AGN-151586 + OnabotulinumtoxinA for Frown Lines

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

126 Participants Needed

Trial Summary

What is the purpose of this trial?

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 participants with moderate to severe glabellar lines (GL).

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 the combination of AGN-151586 and OnabotulinumtoxinA safe for treating frown lines?

OnabotulinumtoxinA, used for treating facial lines, has been shown to be generally safe with a favorable benefit-risk profile, and is well tolerated by most patients. Some studies report minimal side effects, such as mild itching (pruritus), but these are rare. ^{1 2 3 4 5}

How is the drug combination of AGN-151586 and OnabotulinumtoxinA unique for treating frown lines?

The combination of AGN-151586 and OnabotulinumtoxinA for treating frown lines is unique because it potentially offers a novel approach by combining two agents, where OnabotulinumtoxinA is already known for its effectiveness in reducing frown lines, and AGN-151586 may enhance or complement this effect, although specific details about AGN-151586's role are not provided in the available research. ^{1 2 3 6 7}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines. [2018]

3. England 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. [2022]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Pruritus associated with onabotulinumtoxinA treatment of neuromuscular pain. [2018]

6. England 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. [2022]

7. New Zealand 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. [2021]