Lebrikizumab for Eczema

(ADorable-1 Trial)

Recruiting at 118 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

Trial Summary

What is the purpose of this trial?

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 of age with moderate-to-severe atopic dermatitis (AD).

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.

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. In clinical trials, many patients experienced significant improvements in their skin condition and itchiness, with a good safety profile. ^{1 2 3 4 5}

Is lebrikizumab safe for treating eczema?

Lebrikizumab has been shown to be generally safe in clinical trials for moderate-to-severe eczema, with most patients experiencing no significant side effects. Common mild side effects included conjunctivitis (eye inflammation), nasopharyngitis (cold-like symptoms), and headache. ^{1 2 3 4 5}

What makes the drug Lebrikizumab unique for treating eczema?

Lebrikizumab is unique because it is a monoclonal antibody that specifically targets interleukin-13 (IL-13), a protein involved in the inflammation and skin barrier dysfunction seen in eczema. This targeted approach helps reduce symptoms like itching and skin lesions, offering a promising option for those with moderate-to-severe atopic dermatitis. ^{1 2 3 4 5}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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, 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]

References

1. Switzerland 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The role of lebrikizumab in the treatment of atopic dermatitis in the adult population. [2023]

3. United States 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). [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Lebrikizumab for the Treatment of Moderate-to-Severe Atopic Dermatitis. [2023]

5. Switzerland 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. [2023]