RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-06-16

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07006792

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.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

CONTACT

3176154559

clinical_inquiry_hub@lilly.com

Principal Investigator

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 Locations (Sites)

Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology

Birmingham, Alabama, 35203

United States

Research Solutions of Arizona

Litchfield Park, Arizona, 85340

United States

Alliance Dermatology and Mohs Center

Phoenix, Arizona, 85032

United States

California Dermatology & Clinical Research Institute

Encinitas, California, 92024

United States

First OC Dermatology Research Inc

Fountain Valley, California, 92708

United States

Dermatology Research Associates

Los Angeles, California, 90045

United States

NorCal Clinical Research

Rocklin, California, 95765

United States

Suncoast Research Associates

Doral, Florida, 33172

United States

Encore Medical Research

Hollywood, Florida, 33024

United States

Solutions Through Advanced Research

Jacksonville, Florida, 32256

United States

Deluxe Health Center

Miami Lakes, Florida, 33014

United States

Life Arc Research Centers - Miami

Miami, Florida, 33126

United States

MCR Research

Miami, Florida, 33126

United States

Health Clinical Research

Miami, Florida, 33176

United States

Renstar Medical Research

Ocala, Florida, 34470

United States

Leading Edge Dermatology

Plantation, Florida, 33317

United States

Research Institute of the Southeast

West Palm Beach, Florida, 33401

United States

Dermatology Affiliates Research Institute

Atlanta, Georgia, 30305

United States

Revival Research Institute, LLC

Evans, Georgia, 30809

United States

DeNova Research

Chicago, Illinois, 60602

United States

Southern Indiana Clinical Research Center

Columbus, Indiana, 47201

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

United States

Southern Indiana Clinical Trials

New Albany, Indiana, 47150

United States

Equity Medical - Bowling Green

Bowling Green, Kentucky, 42104

United States

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky, 42301

United States

Foxhall Research Center

Chevy Chase, Maryland, 20815

United States

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706

United States

Revival Research Institute, LLC

Troy, Michigan, 48084

United States

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102

United States

Equity Medical

New York, New York, 10023

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Hickory Dermatology Research Center

Hickory, North Carolina, 28602

United States

Wright State Physicians

Fairborn, Ohio, 45324

United States

ObjectiveHealth - Goodlettsville Dermatology Research

Goodlettsville, Tennessee, 37072

United States

John Peter Smith Hospital

Fort Worth, Texas, 76104

United States

Reveal Research Institute - Frisco

Frisco, Texas, 75033

United States

Biopharma Informatic, LLC

Houston, Texas, 77084

United States

Prime Clinical Research - Mansfield

Mansfield, Texas, 76063

United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218

United States

Jordan Valley Dermatology & Research Center

South Jordan, Utah, 84095

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-16

Study Completion Date2026-09

Study Record Updates

Study Start Date2025-06-16

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Atopic Dermatitis