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Clinical Trials/NCT04096326
NCT04096326CompletedPhase 2

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

Allergan9 sites in 1 country198 target enrollmentStarted: September 26, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Allergan
Enrollment
198
Locations
9
Primary Endpoint
Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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

Arms & Interventions

Cohort 1: Placebo

Placebo Comparator

Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.

Intervention: Placebo (Drug)

Cohort 1: AGN-151586

Experimental

Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.

Intervention: AGN-151586 (Drug)

Cohort 2: Placebo

Placebo Comparator

Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.

Intervention: Placebo (Drug)

Cohort 2: AGN-151586

Experimental

Participants received AGN-151586, IM injections in the glabellar complex on Day 1.

Intervention: AGN-151586 (Drug)

Cohort 3: Placebo

Placebo Comparator

Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.

Intervention: Placebo (Drug)

Cohort 3: AGN-151586

Experimental

Participants received AGN-151586, IM injections in the glabellar complex on Day 1.

Intervention: AGN-151586 (Drug)

Cohort 4: Placebo

Placebo Comparator

Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.

Intervention: Placebo (Drug)

Cohort 4: AGN-151586

Experimental

Participants received AGN-151586, IM injections in the glabellar complex on Day 1.

Intervention: AGN-151586 (Drug)

Cohort 5: Placebo

Placebo Comparator

Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.

Intervention: Placebo (Drug)

Cohort 5: AGN-151586

Experimental

Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.

Intervention: AGN-151586 (Drug)

Outcomes

Primary Outcomes

Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7

Time Frame: Baseline (Day 1) 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.

Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs)

Time Frame: From first dose of study drug until the end of study (up to 42 days)

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.

Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention

Time Frame: From first dose of study drug until the end of study (up to 42 days)

Potentially clinically significant post intervention laboratory values included hematology, chemistry, and urinalysis as defined in the SAP.

Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention

Time Frame: From first dose of study drug until the end of study (up to 42 days)

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.

Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention

Time Frame: From first dose of study drug until the end of study (up to 42 days)

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.

Number of Participants With Anti-drug Antibodies (ADAs)

Time Frame: Up to Day 42

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Allergan
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (9)

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