AGN-151586 for Frown Lines

No longer recruiting at 52 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must not be taking: Botulinum neurotoxin

Disqualifiers: Uncontrolled systemic disease, Myasthenia gravis, Facial nerve palsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AGN-151586, an experimental therapy for improving glabellar lines (the frown lines between the eyebrows). The main goal is to assess the safety of this treatment when administered multiple times. Adults with moderate to severe glabellar lines, who can see their lines clearly without glasses and have not recently received related treatments, might be suitable candidates. Participants will receive injections and attend regular check-ups to monitor effects and any side effects. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have used any botulinum neurotoxin for aesthetic treatment in the last 6 months or for therapeutic treatment in the last 12 months, you may not be eligible to participate.

Is there any evidence suggesting that AGN-151586 is likely to be safe for humans?

Research shows that AGN-151586 is generally safe. Earlier studies found no harmful reactions directly linked to AGN-151586. When side effects occurred, they were usually mild to moderate and resolved on their own, indicating that most people tolerated the treatment well.

AGN-151586 is administered as an injection into the muscle. This method involves injecting the medicine directly into the muscle, a common practice for treatments of this kind.

Overall, research suggests that AGN-151586 is safe for humans, based on earlier study findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AGN-151586 is unique because it targets glabellar lines, the frown lines between your eyebrows, using a novel formulation. Unlike traditional treatments like Botox, which also work on these lines, AGN-151586 is delivered via intramuscular injections, potentially offering a different safety and efficacy profile. Researchers are particularly excited because this new approach might provide longer-lasting results or fewer side effects, improving patient outcomes and satisfaction.

What evidence suggests that AGN-151586 might be an effective treatment for glabellar lines?

Research has shown that AGN-151586, which participants in this trial will receive, may help reduce frown lines between the eyebrows, known as glabellar lines. In earlier studies, individuals who received AGN-151586 injections noticed a clear improvement in these lines compared to those who received a placebo. The treatment relaxes certain forehead muscles, smoothing out the lines. Evidence also indicates that the treatment is generally safe, with manageable side effects. Overall, these findings suggest that AGN-151586 could effectively reduce moderate to severe frown lines. ^{2 6 7 8 9}

Who Is on the Research Team?

ALLERGAN INC.

Principal Investigator

Allergan

Are You a Good Fit for This Trial?

Inclusion Criteria

You need to be able to see your facial lines without eyeglasses, but wearing contact lenses is allowed.

You have moderate or severe Glabellar Lines at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline Day 1 visit.

Exclusion Criteria

Presence or history of any medical condition that may place the subject at increased risk following exposure to AGN-151586 or interfere with the study evaluation, including: Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function History of facial nerve palsy Infection or dermatological condition at the treatment injection sites Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart Any eyebrow or eyelid ptosis at screening or Baseline Day 1 visit as determined by the investigator History of known immunization to any botulinum toxin serotype. Participants who have reported use of any botulinum neurotoxin of any serotype (including any investigational botulinum neurotoxin product) for aesthetic treatment within the last 6 months prior to screening and for therapeutic treatment within the last 12 months prior to study drug administration. Tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed. Anticipated need for surgery or overnight hospitalization during the study. History of surgical procedures on forehead and/or periorbital areas or affecting these areas including any lifting procedure (e.g., rhinoplasty, facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery). History of periorbital, mid-facial, or upper-facial treatment with semi-permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation. Known active severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection. Female subject who is pregnant or breastfeeding, and is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer. Participant who has been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study. Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).

You have a disease that is not under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 intramuscular AGN-151586 injections to the glabellar complex on Day 1, with potential for up to 2 additional cycles based on retreatment criteria

18 weeks

Regular visits at study site

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for adverse events and immunogenicity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AGN-151586

How Is the Trial Designed?

Group I: AGN-151586 Experimental Treatment 1 Intervention

Participants will receive 5 intramuscular injections in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may receive up to 2 additional cycles of open-label treatments.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

Citations

1. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M23-365

A Study to Evaluate Sequential Administration of AGN ... A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06308198

NCT06308198 | A Study to Evaluate AGN-151586 ... The purpose of this study is to evaluate the safety and efficacy of AGN-151586 compared to placebo in adult participants.

3. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2021-003667-10/results

EudraCT Number 2021-003667-10 - Clinical trial results The purpose of this study was to evaluate the safety and efficacy of AGN-151586 for the treatment of glabellar lines (GL) in participants ...

4. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M21-500

A Study to Assess Adverse Events and Change in Disease ... A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines · Study Details.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06151561

Study of AGN-151586 in Japanese Participants With ... Study of AGN-151586 in Japanese Participants With Moderate to Severe Glabellar Lines ... The purpose of this study is to evaluate the safety and efficacy of AGN ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/67/NCT05248867/Prot_000.pdf

Prot_000.pdf Based on the Phase 2b Study results, there are no known adverse drug reactions (ADRs) for. AGN-151586. Since AGN-151586 is given as an intramuscular injection, ...

7. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M21-509

A Study to Assess Adverse Events of Intramuscular AGN- ... The purpose of this study is to evaluate the safety of AGN-151586 over multiple repeat treatments of the study drug to improve the appearance of glabellar ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06834789/a-study-to-assess-the-adverse-events-of-intramuscular-injections-of-agn-151586-and-onabotulinumtoxina-in-adult-participants-for-the-change-of-glabellar-lines-gl?state=CA&city=Newport%20Beach

A Study to Assess the Adverse Events of Intramuscular ... The objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex.

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/26/NCT04096326/Prot_000.pdf

Title Page These adverse events were mild to moderate in severity and resolved. The adverse event profile associated with AGN-151586 showed no unusual findings; no safety ...