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NCT05248880 · ClinicalTrials.gov registry record · Phase 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
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 309
- Enrollment target
NCT05248880 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 309 participants.
The verdict
NCT05248880, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 309 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG AGN-151586
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2022-03-08 |
| Est. Completion | 2023-02-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05248880
The ClinicalTrials.gov registry entry for NCT05248880 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05248880 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05248880 about?
NCT05248880 is a clinical study titled "A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines". 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 stu...
What is the current status of trial NCT05248880?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2022-03-08. Estimated completion is 2023-02-01.
What interventions are being tested in trial NCT05248880?
The interventions under investigation include: Placebo (DRUG), AGN-151586 (DRUG).
Who is sponsoring clinical trial NCT05248880?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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