Lebrikizumab for Eczema

(ADapt Trial)

No longer recruiting at 81 trial locations

Overseen By Matthew James Zirwas

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must be taking: Dupilumab

Must not be taking: 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 effectiveness and safety of lebrikizumab, a new treatment for people with moderate-to-severe eczema (atopic dermatitis) who have previously tried dupilumab. The researchers aim to determine how well lebrikizumab works and if it's safe for those who didn't find enough relief from dupilumab or experienced issues with it. People who have had eczema for at least a year and have not responded well to topical treatments might be suitable candidates. The trial involves injections of lebrikizumab. 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 not have used Dupilumab within 4 weeks before the trial, and you should not have used certain topical treatments or systemic drugs like corticosteroids within 2 to 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 people with moderate-to-severe eczema. Most side effects are mild to moderate, such as reactions at the injection site, which are common with injections. Serious side effects are rare.

One study examined lebrikizumab's safety over two years and confirmed it remained safe for long-term use. This finding reassures those considering joining the trial. The treatment's approval for similar conditions further supports its safety. ^{1 2 3 4 5}

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

Unlike the standard treatments for eczema, which often include topical steroids or calcineurin inhibitors, lebrikizumab is unique because it targets a specific protein involved in the inflammatory process. Lebrikizumab is a monoclonal antibody that blocks interleukin-13 (IL-13), a key cytokine that plays a significant role in the skin inflammation associated with eczema. This targeted approach not only directly addresses the underlying cause of inflammation but also offers a novel method of administration through subcutaneous injection, which might be more convenient for some patients compared to daily topical applications. Researchers are excited about lebrikizumab's potential to provide more effective relief with potentially fewer side effects than current options.

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

Research has shown that lebrikizumab can help treat moderate-to-severe atopic dermatitis, also known as eczema. In one study, patients experienced significant improvements in their skin and had less itching. Two trials, ADvocate 1 and ADvocate 2, found that lebrikizumab helped maintain these improvements over time. Another study confirmed its effectiveness and safety, even for people with different skin tones. These findings suggest that lebrikizumab could be a promising option for those with moderate-to-severe eczema. Participants in this trial will receive lebrikizumab by subcutaneous injection to further evaluate its effectiveness and safety. ^{1 4 5 6 7}

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?

Adults and adolescents with moderate-to-severe atopic dermatitis (AD) who previously used Dupilumab but stopped due to intolerance, adverse events, cost issues, or lack of efficacy. They must have had AD for over a year, an IGA score of ≥3, EASI score ≥16, and at least 10% body surface area affected. Adolescents must weigh ≥40 kg. Exclusions include HIV infection, uncontrolled asthma requiring steroids recently, liver disease like cirrhosis/hepatitis, recent use of certain AD treatments including Dupilumab.

Inclusion Criteria

I stopped using dupilumab after 4 months due to it not working well enough.

I stopped taking dupilumab because it caused side effects or I couldn't tolerate it.

I have been treated with dupilumab under certain conditions.

Exclusion Criteria

You currently have a hepatitis C virus (HCV) infection.

I frequently need oral steroids for a chronic condition.

My asthma has been severe, needing steroids or hospital stays in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lebrikizumab by subcutaneous injection for the treatment of moderate-to-severe atopic dermatitis

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 trial is testing the safety and effectiveness of Lebrikizumab in those who've had previous treatment with Dupilumab without success or could not tolerate it. The goal is to see if Lebrikizumab can improve symptoms in patients with moderate-to-severe AD.

How Is the Trial Designed?

Group I: Lebrikizumab Experimental Treatment 1 Intervention

Participants will receive Lebrikizumab by subcutaneous (SC) injection.

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

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 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 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, 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]

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]

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]

Citations

1. 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- ...

2. 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.

3. 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.

4. 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 ...

5. 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.

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. 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 ...