Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-27 @ 1:47 AM
Study NCT ID:
NCT05248893
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2022-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 986}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'dispFirstSubmitDate': '2024-05-28', 'completionDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2022-02-14', 'studyFirstSubmitQcDate': '2022-02-14', 'dispFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'Day 1 to Day 126', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.'}, {'measure': 'Change in Vital Sign Measurements', 'timeFrame': 'Day 1 to Day 126', 'description': 'Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.'}, {'measure': 'Change in Electrocardiogram (ECG) Measurements', 'timeFrame': 'Day 1 to Day 126', 'description': "12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF)."}, {'measure': 'Presence of binding and neutralizing antidrug antibodies', 'timeFrame': 'Day 1 to Day 126', 'description': 'Blood samples for immunogenicity testing will be collected from all participants treated with AGN-151586 at predetermined timepoints. Collected samples will be processed to yield serum for detection of binding and neutralizing antibodies to AGN-151586.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glabellar Lines', 'AGN-151586'], 'conditions': ['Glabellar Lines']}, 'descriptionModule': {'briefSummary': 'Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety of AGN-151586 over multiple repeat treatments of the study drug to improve the appearance of glabellar lines.\n\nAGN-151586 is an investigational product being developed for the treatment of GL. Around 940 to 1100 adult participants with moderate to severe GL will be enrolled in the study in approximately 45 sites in the United States.\n\nThis is an open-label, 126 day study in which all participants will receive 5 intramuscular AGN-151586 injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive up to 2 additional cycles of treatment during the study.\n\nParticipants will attend regular visits during the study at a study site. The effect of the treatment will be checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be able to accurately assess their facial lines without the use of eyeglasses (contact lens use is acceptable).\n* Participant must have moderate or severe Glabellar Lines at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline Day 1 visit.\n\nExclusion Criteria:\n\n* Uncontrolled systemic disease.\n* Presence or 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:\n\n * Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function\n * History of facial nerve palsy\n * Infection or dermatological condition at the treatment injection sites\n * 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\n * Any eyebrow or eyelid ptosis at screening or Baseline Day 1 visit as determined by the investigator\n* History of known immunization to any botulinum toxin serotype.\n* Participants who have reported use of any botulinum neurotoxin of any serotype (including any investigational botulinum neurotoxin product) for aesthetic treatment within the last 6 months prior to screening and for therapeutic treatment within the last 12 months prior to study drug administration.\n* Tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed.\n* Anticipated need for surgery or overnight hospitalization during the study.\n* 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).\n* 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.\n* Known active severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection.\n* Female subject who is pregnant or breastfeeding, and is 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.\n* Participant who has been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.\n* Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).'}, 'identificationModule': {'nctId': 'NCT05248893', 'briefTitle': 'A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3, Multicenter, Open-label Study to Evaluate the Safety of AGN-151586 for the Treatment of Glabellar Lines', 'orgStudyIdInfo': {'id': 'M21-509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AGN-151586', 'description': 'Participants will receive 5 intramuscular injections in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may receive up to 2 additional cycles of open-label treatments.', 'interventionNames': ['Drug: AGN-151586']}], 'interventions': [{'name': 'AGN-151586', 'type': 'DRUG', 'description': 'Intramuscular Injection', 'armGroupLabels': ['AGN-151586']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209-8314', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Skin Wellness Dermatology - Homewood /ID# 241233', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Advanced Research Associates - Glendale /ID# 232245', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Skin Care and Laser Physicians of Beverly Hills /ID# 241237', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663-3637', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'The Eye Research Foundation /ID# 232229', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92121-2119', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Cosmetic Laser Dermatology /ID# 243513', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92122-1013', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Health - University Center Lane - La Jolla /ID# 241243', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404-2208', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Ava T. Shamban MD - Santa Monica. /ID# 241246', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '92075-2228', 