A Study to Assess the Safety and Efficacy of AGN-151586 Injections for the Treatment of Moderate to Severe Forehead Lines (FHL) in Adult Participants

NCT07730554 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: M26-476
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the safety and efficacy of AGN-151586 for the treatment of moderate to severe forehead lines (FHL) in adult participants.

Conditions

Forehead Lines

Keywords

Forehead Lines; AGN-151586; TrenibotulinumtoxinE

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to Approximately 42 Days

Study Arms (1)

Open-Label AGN-151586

EXPERIMENTAL

Participants will receive a single treatment of AGN-151586 on Day 1.

Drug: AGN-151586

Interventions

AGN-151586 DRUG

Injection

Open-Label AGN-151586

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have moderate (Grade 2) or severe (Grade 3) forehead lines (FHL) at maximum eyebrow elevation as assessed by the subject and investigator using Forehead Lines Severity Scale (FHLSS) at Screening visit and Baseline Day 1 visit.
• Participant must have moderate (Grade 2) or severe (Grade 3) glabellar lines (GL) at maximum frown as assessed by the subject and investigator using Allergan Glabellar Lines Severity Scale (AGLSS) at Screening visit and Baseline Day 1 visit.
• Sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their FHL and GL in investigator's opinion.

You may not qualify if:

• Clinically relevant or significant ECG abnormalities.
• Active infection or dermatological condition at any of the treatment injection sites.

Sponsors & Collaborators

• AbbVie: lead

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/