80 Participants Needed

Lebrikizumab for Eczema

(ADmirable Trial)

Recruiting at 60 trial locations
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Providers - Howard Sofen, MD.
Overseen ByHoward Sofen
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial is testing lebrikizumab, a medication that reduces inflammation, in adolescents and adults with severe eczema and skin of color. The goal is to see if it is safe and effective for these patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting. You must stop using topical agents like corticosteroids and JAK inhibitors 2 weeks before the trial, and systemic immunosuppressive drugs and JAK inhibitors 4 weeks before the trial.

What data supports the effectiveness of the drug Lebrikizumab for eczema?

Research shows that Lebrikizumab, a drug targeting a protein called interleukin-13, is effective in treating moderate-to-severe eczema (atopic dermatitis). In clinical trials, many patients experienced significant improvements in their skin condition and itchiness, with a good safety profile.12345

Is lebrikizumab safe for treating eczema?

Lebrikizumab has been shown to be generally safe in clinical trials for treating moderate-to-severe eczema, with most patients experiencing no significant side effects. Common mild side effects reported include conjunctivitis (eye inflammation), nasopharyngitis (cold-like symptoms), and headache.12345

How is the drug lebrikizumab different from other treatments for eczema?

Lebrikizumab is unique because it specifically targets interleukin-13 (IL-13), a protein involved in the inflammation process of eczema, offering a targeted approach to treatment. It is administered as an injection every four weeks, which may be more convenient compared to other treatments that require more frequent dosing.12456

Research Team

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults and adolescents (12 years and older) with moderate-to-severe atopic dermatitis, specifically those with skin of color (Fitzpatrick phototype IV-VI). Participants should have a history of inadequate response to topical treatments. Women must use effective contraception or remain abstinent, while men's requirements vary by location.

Inclusion Criteria

Are willing and able to comply with all clinic visits and study-related procedures and questionnaires.
My weight is at least 40 kg.
Your Eczema Area and Severity Index (EASI) score is 16 or higher at the beginning of the study.
See 10 more

Exclusion Criteria

I have liver cirrhosis or chronic hepatitis.
I haven't used any skin creams or ointments for my condition in the last 2 weeks.
I haven't had cancer, except for specific skin cancers or cervical cancer that were fully treated, in the last 5 years.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lebrikizumab subcutaneously for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Lebrikizumab
Trial OverviewThe study tests the safety and effectiveness of Lebrikizumab in treating atopic dermatitis among individuals with darker skin tones. It aims to see if this medication can improve their condition when other treatments haven't worked well enough.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: LebrikizumabExperimental Treatment1 Intervention
Participants will receive Lebrikizumab subcutaneously (SC).

Lebrikizumab is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Ebglyss for:
  • Moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg
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Approved in United States as Ebglyss for:
  • Moderate-to-severe atopic dermatitis in adults and children 12 years and older who weigh at least 88 pounds (40 kg)
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Approved in Canada as Ebglyss for:
  • Moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

Lebrikizumab, a targeted therapy for moderate-to-severe atopic dermatitis (AD), has shown significant efficacy in clinical trials, improving key measures like the Eczema Area and Severity Index and pruritus scores.
The treatment has a favorable safety profile, with most patients experiencing no significant adverse events, making it a promising option for managing AD.
Lebrikizumab for the Treatment of Moderate-to-Severe Atopic Dermatitis.Bernardo, D., Bieber, T., Torres, T.[2023]
In a phase III trial, 74% of adults with moderate to severe atopic dermatitis (AD) treated with lebrikizumab 250 mg every 4 weeks showed significant improvement, achieving an Investigator Global Assessment score of 0/1, indicating effective treatment.
Lebrikizumab was associated with relatively mild side effects, with common adverse effects including conjunctivitis (7-8%), nasopharyngitis (4-5%), and headache (3-5%), suggesting it may be a safe long-term option for AD management.
The role of lebrikizumab in the treatment of atopic dermatitis in the adult population.Prajapati, S., Fardos, M., Desai, AD., et al.[2023]
Lebrikizumab, an IL-13 immunomodulator, significantly improved symptoms of moderate-to-severe atopic dermatitis (AD) compared to placebo, with notable enhancements in Eczema Area and Severity Index (EASI), Body Surface Area (BSA), and Investigator's Global Assessment (IGA) after 16 weeks in a study involving 1,149 participants.
The treatment was found to be safe, showing no significant increase in serious adverse events (SAEs), non-serious adverse events (NSAEs), or mortality, indicating that lebrikizumab is a promising option for managing AD with a high certainty of evidence.
The efficacy and safety of lebrikizumab monotherapy for the management of moderate-to-severe atopic dermatitis: A systematic review and meta-analysis.Bashrahil, B., Alzahrani, Z., Samarkandy, S., et al.[2023]

References

Lebrikizumab for the Treatment of Moderate-to-Severe Atopic Dermatitis. [2023]
The role of lebrikizumab in the treatment of atopic dermatitis in the adult population. [2023]
The efficacy and safety of lebrikizumab monotherapy for the management of moderate-to-severe atopic dermatitis: A systematic review and meta-analysis. [2023]
Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere). [2023]
Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study. [2023]
Matching-Adjusted Indirect Comparison of the Long-Term Efficacy Maintenance and Adverse Event Rates of Lebrikizumab versus Dupilumab in Moderate-to-Severe Atopic Dermatitis. [2023]