Lebrikizumab for Eczema

(ADtouch Trial)

Recruiting at 84 trial locations

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

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Topical medications, IL-13 inhibitors

Disqualifiers: Allergic contact dermatitis, Protein contact dermatitis, 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

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

206 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop using topical medications (except for your own moisturizers) at least 2 weeks before starting the study. The protocol does not specify about other medications, so it's best to discuss with the study 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 (atopic dermatitis). Studies found that it improved skin condition and reduced itching, with most patients experiencing no significant side effects. ^{1 2 3 4 5}

How does the drug lebrikizumab differ from other treatments for eczema?

Lebrikizumab is unique because it is a monoclonal antibody that specifically targets interleukin-13 (IL-13), a protein involved in the inflammation process of eczema. This targeted approach helps reduce symptoms like itching and skin lesions, and it has shown rapid improvement in symptoms with a favorable safety profile compared to other treatments. ^{1 3 4 6 7}

What is the purpose of this trial?

The main purpose of this study is to assess the efficacy of lebrikizumab versus placebo on skin lesions in adults and adolescent participants with atopic hand and foot dermatitis. This study lasts up to 32 weeks, including a 6-week screening period, a 16-week treatment period, and a safety follow-up visit 12 weeks after the last dose.

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 adults and teens with chronic atopic hand or foot dermatitis lasting over a year, who haven't responded well to steroid creams. Participants must have moderate-to-severe symptoms in at least two of their hands or feet and experience significant itching.

Inclusion Criteria

* Have a baseline hand and foot peak pruritus (numeric rating scale) NRS score ≥4.

My hand-foot skin reaction is severe or very severe.

I weigh at least 40 kg.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment

Participants receive lebrikizumab or placebo for 16 weeks to assess efficacy on skin lesions

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 safety follow-up visit

Treatment Details

Interventions

• Lebrikizumab

Trial Overview The study tests Lebrikizumab's effectiveness against a placebo in improving skin lesions caused by severe eczema on the hands and feet. It includes a screening phase, treatment for 16 weeks, and follows up after 12 weeks post-treatment.

Participant Groups

Group I: Lebrikizumab Experimental Treatment 1 Intervention

Lebrikizumab administered subcutaneously (SC).

Group II: Placebo Placebo Group 1 Intervention

Placebo Administered SC.

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 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 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 interleukin 13 monoclonal antibody inhibitor, shows promising efficacy in treating atopic dermatitis, with rapid improvement in itching observed as early as 2 days after treatment.

The treatment is well tolerated and has an acceptable safety profile, with lower reported risks of infection compared to another treatment, dupilumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Atopic Dermatitis with Lebrikizumab - The Evidence to Date. Labib, A., Ju, T., Yosipovitch, G.[2022]

References

1. 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]

2. 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]

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

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

4. 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]

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

Therapeutic Potential of Lebrikizumab in the Treatment of Atopic Dermatitis. [2022]

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

Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: An Integrated Analysis of Eight Clinical Trials. [2023]

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

Managing Atopic Dermatitis with Lebrikizumab - The Evidence to Date. [2022]