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Atopic DermatitisPhase 4ADsolveNCT07006792

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

A Phase 4 study testing Lebrikizumab in people with Atopic Dermatitis, run by Eli Lilly and Company at 66 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Lebrikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
233 participants
Where
66 sitesin 5 countries
Study dates
16 Jun 2025to 21 Sep 2026
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

66 sites in 5 countries.

66 sites in 5 countries

United States35 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Dermatology Affiliates Research Institute

    Atlanta, Georgia, 30305

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology

    Birmingham, Alabama, 35203

  • Equity Medical - Bowling Green

    Bowling Green, Kentucky, 42104

  • Foxhall Research Center

    Chevy Chase, Maryland, 20815

  • DeNova Research

    Chicago, Illinois, 60602

  • Southern Indiana Clinical Research Center

    Columbus, Indiana, 47201

  • Suncoast Research Associates

    Doral, Florida, 33172

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024

  • Reveal Research Institute - Frisco

    Frisco, Texas, 75033

  • ObjectiveHealth - Goodlettsville Dermatology Research

    Goodlettsville, Tennessee, 37072

  • Hickory Dermatology Research Center

    Hickory, North Carolina, 28602

  • Encore Medical Research

    Hollywood, Florida, 33024

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Solutions Through Advanced Research

    Jacksonville, Florida, 32256

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Prime Clinical Research - Mansfield

    Mansfield, Texas, 76063

  • Life Arc Research Centers - Miami

    Miami, Florida, 33126

  • MCR Research

    Miami, Florida, 33126

  • Health Clinical Research

    Miami, Florida, 33176

  • Deluxe Health Center

    Miami Lakes, Florida, 33014

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150

  • Equity Medical

    New York, New York, 10023

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Allergy & Asthma Specialists, P.S.C.

    Owensboro, Kentucky, 42301

  • Alliance Dermatology and Mohs Center

    Phoenix, Arizona, 85032

  • Leading Edge Dermatology

    Plantation, Florida, 33317

  • NorCal Clinical Research

    Rocklin, California, 95765

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

    San Antonio, Texas, 78235

  • Jordan Valley Dermatology & Research Center

    South Jordan, Utah, 84095

  • Revival Research Institute, LLC

    Troy, Michigan, 48084

Other trials in United States

Argentina11 sites

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012

  • CIPREC

    Buenos Aires, 1061

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI

  • DOM Centro de Reumatología

    Buenos Aires, C1111

  • Instituto de Neumonologia Y Dermatologia

    Buenos Aires, C1425BEA

  • Psoriahue

    Buenos Aires, C1425DKG

  • Fundación Respirar

    Buenos Aires, C1426ABP

  • Parra Dermatología

    Mendoza, 5500

  • INECO Neurociencias Oroño

    Rosario, 2000

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, S2000CVD

  • Centro de Investigaciones San Miguel

    San Miguel, 1663

Other trials in Argentina

Brazil9 sites

  • AlergoAlpha - Barueri

    Barueri, 06454-010

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

    Curitiba, 80230-130

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90050-170

  • Hospital São Lucas da PUCRS

    Porto Alegre, 90610-000

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180

  • Centro de Pesquisas da Clínica IBIS

    Salvador, 41820-020

  • Faculdade de Medicina do ABC

    Santo André, 09060-870

  • ISPEM - Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos, 12243-280

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010

Other trials in Brazil

Canada9 sites

  • Brunswick Dermatology Center

    Fredericton, E3B 1G9

  • Maritime Dermatology

    Halifax, B3K 5R3

  • Lovegrove Dermatology

    London, N6A 5R9

  • Skin Care West

    Nanaimo, V9V 1A3

  • Kanata Allergy Clinic

    Ottawa, K2T 0N7

  • SKiN Centre for Dermatology

    Peterborough, K9J 5K2

  • Centre de Recherche Saint-Louis

    Sherbrooke, J1G 1X9

  • Eternal Springtime Dermatology

    Thunder Bay, P7C 4Y7

  • North York Research Inc

    Toronto, M2N 3A6

Other trials in Canada

Puerto Rico2 sites

  • Dr. Samuel Sanchez PSC

    Caguas, 00725

  • CMRC Headlands, LLC

    San Juan, 00918

Other trials in Puerto Rico

About this study

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

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.

Being tested
Lebrikizumab
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LebrikizumabDrug

    Also called LY3650150

    Administered SC

Study groups in NCT07006792
Study groupRoleWhat they receive
LebrikizumabExperimentalLebrikizumab administered subcutaneously (SC).
Receives: Drug: Lebrikizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 16

Secondary outcomes (11)

  1. Percentage of Participants Achieving EASI-75

    Measured: Baseline to Week 24

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

    Measured: Baseline to Week 24

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

    Measured: Baseline to Week 24

  4. Percentage of Participants Achieving EASI-90

    Measured: Baseline to Week 24

  5. Change from Baseline in Body Surface Area (BSA) Involvement

    Measured: Baseline, Week 24

  6. Percentage of Change from Baseline in Pruritus NRS Score

    Measured: Baseline, Week 24

  7. Percentage of Participants with a Sleep-loss Scale Score of ≥2 points at Baseline Who Achieve a ≥ 2-point Reduction

    Measured: Baseline to Week 24

  8. Percentage Change from Baseline in Sleep-loss Scale

    Measured: Baseline, Week 24

  9. Percentage of Participants with a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction

    Measured: Baseline to Week 24

  10. Change from Baseline in Dermatology Quality of Life (DLQI)

    Measured: Baseline, Week 24

  11. Change from Baseline in Children's Dermatology Quality of Life (CDLQI)

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2025
  2. Study start16 Jun 2025
  3. Primary completion14 May 2026
  4. Study completion21 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07006792
Sponsor's protocol ID
27407
Other IDs
J2T-MC-KGCE
Acronym
ADsolve
Status last verified
Oct 2026
First submitted
28 May 2025
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

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