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

NCT07006792 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 27407J2T-MC-KGCE
• Study Type: interventional
• Target: 200
• Locations: 5 countries
• Sites: 66

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% Reduction from Baseline in EASI), or a ≥4-point Reduction in Pruritus Numerical Rating Scale (NRS) from Baseline

  The primary endpoint will be a composite endpoint as defined by achieving either EASI-75 or Pruritus NRS≥4-point Reduction from Baseline.

  Week 16

Secondary Outcomes (11)

• Percentage of Participants Achieving EASI-75

  Baseline to Week 24

• Percentage of Participants Achieving a ≥4-point Reduction from Baseline in Pruritus NRS

  Baseline to Week 24

• Percentage of Participants with an Investigator's Global Assessment (IGA) of 0 or 1 and a Reduction ≥2 points from Baseline

  Baseline to Week 24

• Percentage of Participants Achieving EASI-90

  Baseline to Week 24

• Change from Baseline in Body Surface Area (BSA) Involvement

  Baseline, Week 24

Study Arms (1)

Lebrikizumab

EXPERIMENTAL

Lebrikizumab administered subcutaneously (SC).

Drug: Lebrikizumab

Interventions

Lebrikizumab DRUG

Administered SC

Also known as: LY3650150

Lebrikizumab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (66)

Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology

Birmingham, Alabama, 35203, United States

ACTIVE NOT RECRUITING

Research Solutions of Arizona

Litchfield Park, Arizona, 85340, United States

RECRUITING

Alliance Dermatology and Mohs Center

Phoenix, Arizona, 85032, United States

ACTIVE NOT RECRUITING

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

RECRUITING

Dermatology Research Associates

Los Angeles, California, 90045, United States

ACTIVE NOT RECRUITING

NorCal Clinical Research

Rocklin, California, 95765, United States

ACTIVE NOT RECRUITING

Suncoast Research Associates

Doral, Florida, 33172, United States

COMPLETED

Encore Medical Research

Hollywood, Florida, 33024, United States

ACTIVE NOT RECRUITING

Solutions Through Advanced Research

Jacksonville, Florida, 32256, United States

ACTIVE NOT RECRUITING

Life Arc Research Centers - Miami

Miami, Florida, 33126, United States

COMPLETED

MCR Research

Miami, Florida, 33126, United States

ACTIVE NOT RECRUITING

Health Clinical Research

Miami, Florida, 33176, United States

ACTIVE NOT RECRUITING

Deluxe Health Center

Miami Lakes, Florida, 33014, United States

ACTIVE NOT RECRUITING

Renstar Medical Research

Ocala, Florida, 34470, United States

COMPLETED

Leading Edge Dermatology

Plantation, Florida, 33317, United States

ACTIVE NOT RECRUITING

Dermatology Affiliates Research Institute

Atlanta, Georgia, 30305, United States

COMPLETED

DeNova Research

Chicago, Illinois, 60602, United States

ACTIVE NOT RECRUITING

Southern Indiana Clinical Research Center

Columbus, Indiana, 47201, United States

COMPLETED

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

ACTIVE NOT RECRUITING

Southern Indiana Clinical Trials

New Albany, Indiana, 47150, United States

ACTIVE NOT RECRUITING

Equity Medical - Bowling Green

Bowling Green, Kentucky, 42104, United States

ACTIVE NOT RECRUITING

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky, 42301, United States

COMPLETED

Foxhall Research Center

Chevy Chase, Maryland, 20815, United States

COMPLETED

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

RECRUITING

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

ACTIVE NOT RECRUITING

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

ACTIVE NOT RECRUITING

Equity Medical

New York, New York, 10023, United States

ACTIVE NOT RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

ACTIVE NOT RECRUITING

Hickory Dermatology Research Center

Hickory, North Carolina, 28602, United States

COMPLETED

ObjectiveHealth - Goodlettsville Dermatology Research

Goodlettsville, Tennessee, 37072, United States

COMPLETED

Reveal Research Institute - Frisco

Frisco, Texas, 75033, United States

ACTIVE NOT RECRUITING

Biopharma Informatic, LLC

Houston, Texas, 77084, United States

ACTIVE NOT RECRUITING

Prime Clinical Research - Mansfield

Mansfield, Texas, 76063, United States

ACTIVE NOT RECRUITING

Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue

San Antonio, Texas, 78235, United States

ACTIVE NOT RECRUITING

Jordan Valley Dermatology & Research Center

South Jordan, Utah, 84095, United States

ACTIVE NOT RECRUITING

CONEXA Investigacion Clinica S.A.

