Lebrikizumab for Eczema

(ADtouch Trial)

Recruiting at 110 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called lebrikizumab, an experimental drug, to determine its effectiveness for eczema on the hands and feet. Researchers aim to find out if lebrikizumab reduces skin problems more effectively than a placebo, which contains no active treatment. The trial seeks participants who have experienced chronic eczema on their hands and/or feet for at least a year and have not found relief with regular creams or ointments. Participants will receive either the experimental treatment or a placebo, and the study will last up to 32 weeks. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially bringing a new treatment to market.

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.

Is there any evidence suggesting that lebrikizumab is likely to be safe for humans?

Research has shown that lebrikizumab was well-tolerated in past studies involving both young and adult patients with moderate-to-severe atopic dermatitis, a type of eczema. Lebrikizumab demonstrated a good safety record, with most participants not experiencing serious side effects.

Lebrikizumab is approved in the U.S. for treating moderate-to-severe atopic dermatitis, indicating it meets certain safety standards. While some side effects, such as injection site reactions or headaches, might occur, these studies have not identified any new safety issues. This suggests that lebrikizumab is generally safe to use based on current evidence. ^{1 2 3 4 5}

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

Lebrikizumab is unique because it specifically targets a protein called IL-13, which plays a crucial role in causing inflammation in eczema. Unlike traditional treatments like corticosteroids or topical calcineurin inhibitors, which broadly suppress the immune system, lebrikizumab offers a more targeted approach, potentially reducing side effects. Researchers are excited about its potential to provide significant relief with a more precise mechanism of action, which could mean better outcomes for patients with eczema.

What evidence suggests that lebrikizumab might be an effective treatment for eczema?

Research has shown that lebrikizumab, which participants in this trial may receive, effectively treats atopic dermatitis, a type of eczema. One study found that after 16 weeks, 68.4% of people using lebrikizumab experienced significant skin improvement, compared to 40.8% of those who took a placebo. Lebrikizumab proved effective on all body areas and improved various symptoms over 36 weeks. It is considered safe and works similarly to another treatment called dupilumab. These findings suggest that lebrikizumab could be a promising option for people with eczema. ^{2 4 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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

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]

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, 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40711950/

Thirty-Six-Week Real-World Effectiveness of Lebrikizumab ... Results: Lebrikizumab consistently decreased EASI on all anatomical sites and all clinical signs through 36 weeks. Week 36 achievement rates of ...

2. 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 ...

3. academic.oup.com academic.oup.com/bjd/article/193/5/876/8262125

Efficacy and safety of lebrikizumab in adult and adolescent ... At week 16, a significantly higher proportion of the lebrikizumab group vs. the placebo group achieved EASI 75 (68.4% vs. 40.8%; P < 0.001). At ...

4. link.springer.com link.springer.com/article/10.1007/s13555-025-01550-8

Effectiveness, Safety, and Health-Related Quality of Life in ... Overall, this study shows that lebrikizumab is safe and effective for the treatment of moderate-to-severe atopic dermatitis in white patients.

5. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2821284

Systemic Immunomodulatory Treatments for Atopic Dermatitis These findings indicate that lebrikizumab, a new biologic medication, has comparable efficacy to dupilumab for the treatment of atopic dermatitis in adults.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12436573/

Efficacy and Safety of Lebrikizumab in Adult and Adolescent ... Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: 52-week results of two randomized double-blinded placebo ...

7. jaad.org jaad.org/article/S0190-9622(24)02264-3/fulltext

52041 Safety of lebrikizumab in adults and adolescents ... We provide updated lebrikizumab long-term safety in adults and adolescents with moderate-to-severe atopic dermatitis.

8. skin.dermsquared.com skin.dermsquared.com/skin/article/view/3385

Safety Profile of Lebrikizumab in Adults and Adolescents with ... Lebrikizumab was recently approved in the US for treatment of moderate-to-severe atopic dermatitis. Safety data have been reported from individual trial ...