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

Trial Summary

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 data supports the effectiveness of the drug Lebrikizumab for treating atopic dermatitis?

Research shows that Lebrikizumab, which targets a protein called interleukin-13 involved in skin inflammation, has been effective in improving symptoms of moderate-to-severe atopic dermatitis in several clinical trials. Patients experienced significant improvements in skin condition and itchiness, with most not having serious side effects. ^{1 2 3 4 5}

Is lebrikizumab safe for humans?

Lebrikizumab has been shown to have a favorable safety profile in clinical trials for moderate-to-severe atopic dermatitis, with most patients experiencing no significant adverse events. ^{1 2 3 4 5}

What makes the drug Lebrikizumab unique for treating atopic dermatitis?

Lebrikizumab is unique because it specifically targets interleukin-13 (IL-13), a key player in the inflammation and skin barrier issues seen in atopic dermatitis. This targeted approach can lead to better control of symptoms with fewer side effects compared to traditional treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

This research is studying a drug already approved for the treatment of atopic dermatitis (AD). This research collects health-related information and blood and skin samples to understand if the study drug, lebrikizumab, leads to long-term improvement in AD skin.

Research Team

Johann E. Gudjonsson, MD, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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, 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]

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. 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]

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

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

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

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