Lebrikizumab for Atopic Dermatitis

(ADorable-2 Trial)

Recruiting at 116 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Pregnancy, Breastfeeding, Serious adverse events, 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: 29

Duration: 68 weeks

310 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \<18 years of age with moderate-to-severe atopic dermatitis. This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions a 'washout period' for systemic AD treatments from a previous study. It's best to discuss your specific medications with the study team.

Is lebrikizumab safe for treating atopic dermatitis?

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

What makes the drug lebrikizumab unique for treating atopic dermatitis?

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 atopic dermatitis. This targeted approach helps reduce symptoms like itching and skin lesions, offering a promising option for patients with moderate-to-severe atopic dermatitis who have limited treatment choices. ^{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 children and teenagers aged 6 months to less than 18 years with moderate-to-severe atopic dermatitis. Participants must have completed a previous study (KGBI) without serious side effects related to the treatment, not be pregnant or breastfeeding, and agree to use effective contraception if applicable.

Inclusion Criteria

For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI.

Exclusion Criteria

I was removed or withdrew from study KGBI due to issues related to lebrikizumab or other reasons like noncompliance.

You had a bad reaction to lebrikizumab during a previous study, and the doctors think it's not safe for you to take it again.

If my previous study's results are unknown, any side effects are assumed to be from lebrikizumab.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lebrikizumab administered subcutaneously for moderate-to-severe atopic dermatitis

68 weeks

16 planned visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Extension

Participants may opt into an additional year of treatment to assess long-term safety and efficacy

1 year

13 additional visits

Treatment Details

Interventions

• Lebrikizumab
• Placebo

Trial Overview The trial is testing the long-term safety and effectiveness of Lebrikizumab compared to a placebo in young patients with atopic dermatitis. It aims to see how well Lebrikizumab works over an extended period and monitor any ongoing risks or benefits.

Participant Groups

Group I: Lebrikizumab - Optional Extension Period (OEP) Experimental Treatment 1 Intervention

During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52.

Group II: Lebrikizumab Experimental Treatment 2 Interventions

Participants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.

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

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 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]

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 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]

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. 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]

3. 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]

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

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

5. England pubmed.ncbi.nlm.nih.gov

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