PF-10 sub-score of the SF-36. A
    minimum clinically significant benefit is set at 2-point difference
    of the change at M6 from baseline versus placebo in the mean
    difference between groups.
    b. To compare the change from baseline to month 6 of the muscle
    strength using the handgrip strength test. A minimum clinically
    significant benefit is set at 2 kg difference of the change at M6
    from baseline versus placebo in the mean difference between
    groups
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A population PK sub-study (SARA-POP-PK), with the objective of assessing pharmacokinetic values after 1 month, 3 months or 6 months in a subset of participants in the European centers.
    E.3Principal inclusion criteria
    1. Provision of signed and dated informed consent form (ICF)
    2. Stated willingness to comply with all study procedures and
    availability for the duration of the study
    3. Male or female aged ≥ 65 years, living in the community
    (living at home, able to walk outside from time to time. Homes
    can include any living community that may or may not offer
    optional services for the convenience of the residents. Older
    adults living in nursing homes or in medicalized residences
    where caretaker services are mandatory are not eligible) and
    reporting a loss of physical function over the last 6-12
    months
    4. SPPB score ≤ 8
    5. ALM/BMI < 0.789 in men and <0.512 in women, or ALM <
    19.75kg in men and < 15.02kg in women, as measured by
    DEXA scan
    6. Ability to take oral medication and be willing to adhere to the
    study intervention regimen (see section 6)
    7. Agreement to adhere to the outlined Lifestyle Considerations
    (see section 5.4) throughout the study duration
    8. In the US, women and members of minority groups should not
    be excluded, in accordance with the NIH Policy on Inclusion of
    Women and Minorities as Participants In Research Involving
    Human Subjects.
    E.4Principal exclusion criteria
    1. Current use of anabolic drugs (e.g. testosterone); current use
    of Erythropoietin; current use of corticosteroid agents (except ocal administration route, like eye drops or dermatologic formulations)
    2. Non-menopaused women (however, ongoing hormonal
    replacement hormonal treatment is not an exclusion criterion)
    3. Known allergic reactions to sourcing components of the investigational drug (i.e. Cyanotis species; e.g. Cyanotis arachnoidea C.B. Clarke or Cyanotis vaga Lour. (Shultes)
    leaves and roots)
    4. Treatment with another investigational drug or other interventions within three months
    5. Unable to understand and perform the functional tests, as judged by the Investigator
    6. Inability to perform the 400MW test within 15 minutes
    7. Clinical conditions:
    a. Current diagnosis of major psychiatric disorders.
    b. Alcohol abuse or dependence
    c. Severe arthritis
    d. Cancer requiring active treatment (cancer previously
    treated with chemotherapy and/or radiotherapy and
    participants currently on remission is not an exclusion
    criterion)
    e. Lung disease requiring regular use of supplemental
    oxygen
    f. Inflammatory conditions requiring regular use of oral
    or parenteral corticosteroid agents
    g. Severe cardiovascular disease (including New York
    Heart Association [NYHA] class III or IV congestive
    heart failure, clinically significant valvular disease,
    history of cardiac arrest, presence of an implantable
    defibrillator, or uncontrolled angina)
    h. Parkinson’s disease or other progressive neurological
    disorder
    i. Renal disease requiring dialysis, or known renal
    insufficiency (moderate or severe reduction of
    eGFR≤30 ml/min/1.73 m2, based on Cockroft & Gault
    formula)
    j. Chest pain, severe shortness of breath, or occurrence
    of other safety concerns during the baseline
    functional tests such as the 400MW test
    k. History or active signs or symptoms of
    gallbladder/biliary disease (e.g. previous episodes of
    cholestasis/biliary tract obstruction, cholelithiasis,
    cholecystitis, etc.). Of note, history of
    cholecystectomy and no active biliary signs or
    symptoms, is not an exclusion criterion.
    8. Current physical/rehabilitation therapy (except for passive
    physical therapy. However, this should not be initiated the
    week before an evaluation visit and once started, it should be
    maintained over the study duration).
    E.5 End points
    E.5.1Primary end point(s)
    Gait speed measured during the 400MW test, the change from baseline to month 6 will be compared between groups of treatment (each dose versus placebo).
    E.5.1.1Timepoint(s) of evaluation of this end point
    during trial
    E.5.2Secondary end point(s)
    PF-10 subscore of the SF-36: the change from baseline to month 6 will be compared between groups of treatment (each dose versus placebo).
    Muscle strength as measured by the handgrip test: the change from
    baseline to month 6 will be compared between groups of treatment
    (each dose versus placebo)
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the trial
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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 trial3
    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 concerned3
    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 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
    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 years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 231
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 231
    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)
    see protocol
    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 Decision2017-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-20
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