Lebrikizumab for Eczema

(ADsolve Trial)

Recruiting at 75 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Eli Lilly and Company

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

Disqualifiers: Chronic disease, Liver cirrhosis, Malignancy, 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: 24 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests lebrikizumab, a treatment for eczema, to evaluate its effectiveness when used alone. The goal is to determine if it can reduce eczema patches, particularly those that are very itchy. Individuals with eczema for at least a year, who find ointments or creams ineffective, might be suitable for this study. Participants will receive the treatment for about six months and will be involved in the trial for approximately nine and a half months. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting, such as systemic immunosuppressive drugs and biologic therapies for eczema. If you're on these, you'll need to stop them at least 4 weeks before the trial begins.

What is the safety track record for this treatment?

Research has shown that lebrikizumab is generally safe for people with moderate-to-severe eczema (also known as atopic dermatitis). Earlier studies demonstrated a good safety record for lebrikizumab, with no new or unexpected side effects found in adults and teenagers.

Lebrikizumab is already approved in the U.S. for treating moderate-to-severe eczema, indicating its safety for other patients with this condition.

Overall, current evidence supports the safety of lebrikizumab for those considering participation in this clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Lebrikizumab is unique because it targets eczema differently than current options. Most treatments for eczema, like topical steroids or calcineurin inhibitors, focus on reducing inflammation at the skin's surface. Lebrikizumab, on the other hand, is a monoclonal antibody that works by blocking the activity of interleukin-13 (IL-13), a key protein involved in the inflammatory pathway that causes eczema. This targeted approach may offer more precise control of the condition with potentially fewer side effects. Researchers are excited about the possibility of improved effectiveness and safety compared to traditional therapies.

What is the effectiveness track record for lebrikizumab in treating eczema?

Research has shown that lebrikizumab, the investigational treatment in this trial, effectively treats moderate-to-severe eczema, also known as atopic dermatitis. In two studies, after 16 weeks, about 68.4% of patients experienced significant improvement in their skin condition, compared to 40.8% who did not receive the treatment. Another study found that lebrikizumab consistently reduced eczema symptoms over 36 weeks. The treatment is considered safe and has improved the quality of life for people with eczema. Lebrikizumab works similarly well to other treatments like dupilumab, making it a strong option for managing eczema. ^{2 3 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 adolescents with moderate atopic dermatitis (eczema) who experience a high level of itchiness. Participants should have fewer affected areas, but these should be significantly itchy. The study will last about 9 and a half months, including 6 months of treatment.

Inclusion Criteria

Have an Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline

Have an Investigator's Global Assessment (IGA) score ≥3 at screening and baseline

I rate my itchiness at 6 or more out of 10.

Exclusion Criteria

I frequently need oral steroids for a chronic condition.

I have liver cirrhosis or chronic hepatitis.

I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that were fully treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lebrikizumab subcutaneously for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lebrikizumab

Trial Overview

The trial is testing the effectiveness of Lebrikizumab in reducing itchiness and improving eczema symptoms over a period of approximately 38 weeks. It aims to see how well participants respond to taking Lebrikizumab alone.

How Is the Trial Designed?

Group I: Lebrikizumab Experimental Treatment 1 Intervention

Lebrikizumab administered subcutaneously (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

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36994947/

Efficacy and safety of lebrikizumab in moderate-to-severe ...

Objectives: To evaluate the efficacy and safety of lebrikizumab monotherapy in adolescent and adult patients with moderate-to-severe atopic ...

7.

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.

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 ...