M21-500 A Phase 3 study for the treatment of Glabellar Lines
Research type
Research Study
Full title
A Phase 3, Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines
IRAS ID
1004637
Contact name
Aleksandra Jankielewicz
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2021-003667-10
Clinicaltrials.gov Identifier
Research summary
Facial lines that develop from repeated facial expression, such as glabellar lines
(GL), are typically treated by selectively weakening specific muscles with small quanti-ties 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 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 600 adult partici-pants with moderate to severe GL will be enrolled in the study in approximately 38 sites across the world.
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 effectsREC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0165
Date of REC Opinion
10 Oct 2022
REC opinion
Further Information Favourable Opinion