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    Summary
    EudraCT Number:2018-004384-31
    Sponsor's Protocol Code Number:MT10109L-001
    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:2019-06-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-004384-31
    A.3Full title of the trial
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MT10109L in the Treatment of Glabellar Lines
    A.3.2Name or abbreviated title of the trial where available
    MT10109L in the Treatment of Glabellar Lines
    A.4.1Sponsor's protocol code numberMT10109L-001
    A.5.4Other Identifiers
    Name:INDNumber:121473
    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 SponsorAllergan 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 supportAllergan Sales LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointCTRG
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow International, Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailML-CTRG@Allergan.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 namenivobotulinumtoxinA
    D.3.2Product code MT10109L
    D.3.4Pharmaceutical form 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 INNNA
    D.3.9.1CAS number 93384-43-1
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboSolution 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
    Glabellar Lines
    E.1.1.1Medical condition in easily understood language
    Treatment of Glabellar Lines (GL) - deep furrows or frown lines in the glabellar area of the face
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052609
    E.1.2Term Glabellar frown lines
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy between 24 U MT10109L and placebo for the treatment of GL in participants with moderate to severe GL
    E.2.2Secondary objectives of the trial
    • To compare the efficacy between MT10109L and placebo for the treatment of GL in participants with moderate to severe GL
    • To compare the safety between MT10109L and placebo for the treatment of GL in participants with moderate to severe GL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant must be ≥ 18 years of age and considered to be an adult in her/his local jurisdiction at the time of signing the informed consent.
    - Moderate to severe GL at maximum frown (as assessed by both the investigator and participant; investigator and participant ratings must be the same) using the FWS.
    - Participants must have sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their GL lines, in the opinion of the investigator.
    - Male and female
    - Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
    - Female participants of childbearing potential must have a negative urine pregnancy test before each study intervention. A female is considered NOT to be of childbearing potential if she is premenarchal, postmenopausal (at least 12 consecutive months without menstruation), or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral oophorectomy).
    - Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    - Written informed consent from the participant has been obtained prior to any study-related procedures.
    - Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable. (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]).
    - Ability to follow study instructions, including completing study assessment tools without any assistance or alteration to the assessment tools and likely to complete all required visits.
    E.4Principal exclusion criteria
    - Any condition which precludes a participant’s ability to comply with study requirements, including completion of the study visits or inability to read, understand, and/or self-assess GL severity using FWS.
    - Known immunization or hypersensitivity to any botulinum toxin serotype.
    - Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
    - Any history of significant cardiovascular disease, family history of long QT syndrome, or a clinically significant electrocardiogram (ECG) abnormality at the Screening Visit.
    - Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or the inability to substantially lessen facial lines even by physically spreading them apart, as determined by the investigator.
    - Any brow or eyelid ptosis, as determined by the investigator.
    - Infection or skin disorder at the injection sites.
    - History of facial nerve palsy.
    - Any uncontrolled systemic disease.
    - Recent history of alcohol or drug abuse based on the investigator’s judgment
    - Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention).
    - Anticipated need for surgery or overnight hospitalization during the study.
    - Prior exposure to botulinum toxin of any serotype for any reason
    - Any of the following procedures or treatments occurring in the specified period before enrollment (Day 1):
    - 3 months: any facial nonablative resurfacing laser, light or ultrasound treatment, microdermabrasion, or superficial peels
    - 6 months: any facial cosmetic procedure with medium depth or deep depth chemical peels (eg, trichloroacetic acid [TCA] and phenol); periorbital, mid-facial, or upper-facial skin resurfacing; or permanent make-up in the mid-facial (extending from inferior orbital margin to level of the nasal base) or upper facial areas
    - 12 months: any periorbital, mid-facial, or upper-facial treatment with nonpermanent soft tissue fillers
    - Participants on topical retinoid therapy and/or topical hormone cream applied to the face, who have not been on a consistent dose regimen for at least 6 months before enrollment and who are unable to maintain the same regimen for the study.
    - Participants on oral retinoid therapy within 1 year before study enrollment.
    - Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).
    - Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation.
    - Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
    - Females who are pregnant, nursing, or planning a pregnancy during the study.
    - Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol specified study visits.
    - Participants who, in the investigator’s opinion, are unable or unwilling to maintain their standardized skin care regimen throughout the study period.
    - The participant has a condition or is in a situation which, in the investigator’s opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of participants achieving a rating of none or mild on the FWS according to investigator and participant assessments of GL severity at maximum frown at Day 30 using the mITT population after a single IM injection of MT10109L or placebo in the GL
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 30
    E.5.2Secondary end point(s)
    • Secondary: The duration of GL treatment effect estimated as the median time to return to moderate or severe GL at maximum frown in participants who achieved a rating of none or mild GL severity at maximum frown at Day 30 according to investigator assessments using the FWS
    • Secondary: The proportion of participants reporting mostly satisfied/very satisfied on a 5-point scale of very dissatisfied to very satisfied at Day 60 on the FLSQ follow-up version Item 5 for GL
    • Secondary: The proportion of participants with ≥ 20-point improvement from baseline at Day 30 on the FLSQ Impact domain for GL
    • Secondary: The proportion of responders for investigator assessments of GL severity at rest using the FWS among participants who were rated at least mild at rest at baseline, where a responder is defined as achieving a ≥ 1-grade improvement from baseline at Day 30
    • Secondary: The proportion of responders for participant assessments of GL severity at rest using the FWS among participants who were rated at least mild at rest at baseline, where a responder is defined as achieving a ≥ 1-grade improvement from baseline at Day 30
    • Secondary: The proportion of participants with a ≥ 20-point improvement from baseline at Day 30 on the FLO-11© questionnaire total score for GL
    • Secondary: The proportion of participants with a > 4-point improvement from baseline at Day 30 on FLO-11 questionnaire Item 2 for GL
    • Secondary: The proportion of participants with a > 4-point improvement from baseline at Day 30 on FLO-11 questionnaire Item 5 for GL
    • Secondary: Incidence of adverse events; change from baseline in vital sign and ECG parameters; and presence of binding and neutralizing antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 30 and Day 60
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open label during the retreatment period
    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 EEA4
    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
    Belgium
    Russian Federation
    United States
    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
    LPLV
    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 months4
    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 months1
    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: 216
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 225
    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)
    Participants completing this study will be eligible to enroll into a 2-year open-label extension study to further assess long-term safety, efficacy, and immunogenicity.
    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 Decision2019-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-25
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