AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines
A Phase 2b Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of AGN-151586 in Participants With Moderate to Severe Glabellar Lines
1 other identifier
interventional
198
1 country
9
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range of doses for the treatment of moderate to severe glabellar lines (GL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2019
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2019
CompletedFirst Posted
Study publicly available on registry
September 19, 2019
CompletedStudy Start
First participant enrolled
September 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2020
CompletedResults Posted
Study results publicly available
July 28, 2023
CompletedJuly 28, 2023
July 1, 2023
12 months
September 4, 2019
July 10, 2023
July 10, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7
Percentage of participants achieving a ≥ 2-grade improvement from baseline on the FWS according to investigator assessments of GL severity at maximum frown at any postintervention timepoint through Day 7 were reported. Investigators' assessments of the severity of GL at rest and maximum frown using the validated FWS was assessed using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Baseline (Day 1) through Day 7
Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were defined as events event began on or after the date and time of the study intervention; or the adverse event was present before the date and time of the study intervention, but increased in severity or became serious on or after the date and time of the study intervention.
From first dose of study drug until the end of study (up to 42 days)
Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention
Potentially clinically significant post intervention laboratory values included hematology, chemistry, and urinalysis as defined in the SAP.
From first dose of study drug until the end of study (up to 42 days)
Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention
Potentially clinically significant post intervention vital sign measurements included systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as defined in the SAP.
From first dose of study drug until the end of study (up to 42 days)
Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention
Potentially clinically significant post intervention values in 12-lead ECG recordings included heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semi-supine or supine position as defined in the SAP. A post-baseline value is considered potentially clinically significant if it meets either the observed-value or the change-from-baseline criteria such as QRS interval observed value: ≥ 150 msec; PR interval observed value: ≥ 250 msec; QTcB observed value: \> 500 msec or change from baseline value: increase of \> 60 msec; QTcF observed value: \> 500 msec or change from baseline value: increase of \> 60 msec.
From first dose of study drug until the end of study (up to 42 days)
Number of Participants With Anti-drug Antibodies (ADAs)
Number of participants with positive anti-drug antibodies are reported. Binding and neutralizing anti-bodies are evaluated as anti-drug antibodies. Only participants with positive samples for binding antibodies have been analyzed for presence of neutralizing antibodies.
Up to Day 42
Study Arms (10)
Cohort 1: Placebo
PLACEBO COMPARATORParticipants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.
Cohort 1: AGN-151586
EXPERIMENTALParticipants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
Cohort 2: Placebo
PLACEBO COMPARATORParticipants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.
Cohort 2: AGN-151586
EXPERIMENTALParticipants received AGN-151586, IM injections in the glabellar complex on Day 1.
Cohort 3: Placebo
PLACEBO COMPARATORParticipants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.
Cohort 3: AGN-151586
EXPERIMENTALParticipants received AGN-151586, IM injections in the glabellar complex on Day 1.
Cohort 4: Placebo
PLACEBO COMPARATORParticipants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.
Cohort 4: AGN-151586
EXPERIMENTALParticipants received AGN-151586, IM injections in the glabellar complex on Day 1.
Cohort 5: Placebo
PLACEBO COMPARATORParticipants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.
Cohort 5: AGN-151586
EXPERIMENTALParticipants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.
Interventions
AGN-151586 solution for injection.
Placebo solution for injection.
Eligibility Criteria
You may qualify if:
- Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period (at least 10 weeks after study intervention).
You may not qualify if:
- Known immunization or hypersensitivity to any botulinum neurotoxin serotype
- Any medical condition that may put the participant at increased risk with exposure to AGN-151586, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- 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
- Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study intervention)
- Anticipated need for surgery or overnight hospitalization during the study
- 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 Screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (9)
Center for Dermatology Clinical Research /ID# 237798
Fremont, California, 94538, United States
Ava T. Shamban MD - Santa Monica. /ID# 235353
Santa Monica, California, 90404-2208, United States
Skin and Cancer Associates, LLP /ID# 236231
Miami, Florida, 33137-3254, United States
Laser and Skin Surgery Center of Indiana /ID# 236588
Indianapolis, Indiana, 46260-2386, United States
Wilmington Dermatology Center /ID# 237055
Wilmington, North Carolina, 28403, United States
Kgl, Llc /Id# 234798
Newtown Square, Pennsylvania, 19073-2228, United States
DermResearch Inc. /ID# 234483
Austin, Texas, 78759, United States
Austin Institute for Clinical Research at SBA Dermatology /ID# 236646
Houston, Texas, 77056-4129, United States
Austin Institute for Clinical Research /ID# 237135
Pflugerville, Texas, 78660, United States
Related Links
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ALLERGAN INC.
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2019
First Posted
September 19, 2019
Study Start
September 26, 2019
Primary Completion
September 9, 2020
Study Completion
September 9, 2020
Last Updated
July 28, 2023
Results First Posted
July 28, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- 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/
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.