CompletedPhase 3

A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines

United States309 participantsStarted 2022-03-08

Plain-language summary

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. AGN-151586 is an investigational product being developed for the treatment of GL. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in toxin-naïve participants with moderate to severe GL. This is a 12 week study in which eligible subjects will be enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 300 adult participants with moderate to severe GL will be enrolled in the study in approximately 15 sites. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive an open-label treatment of AGN-151586 during the study. Participants 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must be able to accurately assess their facial lines without the use of eyeglasses (contact lens use is acceptable). * 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. Exclusion Criteria: * Uncontrolled systemic disease. * Participants must not have a history of any use of botulinum neurotoxin of any serotype for any indication (including any investigational botulinum neurotoxin product). * Presence or history of any medical condition that may place the participant at increased risk following exposure to AGN-151586 or interfere with the study evaluation, including: * Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function * History of facial nerve palsy * Infection or dermatological condition at the treatment injection sites * 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 * Any eyebrow or eyelid ptosis at screening or Baseline Day 1 visit as determined by the investigator * History of known immunization to any botulinum neurotoxin serotype. * Tattoos, jewelry, or clothing which obscure the glabe…

What they're measuring

Percentage of Participants With a Grade 0 or 1 and a ≥ 2-grade Improvement From Baseline on the FWS According to Both Investigator and Subject Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [US FDA]

Timeframe: Baseline, Day 7 (Double-blind period)

Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Participant Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]

Timeframe: Baseline, Day 7 (Double-blind period)

Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the FWS According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown at Day 7 [European Union Regulatory Agencies]

Timeframe: Baseline, Day 7 (Double-blind Period)

Number of Participants With Adverse Events

Timeframe: From time of informed consent to end of study; median time on follow-up was 85 days for all groups.

Trial details

NCT IDNCT05248880

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-01

Results submitted2026-01-05

View on ClinicalTrials.gov More Glabellar Lines trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: Baseline, Day 7 (Double-blind period)

Timeframe: Baseline, Day 7 (Double-blind Period)

Number of Participants With Adverse Events

Timeframe: From time of informed consent to end of study; median time on follow-up was 85 days for all groups.