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

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

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

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Lebrikizumab

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Fundación Respirar
  • Buenos Aires, Argentina, C1425BEA
    • Instituto de Neumonologia y Dermatologia
  • Buenos Aires, Argentina, 1012
    • CONEXA Investigacion Clinica S.A.
  • Buenos Aires, Argentina, 1061
    • CIPREC
  • Buenos Aires, Argentina, C1056ABI
    • Centro de Investigaciones Metabólicas (CINME)
  • Buenos Aires, Argentina, C1111
    • DOM Centro de Reumatología
  • Buenos Aires, Argentina, C1425DKG
    • Psoriahue
  • Mendoza, Argentina, 5500
    • Parra Dermatología
  • Rosario, Argentina, 2000
    • INECO Neurociencias Orono
  • Rosario, Argentina, S2000CVD
    • Instituto de Investigaciones Clinicas Rosario
  • San Miguel, Argentina, 1663
    • Centro de Investigaciones San Miguel
• Brazil
  • Barueri, Brazil, 06454-010
    • AlergoAlpha - Barueri
  • Curitiba, Brazil, 80230-130
    • PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
  • Porto Alegre, Brazil, 90050-170
    • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 90610-000
    • Hospital Sao Lucas da PUCRS
  • Rio de Janeiro, Brazil, 20241-180
    • IBPClin - Instituto Brasil de Pesquisa Clínica
  • Salvador, Brazil, 41820-020
    • Centro de Pesquisas da Clínica IBIS
  • Santo André, Brazil, 09060-870
    • Faculdade de Medicina do ABC
  • São José dos Campos, Brazil, 12243-280
    • ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
  • São Paulo, Brazil, 04266-010
    • CEPIC - Centro Paulista de Investigação Clínica
• Canada
  • Fredericton, Canada, E3B 1G9
    • Brunswick Dermatology Center
  • Halifax, Canada, B3K 5R3
    • Maritime Dermatology
  • London, Canada, N6A 5R9
    • Lovegrove Dermatology
  • Nanaimo, Canada, V9V 1A3
    • Skin Care West
  • Ottawa, Canada, K2T 0N7
    • Kanata Allergy Clinic
  • Peterborough, Canada, K9J 5K2
    • Skin Centre for Dermatology
  • Sherbrooke, Canada, J1G 1X9
    • Centre de Recherche Saint-Louis
  • Thunder Bay, Canada, P7C 4Y7
    • Eternal Springtime Dermatology
  • Toronto, Canada, M2N 3A6
    • North York Research Inc
• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Dr. Samuel Sanchez PSC
  • San Juan, Puerto Rico, 00918
    • CMRC Headlands, LLC
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35203
      • Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • Research Solutions of Arizona
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology and Mohs Center
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Rocklin, California, United States, 95765
      • Norcal Clinical Research
  • Florida
    • Doral, Florida, United States, 33172
      • Suncoast Research Associates
    • Hollywood, Florida, United States, 33024
      • Encore Medical Research
    • Jacksonville, Florida, United States, 32256
      • Solutions Through Advanced Research
    • Miami, Florida, United States, 33126
      • Life Arc Research Centers - Miami
    • Miami, Florida, United States, 33126
      • MCR Research
    • Miami, Florida, United States, 33176
      • Health Clinical Research
    • Miami Lakes, Florida, United States, 33014
      • Deluxe Health Center
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Plantation, Florida, United States, 33317
      • Leading Edge Dermatology
  • Georgia
    • Atlanta, Georgia, United States, 30305
      • Dermatology Affiliates Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60602
      • DeNova Research
  • Indiana
    • Columbus, Indiana, United States, 47201
      • Southern Indiana Clinical Research Center
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
    • New Albany, Indiana, United States, 47150
      • Southern Indiana Clinical trials
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Equity Medical - Bowling Green
    • Owensboro, Kentucky, United States, 42301
      • Allergy & Asthma Specialists, P.S.C.
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Foxhall Research Center
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10023
      • Equity Medical
  • North Carolina
    • Hickory, North Carolina, United States, 28602
      • Hickory Dermatology Research Center
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • ObjectiveHealth - Goodlettsville Dermatology Research
  • Texas
    • Frisco, Texas, United States, 75033
      • Reveal Research Institute - Frisco
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, LLC
    • Mansfield, Texas, United States, 76063
      • Prime Clinical Research - Mansfield
    • San Antonio, Texas, United States, 78235
      • Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
  • Utah
    • South Jordan, Utah, United States, 84095
      • Jordan Valley Dermatology & Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lebrikizumab; Lebrikizumab administered subcutaneously (SC).	Drug: Lebrikizumab; Administered SC; Other Names: LY3650150

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Percentage of Change from Baseline in Pruritus NRS Score	Baseline, Week 24
Percentage of Participants with a Sleep-loss Scale Score of ≥2 points at Baseline Who Achieve a ≥ 2-point Reduction	Baseline to Week 24
Percentage Change from Baseline in Sleep-loss Scale	Baseline, Week 24
Percentage of Participants with a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction	Baseline to Week 24
Change from Baseline in Dermatology Quality of Life (DLQI)	Baseline, Week 24
Change from Baseline in Children's Dermatology Quality of Life (CDLQI)	Baseline, Week 24

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Actual): May 14, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 28, 2025
• First Submitted That Met QC Criteria: May 28, 2025
• First Posted (Actual): June 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; lebrikizumab
• Other Study ID Numbers: 27407; J2T-MC-KGCE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No