Buenos Aires, 1012, Argentina

ACTIVE NOT RECRUITING

CIPREC

Buenos Aires, 1061, Argentina

ACTIVE NOT RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI, Argentina

ACTIVE NOT RECRUITING

DOM Centro de Reumatología

Buenos Aires, C1111, Argentina

ACTIVE NOT RECRUITING

Instituto de Neumonologia Y Dermatologia

Buenos Aires, C1425BEA, Argentina

ACTIVE NOT RECRUITING

Psoriahue

Buenos Aires, C1425DKG, Argentina

ACTIVE NOT RECRUITING

Fundación Respirar

Buenos Aires, C1426ABP, Argentina

ACTIVE NOT RECRUITING

Parra Dermatología

Mendoza, 5500, Argentina

ACTIVE NOT RECRUITING

INECO Neurociencias Oroño

Rosario, 2000, Argentina

ACTIVE NOT RECRUITING

Instituto de Investigaciones Clinicas Rosario

Rosario, S2000CVD, Argentina

ACTIVE NOT RECRUITING

Centro de Investigaciones San Miguel

San Miguel, 1663, Argentina

ACTIVE NOT RECRUITING

AlergoAlpha - Barueri

Barueri, 06454-010, Brazil

ACTIVE NOT RECRUITING

PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR

Curitiba, 80230-130, Brazil

ACTIVE NOT RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, 90050-170, Brazil

ACTIVE NOT RECRUITING

Hospital São Lucas da PUCRS

Porto Alegre, 90610-000, Brazil

ACTIVE NOT RECRUITING

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, 20241-180, Brazil

ACTIVE NOT RECRUITING

Centro de Pesquisas da Clínica IBIS

Salvador, 41820-020, Brazil

ACTIVE NOT RECRUITING

Faculdade de Medicina do ABC

Santo André, 09060-870, Brazil

ACTIVE NOT RECRUITING

ISPEM - Instituto São José dos Campos em Pesquisas Médicas

São José dos Campos, 12243-280, Brazil

ACTIVE NOT RECRUITING

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, 04266-010, Brazil

ACTIVE NOT RECRUITING

Brunswick Dermatology Center

Fredericton, E3B 1G9, Canada

ACTIVE NOT RECRUITING

Maritime Dermatology

Halifax, B3K 5R3, Canada

COMPLETED

Lovegrove Dermatology

London, N6A 5R9, Canada

ACTIVE NOT RECRUITING

Skin Care West

Nanaimo, V9V 1A3, Canada

ACTIVE NOT RECRUITING

Kanata Allergy Clinic

Ottawa, K2T 0N7, Canada

ACTIVE NOT RECRUITING

SKiN Centre for Dermatology

Peterborough, K9J 5K2, Canada

COMPLETED

Centre de Recherche Saint-Louis

Sherbrooke, J1G 1X9, Canada

ACTIVE NOT RECRUITING

Eternal Springtime Dermatology

Thunder Bay, P7C 4Y7, Canada

ACTIVE NOT RECRUITING

North York Research Inc

Toronto, M2N 3A6, Canada

ACTIVE NOT RECRUITING

Dr. Samuel Sanchez PSC

Caguas, 00725, Puerto Rico

ACTIVE NOT RECRUITING

CMRC Headlands, LLC

San Juan, 00918, Puerto Rico

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: June 16, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

BR (9); US (35); CA (9); AR (11); PR (2)