This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.

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

    global-clinical-trials@abbvie.com

  • Sponsor organisation

    AbbVie Deutschland GmbH & Co. KG

  • Eudract number

    2021-003667-10

  • Clinicaltrials.gov Identifier

    NCT05248867

  • 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 effects

  • REC 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

Shape the future of the HRA website.