'city': 'Solana Beach', 'state': 'California', 'country': 'United States', 'facility': 'Art of Skin MD /ID# 241244', 'geoPoint': {'lat': 32.99115, 'lon': -117.27115}}, {'zip': '92083-6030', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Moradi MD /ID# 241242', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'AboutSkin Research, LLC /ID# 241702', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '34209-5642', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Susan H. Weinkle MD /ID# 233835', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33146-1837', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Skin Research Institute LLC /ID# 232240', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33137-3254', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Skin and Cancer Associates, LLP /ID# 232228', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33613-1244', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'ForCare Clinical Research /ID# 241229', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30022', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Hamilton Research, LLC /ID# 241232', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '30331-2160', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Biomedical Clinical Research /ID# 241258', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31406-2632', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Meridian Clinical Research Dermatology /ID# 241234', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'DeNova Research /ID# 232231', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60069', 'city': 'Lincolnshire', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advanced Dermatology /ID# 241252', 'geoPoint': {'lat': 42.19002, 'lon': -87.9084}}, {'zip': '46260-2386', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Laser and Skin Surgery Center of Indiana /ID# 233834', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Coleman Center For Cosmetic Dermatologic Surgery /ID# 232230', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70130-4353', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Etre Cosmetic Dermatology and Laser Center /ID# 232235', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '20774-5341', 'city': 'Largo', 'state': 'Maryland', 'country': 'United States', 'facility': 'Visage Dermatology and Aesthetic Center /ID# 241248', 'geoPoint': {'lat': 38.89761, 'lon': -76.83025}}, {'zip': '20852-3093', 'city': 'North Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Rkmd, Llc /Id# 241239', 'geoPoint': {'lat': 39.04455, 'lon': -77.11887}}, {'zip': '48346', 'city': 'Clarkston', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Center for Research Company /ID# 241255', 'geoPoint': {'lat': 42.73586, 'lon': -83.41883}}, {'zip': '07716-1241', 'city': 'Atlantic Highlands', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rao Dermatology /ID# 243515', 'geoPoint': {'lat': 40.40789, 'lon': -74.03431}}, {'zip': '07042', 'city': 'Montclair', 'state': 'New Jersey', 'country': 'United States', 'facility': 'image Dermatology, P.C. /ID# 241227', 'geoPoint': {'lat': 40.82593, 'lon': -74.20903}}, {'zip': '12110', 'city': 'Latham', 'state': 'New York', 'country': 'United States', 'facility': 'The Rejuva Center /ID# 244285', 'geoPoint': {'lat': 42.74702, 'lon': -73.75901}}, {'zip': '11795-4916', 'city': 'West Islip', 'state': 'New York', 'country': 'United States', 'facility': 'Mariwalla Dermatology /ID# 241240', 'geoPoint': {'lat': 40.70621, 'lon': -73.30623}}, {'zip': '97210-2859', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Northwest Dermatology Institute /ID# 233498', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104-5127', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Perelman Center for Advanced Medicine - /ID# 243966', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37205-2205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sherman Aesthetic Center /ID# 241247', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37215-2885', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center /ID# 241254', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc. Austin, TX /ID# 241228', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Bellaire Dermatology Associates /ID# 232243', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '77845-3898', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'J&S Studies, Inc. /ID# 241236', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '75225-6203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Center for Dermatology and Aesthetics /ID# 241245', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84117-4209', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Swinyer-Woseth Dermatology /ID# 241250', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '24501-1403', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Education & Research Foundation, Inc. /ID# 241225', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Premier Clinical Research /ID# 233836', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53005', 'city': 'Brookfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'EthiQ2 Research, LLC /ID# 241256', 'geoPoint': {'lat': 43.06057, 'lon': -88.10648}}, {'zip': '00961-6910', 'city': 'Bayamón', 'country': 'Puerto Rico', 'facility': 'Santa Cruz Behavioral (SCB) Research Center /ID# 241226', 'geoPoint': {'lat': 18.39856, 'lon': -66.15572}}, {'zip': '00917', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 241241', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'ALLERGAN INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}