AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines

Allergan

Status and phase: Completed; Phase 2

Conditions: Glabellar Lines

Treatments: Drug: Placebo; Drug: AGN-151586

Study type: Interventional

Funder types: Industry

Identifiers

NCT04096326

2034-201-008

Details and patient eligibility

About

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).

Enrollment: 198 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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198 participants in 10 patient groups, including a placebo group

Cohort 1: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Cohort 1: AGN-151586

Experimental group

Description:

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

Treatment:

Drug: AGN-151586

Cohort 2: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Cohort 2: AGN-151586

Experimental group

Description:

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

Treatment:

Drug: AGN-151586

Cohort 3: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Cohort 3: AGN-151586

Experimental group

Description:

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

Treatment:

Drug: AGN-151586

Cohort 4: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Cohort 4: AGN-151586

Experimental group

Description:

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

Treatment:

Drug: AGN-151586

Cohort 5: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Cohort 5: AGN-151586

Experimental group

Description:

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

Treatment:

Drug: AGN-151586