Lebrikizumab for Atopic Dermatitis

(ADfind Trial)

Recruiting at 3 trial locations

Overseen By Diane Fiolek

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Johann E Gudjonsson MD PhD

Must not be taking: Immunosuppressants, Biologics, Corticosteroids, others

Disqualifiers: HIV, Hepatitis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 60 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether lebrikizumab, an antibody treatment, can provide long-term relief for people with atopic dermatitis (AD), a skin condition that causes itchy and inflamed skin. Researchers will collect health data and skin samples to assess how the drug improves the skin over time. The trial seeks participants who have had moderate-to-severe AD for at least a year, affecting more than 10% of their body, and for whom topical treatments have not been effective. As a Phase 4 trial, this research aims to understand how this already FDA-approved and proven effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before participating. You must stop using topical corticosteroids, calcineurin inhibitors, Jak inhibitors, or crisaborole at least 1 week before the baseline visit, and other immunosuppressive drugs 4 weeks prior. Prescription moisturizers should not be used within 7 days of the baseline visit.

What is the safety track record for lebrikizumab?

Research has shown that lebrikizumab is generally well-tolerated by people with moderate-to-severe atopic dermatitis (AD). Previous studies found the drug to be safe, with no new safety issues reported in adults and teenagers using it.

In one study, only 0.4% of patients developed nonmelanoma skin cancer, compared to 1.4% in those who took a placebo, suggesting that serious side effects are rare. Another study confirmed that lebrikizumab is safe for long-term use, even over two years of treatment.

Overall, based on past research, lebrikizumab appears to be a safe option for treating AD. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Lebrikizumab is unique because it targets a specific protein called IL-13, which plays a key role in the inflammation associated with atopic dermatitis. Unlike traditional treatments like corticosteroids or calcineurin inhibitors that broadly suppress the immune system, lebrikizumab offers a more targeted approach, potentially reducing side effects. Researchers are excited about this treatment because its precision could lead to more effective management of moderate-to-severe atopic dermatitis with fewer unwanted effects, improving quality of life for patients.

What is the effectiveness track record for lebrikizumab in treating atopic dermatitis?

Studies have shown that lebrikizumab effectively treats moderate-to-severe atopic dermatitis (AD), a type of eczema. In earlier research, 68.4% of patients using lebrikizumab experienced significant improvement in their skin condition, compared to only 40.8% of those who received a placebo, which contains no active medicine. The treatment proved safe and provided lasting benefits. It has been particularly effective across different groups, enhancing their quality of life. This evidence supports its ability to manage symptoms and provide relief for those with this skin condition. ^{1 2 3 6 7}

Who Is on the Research Team?

Johann E. Gudjonsson, MD, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with moderate-to-severe atopic dermatitis, including eczema of the ear canal and vasculopathic skin disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could impact their safety or the study's results.

Inclusion Criteria

Subject willing and able to comply with all of the clinical study protocol's time commitments and procedural requirements

Understand and sign an informed consent form (ICF) before any investigational procedure(s) are performed

I have had AD for over a year and topical treatments haven't worked or aren't suitable.

Exclusion Criteria

Severe concomitant illness(es) that may adversely affect participation in the study

Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

History of human immunodeficiency virus (HIV) infection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lebrikizumab for the treatment of moderate-to-severe atopic dermatitis

60 weeks

Regular visits for assessments and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lebrikizumab

Trial Overview The study is examining lebrikizumab, a drug approved for treating atopic dermatitis. It aims to collect health data along with blood and skin samples from participants to evaluate long-term improvements in AD symptoms.

How Is the Trial Designed?

Group I: Moderate-to-severe Atopic Dermatitis Experimental Treatment 1 Intervention

A total of 48 subjects with active moderate-to-severe Atopic Dermatitis (AD) will be enrolled in a 60-week study from 4 independent sites (2 US sites and 2 EU sites).

Who Is Running the Clinical Trial?

Johann E Gudjonsson MD PhD

Lead Sponsor

Almirall, S.A.

Industry Sponsor

Trials

63

Recruited

19,200+

Carlos Gallardo Piqué

Almirall, S.A.

Chief Executive Officer since 2023

MS in Industrial Engineering from Universitat Politècnica de Catalunya, MBA from Stanford Graduate School of Business

Mercedes Diz

Almirall, S.A.

Chief Medical Officer since 2023

PhD in Biochemistry

Dermira, Inc.

Industry Sponsor

Trials

17

Recruited

6,100+

Published Research Related to This Trial

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]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40665146/

Results from the Phase IIIb, Open-Label ADmirable Study The aim of this study was to evaluate the efficacy and safety of lebrikizumab in adults and adolescents with skin of color and moderate-to-severe AD.

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962224034145

The efficacy of longer-term lebrikizumab treatment in ... Lebrikizumab demonstrated statistically significant improvements in patients with moderate-to-severe atopic dermatitis at week 16 with a durable response up to ...

6. 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.

7. 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.