AzTrials
AzTrials

Atopic DermatitisPhase 3ADorable-1NCT05559359

A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

A Phase 3 study testing Lebrikizumab and Topical Corticosteroid (TCS) in people with Atopic Dermatitis and Eczema, run by Eli Lilly and Company at 85 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD). Read more about this study

Who is it for?
Ages 6 months to 17 years
Conditions the study is for
Atopic Dermatitis, Eczema
What is being tested?
Lebrikizumab and Topical Corticosteroid (TCS)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
377 participants
Where
85 sitesin 12 countries
Study dates
18 Oct 2022to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 6 months to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least,
  • 12 months if participants are ≥6 years of age
  • 6 months if participants are 2 to <6 years of age
  • 3 months if participants are 6 months to <2 years of age.
  • Have an EASI score ≥16 at the screening and baseline
  • Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline
  • Have ≥10% BSA of AD involvement at the screening and baseline.

Who cannot join

  • Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Treatment with the following prior to the baseline:
  • An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer.
  • Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to <20%.
  • Treatment with a topical investigational drug within 2 weeks prior to the baseline.
  • Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.

Trial locations and contacts

85 sites in 12 countries.

85 sites in 12 countries

United States21 sites

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35209

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520

  • Dermatologists of Central States, LLC

    Fairborn, Ohio, 45324

  • UConn Health

    Farmington, Connecticut, 06030-2840

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Solutions Through Advanced Research

    Jacksonville, Florida, 32256

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72217

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

    Owensboro, Kentucky, 42301

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • Integrative Skin Science and Research

    Sacramento, California, 95815

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • Rady's Children Hospital San Diego - Dermatology

    San Diego, California, 92123

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan12 sites

  • Asahikawa Medical University Hospital

    Asahikawa, 078-8510

  • Fukuyama City Hospital

    Fukuyama, 721-8511

  • Osaka Habikino Medical Center

    Habikino, 583-8588

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Ina Central Hospital

    Ina, 396-0033

  • Enomoto Clinic

    Kumagaya, 360-0018

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, 700-8557

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, 252-0392

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, 593-8324

  • Sugamo Sengoku Dermatology

    Toshima City, 170-0002

  • Fujita Health University

    Toyoake, 470-1192

Other trials in Japan

Mexico9 sites

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31207

  • PanAmerican Clinical Research - Cuernavaca

    Cuernavaca, 62290

  • Hospital de Jesús Nazareno

    Mexico City, 06090

  • Trials in Medicine

    Mexico City, 06700

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, 06720

  • Eukarya PharmaSite

    Monterrey, 64718

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, 66460

  • Arké SMO S.A de C.V

    Veracruz, 91900

  • Instituto Dermatologico de Jalisco

    Zapopan, 45190

Other trials in Mexico

Brazil7 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, 14784400

  • Centro de Pesquisa Sao Lucas

    Campinas, 13060-803

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Hospital de Clínicas de Ribeirão Preto

    Ribeirão Preto, 14051-140

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180

  • Faculdade de Medicina do ABC

    Santo André, 09060-870

  • Clinica de Alergia Martti Antila

    Sorocaba, 18040-425

Other trials in Brazil

Spain7 sites

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, 08950

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las, 35010

  • Grupo Pedro Jaén

    Madrid, 28006

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Clinica Universidad de Navarra

    Pamplona, 31008

Other trials in Spain

Taiwan7 sites

  • National Taiwan University Hospital - Hsinchu branch

    Hsinchu, 300

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, 83301

  • Chung Shan Medical University Hospital

    Taichung, 402

  • National Taiwan University Hospital

    Taipei, 10002

  • Chang Gung Memorial Hospital-Taipei

    Taipei, 105

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Argentina6 sites

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012

  • Instituto de Neumonología Y Dermatología

    Buenos Aires, 1425

  • Derma Internacional

    Buenos Aires, 1426

  • Psoriahue

    Buenos Aires, C1425DKG

  • Fundación Respirar

    Buenos Aires, C1426ABP

  • Fundacion Estudios Clinicos

    Rosario, S2000DEJ

Other trials in Argentina

Germany5 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455

  • Rosenpark Research GmbH

    Darmstadt, 64283

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

  • Universitätsklinikum Münster

    Münster, 48149

Other trials in Germany

Australia4 sites

  • Cornerstone Dermatology

    Coorparoo, 4151

  • Sydney Children's Hospital

    Randwick, 2031

  • The Children's Hospital at Westmead

    Westmead, 2145

  • Veracity Clinical Research

    Woolloongabba, 4102

Other trials in Australia

Poland4 sites

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, 80-546

  • Diamond Clinic

    Krakow, 31-559

  • "DERMED" Centrum Medyczne Sp. z o.o.

