RECRUITING

A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden

Description

The purpose of this study is to measure how well taking lebrikizumab alone works for participants with fewer places on the body with eczema (atopic dermatitis), but these places may be very itchy. Participation in this study will last up to approximately 38 weeks (9 and a half months) including 24 weeks (6 months) of treatment.

Study Overview

Study Details

Study overview

The purpose of this study is to measure how well taking lebrikizumab alone works for participants with fewer places on the body with eczema (atopic dermatitis), but these places may be very itchy. Participation in this study will last up to approximately 38 weeks (9 and a half months) including 24 weeks (6 months) of treatment.

A Phase 4, Multicenter, Open-label, Single-arm Study to Investigate the Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate Atopic Dermatitis and High Itch Burden

A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology, Birmingham, Alabama, United States, 35203

Litchfield Park

Research Solutions of Arizona, Litchfield Park, Arizona, United States, 85340

Phoenix

Alliance Dermatology and Mohs Center, Phoenix, Arizona, United States, 85032

Encinitas

California Dermatology & Clinical Research Institute, Encinitas, California, United States, 92024

Fountain Valley

First OC Dermatology Research Inc, Fountain Valley, California, United States, 92708

Los Angeles

Dermatology Research Associates, Los Angeles, California, United States, 90045

Rocklin

NorCal Clinical Research, Rocklin, California, United States, 95765

Doral

Suncoast Research Associates, Doral, Florida, United States, 33172

Hollywood

Encore Medical Research, Hollywood, Florida, United States, 33024

Jacksonville

Solutions Through Advanced Research, Jacksonville, Florida, United States, 32256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have chronic atopic dermatitis (AD) (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening visit.
  • * Have 10% to 25% body surface area (BSA) of AD involvement at screening and baseline.
  • * Have pruritus numeric rating scale (NRS) ≥6 at baseline.
  • * Have an Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.
  • * Have an Investigator's Global Assessment (IGA) score ≥3 (on a scale of 0 to 4) at screening and baseline.
  • * Based on investigator judgement, have a history of inadequate response to treatment with topical medications, or determination that topical treatments are otherwise medically inadvisable.
  • * For participants aged 12 to less than 18, have a body weight ≥40 kilograms (kg) at baseline.
  • * Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening (as defined by the investigator).
  • * Have known liver cirrhosis and/or chronic hepatitis of any etiology.
  • * History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
  • * Are diagnosed with active endoparasitic infections or at high risk of these infections.
  • * Have a known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per the investigator's judgment.
  • * Have presence of skin comorbidities that may interfere with study assessments.
  • * Have a severe concomitant illness(es) that in the investigator's judgment would adversely affect the participant's participation in the study.
  • * Have had any of the following types of infection within 3 months of screening or develop any of these infections during screening:
  • * Serious (requiring hospitalization, and/or intravenous or equivalent oral antibiotic treatment).
  • * Opportunistic - Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over.
  • * Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer).
  • * Recurring (including, but not limited to, recurring cellulitis and chronic osteomyelitis).
  • * Have an active or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit or superficial skin infections within 1 week before the baseline visit.
  • * Have had any prior treatment with a biologic therapy for AD.
  • * Have had treatment with any of the following agents within 4 weeks prior to the baseline visit:
  • * systemic immunosuppressive or immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon-gamma,
  • * azathioprine, methotrexate, and other immunosuppressants)
  • * small molecules (for example, Janus kinase inhibitors \[topical or systemic\]), or
  • * phototherapy and photochemotherapy for AD.
  • * Treatment with B-cell-depleting biologics, including rituximab, within 6 months prior to baseline.

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-09