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    Summary
    EudraCT Number:2021-003667-10
    Sponsor's Protocol Code Number:M21-500
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-05-09
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2021-003667-10
    A.3Full title of the trial
    A Phase 3, Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 multi-center research study to evaluate the safety and how well the study drug, AGN-151586, works for the treatment of glabellar lines (frown lines between the eyebrows)
    A.4.1Sponsor's protocol code numberM21-500
    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 SponsorAbbVie
    B.1.3.4CountryGermany
    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 supportAbbVie Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointGlobal Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628 561090
    B.5.5Fax number+441628461153
    B.5.6E-mailglobal-clinical-trials@abbvie.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 nameBotulinum Neurotoxin Serotype E (BoNT/E)
    D.3.2Product code AGN-151586
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBotulinum Neurotoxin Serotype E (BoNT/E)
    D.3.9.1CAS number 1350492-91-9
    D.3.9.2Current sponsor codeAGN-151586
    D.3.9.3Other descriptive nameClostridium botulinum, serotype E, neurotoxin (150 kDa)
    D.3.9.4EV Substance CodeSUB223978
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Glabellar Lines (GL)
    E.1.1.1Medical condition in easily understood language
    Frown line wrinkles between the eyebrows and result from the repeated muscle movements that are associated with common facial expressions.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this pivotal study is to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in subjects with moderate to severe GL
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult male or female, at least 18 years old
    - Subjects must be able to accurately assess their facial lines without the use of eyeglasses (contact lens use is acceptable)
    - Subjects must be in good health as per investigator's judgment based on medical history, physical examination, neurological assessment, clinical laboratory evaluations, ECG results, and vital sign measurements.
    - Subjects must have moderate or severe GL at maximum frown as assessed by both the investigator and subject using the FWS at Screening and Baseline Day 1 Visit. The investigator and subject ratings must match within a visit but do not have to match between Screening and Baseline Day 1.
    E.4Principal exclusion criteria
    - Subjects who have an uncontrolled systemic disease
    - Subjects who have previously received treatment with any botulinum neurotoxin of any serotype for aesthetic treatment within the last 6 months prior to Baseline Day 1 and for therapeutic treatment within the last 12 months prior to Baseline Day 1
    - Subjects who presents with or have a history of any medical condition that may place the subject at increased risk following exposure to AGN-151586 or interfere with the study evaluation, including:
     Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
     History of facial nerve palsy
     Infection or dermatological condition at the treatment injection sites
     Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart
     Any eyebrow or eyelid ptosis at Screening or Baseline Day 1 Visits as determined by the investigator
    - Subjects who have a history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
    - Subjects who have a history of an allergic reaction or significant sensitivity to constituents of the study drug (or its excipients).
    - Subjects who have tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed.
    - Subjects who have a known immunization to any botulinum neurotoxin serotype.
    - Subjects who have an anticipated need for surgery or overnight hospitalization during the study.
    - Subjects who have a history of surgical procedures on forehead and/or periorbital areas or affecting these areas including any lifting procedure (e.g., rhinoplasty, facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
    - Subjects who have a history of periorbital, mid-facial, or upper-facial treatment with semi-permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide,
    polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
    - Female subjects who are pregnant or breastfeeding, or are considering becoming pregnant or donating eggs during the study or within approximately 30 days after the last dose of study drug or before the end of study, whichever is longer.
    - Subjects who have been treated with any investigational drug within 30 days prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
    - Subjects who have an anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).
    - Subjects who have a clinically relevant or significant ECG abnormalities, including ECG with QT interval corrected for heart rate using Fridericia's formula > 450 msec (males) or > 470 msec (females).
    - Subjects with known active COVID infection or subjects with a positive polymerase chain reaction (PCR) test in the past 14 days prior to Baseline Day 1
    - Female subjects of child-bearing potential who have a positive serum pregnancy test at screening and a positive urine pregnancy test at the Baseline Day 1 Visit (prior to the dose of study drug).
    - Female subjects who are pregnant or breastfeeding, and are considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer.
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary endpoints are:
    - ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale (FWS) according to subject assessment of GL severity at maximum frown at Day 7
    - ≥ 2-grade improvement from baseline on the FWS according to investigator assessment of GL severity at maximum frown at Day 7
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7 (6 days after the baseline Day 1 visit)
    E.5.2Secondary end point(s)
    a. Key secondary endpoint: ≥ 20-point improvement from baseline in FLO-11 total scores for GL at Day 7
    b. ≥ 2-grade improvement from baseline on the FWS according to subject assessment of GL severity at maximum frown at Hour 24
    c. ≥ 2-grade improvement from baseline on the FWS according to investigator assessment of GL severity at maximum frown at Hour 24
    d. ≥ 1-grade improvement from baseline on FWS according to subject assessment of GL severity at maximum frown at Hour 24
    e. ≥ 1-grade improvement from baseline on FWS according to investigator assessment of GL severity at maximum frown at Hour 24
    f. Mostly satisfied or Very satisfied on the FLSQ follow-up version Item 5 (overall satisfaction) for GL at Hour 24
    g. Mostly satisfied or Very satisfied on the FLSQ follow-up version Item 4 (natural look) for GL at Day 7
    h. Time to the first ≥ 1-grade improvement from baseline on the FWS according to subject assessment of GL severity at maximum frown (double-blind period)
    i. Time to the first ≥ 1-grade improvement from baseline on the FWS according to investigator assessment of GL severity at maximum frown (double-blind period)
    j. ≥ 2-grade improvement from baseline on the FWS according to subject assessment of GL severity at maximum frown over time (double-blind period)
    k. ≥ 2-grade improvement from baseline on the FWS according to investigator assessment of GL severity at maximum frown over time (double-blind period)
    l. Time to return to baseline FWS according to subject assessment of FWS at maximum frown (double-blind period)
    m. Time to return to baseline FWS according to investigator assessment of FWS at maximum frown (double-blind period)
    n. Mostly satisfied or Very satisfied on the FLSQ follow-up version Item 5 (overall satisfaction) for GL over time
    o. ≥ 4-point improvement from baseline in FLO-11 Item 10 (look angry) for GL at Day 7
    p. ≥ 4-point improvement from baseline in FLO-11 Item 5 (look less attractive) for GL at Day 7
    q. Subject-reported global assessment of change in GL based on the Global Assessment of Change in Glabellar Lines (GAC-GL) over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Endpoints: a, g, o & p - Day 7
    - Endpoints: b, c, d, e & f - 24 Hour
    - Endpoints: h, i, j, k, l & m - Day 1 to Day 43
    - Endpoints: n & q - Duration of study
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Second treatment period is Open
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 States
    Poland
    Germany
    Hungary
    Russian Federation
    United Kingdom
    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
    The end of study is defined as the date of end of study participation by the last subject in the study.
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 600
    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 Decision2022-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-17
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