    Lodz, 90-265

  • Centrum Medyczne Evimed

    Warsaw, 02-625

Other trials in Poland

Canada2 sites

  • Dermatology Research Institute

    Calgary, T2J 7E1

  • DermEdge Research

    Mississauga, L4Y 4C5

Other trials in Canada

Czechia1 site

  • Fakultni nemocnice Bulovka

    Prague, 180 81

Other trials in Czechia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD).

Being tested
Lebrikizumab, Placebo, Topical Corticosteroid (TCS)
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

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

  • LebrikizumabDrug

    Also called LY3650150, DRM06

    Administered SC

  • PlaceboDrug

    Placebo given SC

  • Topical Corticosteroid (TCS)Drug

    TCS administered

Study groups in NCT05559359
Study groupRoleWhat they receive
Lebrikizumab (Cohort 1)ExperimentalParticipants who are 6 years to <18 years of age, 12 years to <18 years of age who weigh <40 kilogram (kg) or 6 years to <12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS). Dosing will be based on weight.
Receives: Drug: Lebrikizumab; Drug: Topical Corticosteroid (TCS)
Lebrikizumab (Cohort 2)ExperimentalParticipants who are 6 months to <6 years of age, 2 years to <6 years of age or 6 months to <2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS. Dosing will be based on weight.
Receives: Drug: Lebrikizumab; Drug: Topical Corticosteroid (TCS)
PlaceboPlacebo comparatorParticipants will receive placebo matching lebrikizumab by SC injections with a TCS.
Receives: Drug: Placebo; Drug: Topical Corticosteroid (TCS)

What is being measured

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

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

    EASI-75 is a co-primary endpoint with IGA.

    Measured: Baseline to Week 16

  2. Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score

    IGA is a co-primary endpoint with EASI-75.

    Measured: Baseline to Week 16

Secondary outcomes (14)

  1. Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score

    Measured: Baseline to Week 16

  2. Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline

    Measured: Baseline to Week 16

  3. Percentage of Participants with a cDLQI of ≥6 points at Baseline Achieving ≥6-point Improvement in cDLQI from Baseline to Week 16

    Measured: Baseline to Week 16

  4. Percentage Change from Baseline in EASI Score

    Measured: Baseline, Week 16

  5. Percentage Change from Baseline in Pruritus NRS Score

    Measured: Baseline, Week 16

  6. Change from Baseline in Children Dermatology Life Quality Index (cDLQI)

    Measured: Baseline, Week 16

  7. Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS)

    Measured: Baseline, Week 16

  8. Change from Baseline in Body Surface Area (BSA)

    Measured: Baseline, Week 16

  9. Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD)

    Measured: Baseline, Week 16

  10. Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score

    Measured: Baseline to Week 16

  11. Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration

    Measured: Week 14

  12. Percentage of Participants with Positive Responses by the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)

    Measured: Week 14

  13. Percentage of Participants with a Worst Scratching/Itching NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline to Week 16

    Measured: Baseline to Week 16

  14. Change from Baseline in SCORAD

    Measured: Baseline, Week 16

Timeline

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

  1. First posted29 Sep 2022
  2. Study start18 Oct 2022
  3. Primary completion14 Jan 2026
  4. Study completionDec 2026 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05559359
Sponsor's protocol ID
18265
Other IDs
J2T-MC-KGBI, DRM06-AD13, 2021-005232-29, 2022-501476-25-00
Acronym
ADorable-1
Status last verified
Jan 2026
First submitted
26 Sep 2022
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lebrikizumab and Topical Corticosteroid (TCS) in people with Atopic Dermatitis and Eczema, run by Eli Lilly and Company at 85 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Japan, Mexico, Brazil, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline (time frame: Baseline to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05559359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in