Lebrikizumab for Eczema

(ADmirable Trial)

No longer recruiting at 61 trial locations

Overseen By Howard Sofen

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Systemic corticosteroids, JAK inhibitors

Disqualifiers: HIV, Hepatitis B, Hepatitis C, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of lebrikizumab, a treatment for moderate-to-severe eczema (atopic dermatitis) in people with different skin tones. The researchers aim to determine how well this treatment works for those who have struggled with eczema for over a year without success using creams or ointments. It suits individuals with eczema covering at least 10% of their body and who are of a non-White race, including Black, Asian, or Pacific Islander backgrounds. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for eczema.

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.

Is there any evidence suggesting that lebrikizumab is likely to be safe for humans?

Research has shown that lebrikizumab is generally safe for individuals with moderate-to-severe eczema, also known as atopic dermatitis. One study found that people using lebrikizumab for up to two years experienced ongoing improvements in their skin condition, with about 80% continuing to see significant skin improvements.

Although this treatment is not approved for children under 12, it is available for older children and adults. Safety information from these studies suggests that most people can use lebrikizumab without serious side effects. However, discussing potential risks with a healthcare provider before joining a clinical trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Lebrikizumab is unique because it targets a specific protein called IL-13, which plays a crucial role in the inflammation seen in eczema. Unlike traditional treatments like corticosteroids or calcineurin inhibitors that broadly suppress the immune system, Lebrikizumab offers a more targeted approach, potentially reducing side effects. Researchers are excited because this precision in targeting IL-13 could lead to more effective and longer-lasting relief for people with eczema, offering a new hope for those who haven't found success with existing therapies.

What evidence suggests that lebrikizumab might be an effective treatment for atopic dermatitis?

Research shows that lebrikizumab effectively treats moderate-to-severe atopic dermatitis (AD), a type of eczema. Studies have found that it reduces AD symptoms, such as itching and skin rashes, even in people with various skin tones. In trials lasting up to two years, patients experienced less itching and clearer skin. The treatment's benefits persisted, making it a promising option for managing AD. Overall, lebrikizumab could enhance the quality of life for those with this condition. ^{3 6 7 8 9}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lebrikizumab

Trial Overview The 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.

How Is the Trial Designed?

Group I: Lebrikizumab 250 mg Q2W Experimental Treatment 1 Intervention

Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16.

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

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)

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

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Lebrikizumab administered every 4 weeks was found to be more effective in maintaining low disease activity (IGA 0/1) over a 36-week period compared to dupilumab given weekly or every 2 weeks, indicating a potential advantage in long-term treatment adherence.

Both lebrikizumab and dupilumab showed similar efficacy in terms of overall skin improvement (EASI-75) and had comparable rates of adverse events, suggesting that lebrikizumab may offer a more convenient dosing schedule without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matching-Adjusted Indirect Comparison of the Long-Term Efficacy Maintenance and Adverse Event Rates of Lebrikizumab versus Dupilumab in Moderate-to-Severe Atopic Dermatitis. Rand, K., Ramos-Goñi, JM., Akmaz, B., et al.[2023]

In a 52-week Phase 3 study involving 206 adolescents with moderate-to-severe atopic dermatitis, lebrikizumab demonstrated a favorable safety profile, with only 2.4% of patients experiencing serious adverse events and the same percentage discontinuing treatment due to adverse events.

Lebrikizumab significantly improved atopic dermatitis symptoms, with 62.6% of patients achieving a 2-point improvement in the Investigator's Global Assessment and 81.9% achieving at least a 75% improvement in the Eczema Area and Severity Index by Week 52.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study. Paller, AS., Flohr, C., Eichenfield, LF., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a phase 3 trial involving 211 patients with moderate-to-severe atopic dermatitis, lebrikizumab (LEB) combined with topical corticosteroids (TCS) significantly improved skin condition, with 41.2% of patients achieving a clear or almost clear skin score compared to 22.1% in the placebo group.

The safety profile of LEB was consistent with previous studies, with most adverse events being mild or moderate, and serious adverse events were similarly low in both the LEB and placebo groups, indicating that LEB is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Simpson, EL., Gooderham, M., Wollenberg, A., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lebrikizumab for the Treatment of Moderate-to-Severe Atopic Dermatitis. Bernardo, D., Bieber, T., Torres, T.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04146363

Study Details | NCT04146363 | Evaluation of the Efficacy ... The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40665146/

Results from the Phase IIIb, Open-Label ADmirable Study The aim of this study was to evaluate the efficacy and safety of lebrikizumab in adults and adolescents with skin of color and moderate-to-severe AD.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206714

Two Phase 3 Trials of Lebrikizumab for Moderate-to- ... We conducted two identically designed phase 3 trials, ADvocate1 and ADvocate2, to evaluate the efficacy and safety of lebrikizumab monotherapy in adults and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40549127/

Two-Year Efficacy and Safety of Lebrikizumab in Patients ... This analysis evaluates safety and maintenance of response through 104 weeks of lebrikizumab treatment in patients with moderate-to-severe AD.

5. ebglyss.lilly.com ebglyss.lilly.com/hcp/clinical-data

Clinical Data | EBGLYSS® (lebrikizumab-lbkz) - Eli Lilly Efficacy and safety of lebrikizumab is maintained up to 3 years in patients with moderate-to-severe atopic dermatitis: ADvocate 1 and ADvocate 2 to ADjoin long- ...

6. ebglyss.lilly.com ebglyss.lilly.com/

EBGLYSS® (lebrikizumab-lbkz): Treatment for Moderate-to ... Learn more about EBGLYSS® (lebrikizumab-lbkz), a moderate-to-severe eczema treatment for adults and children aged 12 and older who weigh at least 88 pounds.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/761306s003lbl.pdf

EBGLYSS (lebrikizumab-lbkz), injection, for subcutaneous use The safety and effectiveness of EBGLYSS have not been established in pediatric patients younger than 12 years of age and pediatric patients 12 years and older ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05559359

A Study of Lebrikizumab (LY3650150) in Participants 6 ... The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years ...

9. prnewswire.com prnewswire.com/news-releases/lillys-ebglyss-lebrikizumab-lbkz-delivered-durable-disease-control-when-administered-once-every-eight-weeks-in-patients-with-moderate-to-severe-atopic-dermatitis-302593427.html

Lilly's EBGLYSS (lebrikizumab-lbkz) delivered durable ... New long-term extension data show approximately 80% of patients achieved or maintained meaningful skin improvement (EASI 75) with EBGLYSS ...