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NCT05248867 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 638
- Enrollment target
NCT05248867 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 638 participants.
The verdict
NCT05248867, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 638 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 was to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in participants with moderate to severe GL. This was a 12-week study in which eligible subjects were enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants were randomly assigned to receive AGN-151586 or placebo. There was 1 in a 4 chance that participants would receive placebo. Around 600 adult participants with moderate to severe GL were to be enrolled in the study in approximately 38 sites across the world. Participants received either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may have received an open-label treatment of AGN-151586 during the study. Participants attended regular visits during the study at a study site. The effect of the treatment was 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 | 638 participants |
| Start Date | 2022-03-16 |
| Est. Completion | 2023-03-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05248867
The ClinicalTrials.gov registry entry for NCT05248867 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 638 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.
NCT05248867 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05248867 about?
NCT05248867 is a clinical study titled "A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in 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 NCT05248867?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 638 participants. The study started on 2022-03-16. Estimated completion is 2023-03-17.
What interventions are being tested in trial NCT05248867?
The interventions under investigation include: Placebo (DRUG), AGN-151586 (DRUG).
Who is sponsoring clinical trial NCT05248867?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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