Lebrikizumab for Eczema

(ADjoin Trial)

Not currently recruiting at 421 trial locations

Overseen By Howard Sofen

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Immunosuppressives, Biologics, Corticosteroids, others

Disqualifiers: Pregnancy, Anaphylaxis, HIV, 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: 33 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety and effectiveness of lebrikizumab, a treatment for individuals with moderate-to-severe eczema (also known as atopic dermatitis). Participants will receive lebrikizumab injections at intervals of every 2, 4, or 8 weeks. Ideal candidates have experienced eczema for at least a year and have found little relief from topical treatments. The study aims to determine if lebrikizumab can provide lasting improvement in eczema symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications before starting, such as topical prescription moisturizers, corticosteroids, and some immunosuppressive drugs. There is a specific period you must wait after stopping these medications before you can begin 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. In studies lasting up to two years, patients tolerated lebrikizumab well. Most side effects were mild, such as headaches and cold symptoms, and serious side effects were rare.

Lebrikizumab is approved for treating eczema in individuals over 12 who weigh at least 40 kg (about 88 pounds). This approval indicates that the treatment has passed strict safety tests. Safety data from these studies support its use and demonstrate that it reduces eczema symptoms while being well-tolerated over long periods. ^{1 2 3 4 5}

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

Lebrikizumab is unique because it targets the IL-13 protein, a key player in the inflammation that causes eczema. Current treatments like topical steroids and calcineurin inhibitors often address symptoms rather than the root cause. Lebrikizumab offers a targeted approach by blocking IL-13, potentially reducing inflammation more effectively and with fewer side effects. Researchers are excited about this treatment because it could offer longer-lasting relief with less frequent dosing, improving the quality of life for people with eczema.

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

Research has shown that lebrikizumab effectively treats moderate-to-severe eczema. Studies have found that lebrikizumab helps clear the skin and reduce itching for many patients. In two separate studies, 16 weeks of treatment led to significant improvements in skin condition for both teenagers and adults. Additionally, some patients experienced benefits for up to three years, indicating long-term effectiveness. This treatment works by blocking a protein that causes inflammation, a key factor in eczema. Participants in this trial may receive lebrikizumab at different dosing intervals, such as once every 2 weeks (Q2W), once every 4 weeks (Q4W), or once every 8 weeks (Q8W), to evaluate its effectiveness and safety. ^{5 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?

Adults and adolescents (12+ years, ≥40 kg) with chronic moderate-to-severe atopic dermatitis for over a year, who haven't responded well to topical treatments. Participants must not be pregnant or breastfeeding, agree to contraception if applicable, and have no recent live vaccines or use of certain drugs. Excludes those with serious reactions to lebrikizumab in past trials.

Inclusion Criteria

Participants coming from a parent study must have received treatment in a lebrikizumab study and have adequately completed the study treatments and last patient visit of the parent trial

I agree to use birth control or abstain from sex during and for 18 weeks after my treatment.

Participants for the Open-Label Extension Addendum must have completed Week 100 of Study KGAA and have not yet completed the safety follow-up visit for the main study

Exclusion Criteria

I don't have hepatitis, HIV, cancer in the last 5 years, or certain medical conditions.

I have never taken lebrikizumab or had a severe allergic reaction.

I have not used certain immune drugs, had phototherapy, or received live vaccines recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lebrikizumab treatment every 2, 4, or 8 weeks by subcutaneous injection

33 months

Open-label extension

Participants may continue receiving lebrikizumab treatment every 2, 4, or 8 weeks by subcutaneous injection

32 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 long-term safety and effectiveness of Lebrikizumab in treating moderate-to-severe atopic dermatitis over a period of 110 weeks. It aims to see how well it works over time and what side effects may occur with extended use.

How Is the Trial Designed?

Group I: Lebrikizumab Q8W (Open-Label Extension Addendum) Experimental Treatment 1 Intervention

Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q8W by SC injection.

Group II: Lebrikizumab Q4W (Open-Label Extension Addendum) Experimental Treatment 1 Intervention

Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q4W by SC injection.

Group III: Lebrikizumab Q4W Experimental Treatment 1 Intervention

Participants assigned to lebrikizumab Q4W (once every 4 weeks) arm will receive investigational product Q4W by SC injection. Intervention assigned: Lebrikizumab balanced with Placebo to maintain the blind between treatment arms.

Group IV: Lebrikizumab Q2W (Open-Label) from Parent Study Experimental Treatment 1 Intervention

Participants assigned to lebrikizumab Q2W (once every 2 weeks) arm will receive investigational product Q2W by subcutaneous (SC) injection.

Group V: Lebrikizumab Q2W (Open-Label Extension Addendum) Experimental Treatment 1 Intervention

Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q2W by SC injection.

Group VI: Lebrikizumab Q2W (Open-Label Addendum) Experimental Treatment 1 Intervention

Participants enrolling in Open-Label Addendum will receive lebrikizumab Q2W by SC injection after loading doses.

Group VII: Lebrikizumab Q2W (Blinded) from Parent Study Experimental Treatment 1 Intervention

Participants assigned to lebrikizumab Q2W arm will receive investigational product Q2W by SC injection. Some participants will receive loading doses.

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

Dermira, Inc.

Industry Sponsor

Trials

17

Recruited

6,100+

Published Research Related to This Trial

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]

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]

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]

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. 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.

2. 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- ...

3. 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 ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/lillys-ebglyss-clearance-dermatitis-trial/

Eli Lilly's Ebglyss shows sustained skin clearance in atopic ... Eli Lilly has reported that its IL-13 inhibitor Ebglyss showed sustained skin clearance for moderate-to-severe atopic dermatitis in the ...

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

Two Phase 3 Trials of Lebrikizumab for Moderate-to- ... In the induction period of two phase 3 trials, 16 weeks of treatment with lebrikizumab was effective in adolescents and adults with moderate-to-severe atopic ...

6. pi.lilly.com pi.lilly.com/us/ebglyss-uspi.pdf

ebglyss-uspi.pdf The safety and effectiveness of EBGLYSS have been established in pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/761306s000lbledt.pdf

EBGLYSS (lebrikizumab-lbkz), injection, for subcutaneous use The safety and effectiveness of EBGLYSS have been established in pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe ...

8. 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.

9. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/ebglyss

Ebglyss | European Medicines Agency (EMA) Ebglyss has been shown to reduce the extent and severity of atopic dermatitis in people with moderate to severe atopic dermatitis, for whom available therapies ...