Lebrikizumab for Eczema

(ADorable-1 Trial)

Recruiting at 130 trial locations

Overseen By Seth Benjamin Forman

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Dupilumab

Disqualifiers: Recent clinical study, others

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: 12 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of lebrikizumab, an experimental drug, for children with eczema, also known as atopic dermatitis. It focuses on children aged 6 months to under 18 years with moderate to severe eczema. The trial will assess the effectiveness and safety of lebrikizumab, as well as how the body absorbs it. Children with long-standing eczema that significantly affects their skin may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for eczema.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have used certain investigational drugs or Dupilumab recently. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lebrikizumab is generally safe and effective for treating moderate-to-severe eczema. It is effective and safe for adults and children aged 12 and older who weigh at least 88 pounds. For younger children, newer studies also support its safety. Over two years, participants using lebrikizumab reported mostly mild side effects, such as headaches or reactions at the injection site. Serious side effects were rare. Overall, evidence suggests that lebrikizumab is a safe option for managing eczema symptoms in both adults and children. ^{1 2 3 4 5}

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

Lebrikizumab is unique because it targets interleukin-13 (IL-13), a key player in the inflammatory process of eczema. Most treatments for eczema, like topical corticosteroids and calcineurin inhibitors, address symptoms on the skin surface. But lebrikizumab works from within by specifically blocking IL-13, potentially reducing inflammation more effectively. This targeted approach could lead to better control of eczema symptoms and improve the quality of life for patients, especially those who haven't had success with current options. Researchers are excited because this could mean a new era of precision treatment for eczema.

What evidence suggests that this trial's treatments could be effective for atopic dermatitis?

Studies have shown that lebrikizumab effectively treats moderate-to-severe atopic dermatitis, a type of eczema. In earlier trials, about 80% of patients experienced significant symptom improvement, achieving EASI 75, which indicates a 75% reduction in eczema severity. Research has also found that these improvements last long-term, with benefits continuing for up to three years. Lebrikizumab targets specific proteins in the immune system that cause skin inflammation, effectively reducing eczema symptoms. Participants in this trial may receive lebrikizumab or a placebo, both administered with a topical corticosteroid. ^{4 5 6 7 8}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 kids aged 6 months to less than 18 years with moderate-to-severe atopic dermatitis (eczema). They must have had eczema for a certain time and meet specific severity scores. Kids can't join if they've used experimental skin treatments recently, been in another study, or received certain vaccines or drugs too close to the start of this trial.

Inclusion Criteria

Your IGA score is 3 or higher during the screening and baseline.

You have a skin condition with an EASI score of 16 or higher at the screening and baseline.

I have been diagnosed with atopic dermatitis for the required time based on my age.

Exclusion Criteria

I have not taken Dupilumab in the last 8 weeks.

I received a BCG vaccine or treatment less than 4 weeks ago.

I haven't taken any experimental drugs recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lebrikizumab or placebo by subcutaneous injections with a topical corticosteroid, dosing based on weight

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lebrikizumab
• Placebo
• Topical corticosteroid

Trial Overview The study tests Lebrikizumab's effects on young patients with eczema compared to a placebo, alongside standard eczema creams. It aims to see how safe it is and how their bodies handle it.

How Is the Trial Designed?

Group I: Lebrikizumab (Cohort 2) Experimental Treatment 2 Interventions

Participants who are 6 months to \<6 years of age, 2 years to \<6 years of age or 6 months to \<2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS. Dosing will be based on weight.

Group II: Lebrikizumab (Cohort 1) Experimental Treatment 2 Interventions

Participants who are 6 years to \<18 years of age, 12 years to \<18 years of age who weigh \<40 kilogram (kg) or 6 years to \<12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS). Dosing will be based on weight.

Group III: Placebo Placebo Group 2 Interventions

Participants will receive placebo matching lebrikizumab by SC injections with a TCS.

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

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 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, 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 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 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]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36994947/

Efficacy and safety of lebrikizumab in moderate-to-severe ... Response at week 16 was defined as achieving a 75% reduction in Eczema Area Severity Index (EASI 75) or an Investigator's Global Assessment (IGA) ...

3. 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.

4. 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 ...

5. 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 ...

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/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.