AGN-151586 + OnabotulinumtoxinA for Frown Lines

No longer recruiting at 7 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Active infection, Dermatological condition, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Single treatment

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of two treatments, AGN-151586 (an experimental treatment) and OnabotulinumtoxinA, for reducing moderate to severe frown lines between the eyebrows. Participants will receive either AGN-151586 at different doses combined with OnabotulinumtoxinA or a placebo (inactive substance) with OnabotulinumtoxinA. Individuals who often notice pronounced frown lines when squinting or frowning might be suitable for this study, provided they are generally healthy. As a Phase 1 trial, this research focuses on understanding how the new treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that OnabotulinumtoxinA, commonly known as Botox, is generally safe and well-tolerated. Studies have found it safe for treating facial lines, with most people not experiencing serious side effects. A thorough review confirmed that no new unwanted side effects have been linked to its use for frown lines and other facial areas.

Regarding AGN-151586, detailed safety information isn't available yet because it remains in early testing stages. At this point, the main goal is to assess its safety, so scientists closely monitor for any possible side effects. The study's existence suggests there is enough confidence to test its safety in humans. However, since it is an early phase trial, the complete safety profile is not yet known. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AGN-151586 combined with OnabotulinumtoxinA for treating frown lines because it introduces a potentially novel mechanism to enhance the effects of the well-known Botox (OnabotulinumtoxinA). While Botox is a standard treatment that temporarily paralyzes muscles to reduce wrinkles, AGN-151586 might work to enhance this effect, possibly offering longer-lasting results or improved efficacy. This combination could provide a new option for people seeking more effective and enduring solutions for reducing frown lines.

What evidence suggests that this trial's treatments could be effective for glabellar lines?

Research has shown that AGN-151586, when combined with OnabotulinumtoxinA (commonly known as BOTOX), might help reduce frown lines between the eyebrows. In this trial, participants will receive varying doses of AGN-151586 with OnabotulinumtoxinA or a placebo with OnabotulinumtoxinA to assess effectiveness. Studies have found that AGN-151586 outperforms a placebo in treating these lines, according to both doctors and patients. BOTOX is already widely used to smooth these lines by temporarily relaxing the muscles responsible for them. This combination is being tested to determine if it is more effective than BOTOX alone. Early results appear promising, but further research is necessary for confirmation. ^{2 3 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with moderate to severe frown lines who want to try new treatments. Participants should be healthy overall and not have any conditions that might interfere with the study or pose a risk when receiving injections in the face.

Inclusion Criteria

I have moderate to severe frown lines according to a wrinkle scale.

My overall health is good according to my doctor's evaluation.

Exclusion Criteria

I have an infection or skin condition where I will receive treatment injections.

History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients, and/or other products in the same class.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single treatment of AGN-151586 and OnabotulinumtoxinA

Single treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 10.4 months

What Are the Treatments Tested in This Trial?

Interventions

• AGN-151586
• OnabotulinumtoxinA

Trial Overview

The study is testing AGN-151586 and OnabotulinumtoxinA, comparing their safety and effectiveness in treating frown lines. Some participants will receive the actual drugs while others may get a placebo as part of the study's design.

How Is the Trial Designed?

Group I: Cohort 3: Placebo and OnabotulinumtoxinA Experimental Treatment 2 Interventions

Participants will receive a single treatment of Placebo and OnabotulinumtoxinA.

Group II: Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA Experimental Treatment 2 Interventions

Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.

Group III: Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA Experimental Treatment 2 Interventions

Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.

Group IV: Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA Experimental Treatment 2 Interventions

Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.

Group V: Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA Experimental Treatment 2 Interventions

Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.

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

Published Research Related to This Trial

A study comparing incobotulinumtoxinA and a higher dose of onabotulinumtoxinA (30 U) found no significant difference in effectiveness for treating glabellar frown lines, confirming that the standard 20 U dose is sufficient.

The research involved subjects aged 18-65 with moderate-to-severe frown lines, and assessments showed that increasing the dose of onabotulinumtoxinA did not provide any additional benefits over incobotulinumtoxinA at multiple time points up to 6 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IV study comparing incobotulinumtoxinA and onabotulinumtoxinA using a 1:1.5 dose-conversion ratio for the treatment of glabellar frown lines. Prager, W., Rappl, T.[2022]

OnabotulinumtoxinA is generally considered safe and effective for both cosmetic and medical treatments, with minimal adverse events reported.

A case study is presented where a patient experienced neuropathic pruritus five days after receiving onabotulinumtoxinA for neuromuscular pain, emphasizing the need for awareness and management of this potential side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pruritus associated with onabotulinumtoxinA treatment of neuromuscular pain. Ho, D., Jagdeo, J.[2018]

In a Phase III trial involving 105 participants, incobotulinumtoxinA demonstrated high efficacy for treating moderate-to-severe glabellar frown lines, with 98.1% of subjects showing improvement at Day 28 and 80.0% at Day 84.

The treatment was well tolerated, with a low incidence of adverse events and no development of neutralizing antibodies, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. Imhof, M., Kühne, U.[2021]

IncobotulinumtoxinA showed a faster onset of treatment effect for glabellar frown lines compared to onabotulinumtoxinA and abobotulinumtoxinA, with female subjects experiencing effects as early as 3.02 days after treatment.

The duration of the treatment effect was also longer for incobotulinumtoxinA than for the other two preparations, indicating it may provide more sustained results for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Onset and duration of effect of incobotulinumtoxinA, onabotulinumtoxinA, and abobotulinumtoxinA in the treatment of glabellar frown lines: a randomized, double-blind study. Rappl, T., Parvizi, D., Friedl, H., et al.[2021]

A meta-analysis of 1678 participants from multiple studies confirmed that onabotulinumtoxinA is safe and well-tolerated for treating facial lines, with no significant difference in overall adverse event incidence compared to placebo.

The most common treatment-related adverse events were mild to moderate, including eyelid sensory disorder and eyelid ptosis, but these were infrequent and decreased with repeated treatments, indicating a favorable long-term safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: a meta-analysis of individual patient data from global clinical registration studies in 1678 participants. Brin, MF., Boodhoo, TI., Pogoda, JM., et al.[2022]

In a 48-week study involving 226 women, higher doses of onabotulinumtoxinA (40, 60, and 80 U) significantly improved the severity of glabellar lines compared to the standard 20 U dose, with responder rates at Week 24 being 16.0% for 20 U and up to 38.5% for 80 U.

The higher doses not only provided a longer duration of response (≥24.0 weeks for higher doses vs. 19.7 weeks for 20 U) but also resulted in higher patient satisfaction without increasing the incidence of adverse events, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines. Joseph, JH., Maas, C., Palm, MD., et al.[2022]

In a study involving 250 females, incobotulinumtoxinA and onabotulinumtoxinA were found to be equivalent in effectiveness for treating glabellar frown lines at a dose of 20 units, with results remaining consistent for up to 4 months.

Both treatments were well tolerated, with over 90% patient satisfaction reported, indicating that both options are safe and effective for improving the appearance of frown lines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines. Kane, MA., Gold, MH., Coleman, WP., et al.[2018]

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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 of ...

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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 of ...

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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 ...