A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-1)

July 29, 2026 updated by: Eli Lilly and Company

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
377

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Fundacion Respirar
      • Buenos Aires, Argentina, 1012
        • CONEXA Investigacion Clinica S.A.
      • Buenos Aires, Argentina, 1425
        • Instituto de Neumonología Y Dermatología
      • Buenos Aires, Argentina, 1426
        • Derma Internacional
      • Buenos Aires, Argentina, C1425DKG
        • Psoriahue
      • Rosario, Argentina, S2000DEJ
        • Fundacion Estudios Clinicos
  • Australia
      • Coorparoo, Australia, 4151
        • Cornerstone Dermatology
      • Randwick, Australia, 2031
        • Sydney Children's Hospital
      • Westmead, Australia, 2145
        • The Children's Hospital at Westmead
      • Woolloongabba, Australia, 4102
        • Veracity Clinical Research
  • Brazil
      • Barretos, Brazil, 14784400
        • Fundacao Pio XII - Hospital de Cancer de Barretos
      • Campinas, Brazil, 13060-803
        • Centro de Pesquisa São Lucas
      • Porto Alegre, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Ribeirão Preto, Brazil, 14051-140
        • Hospital de Clínicas de Ribeirão Preto
      • Rio de Janeiro, Brazil, 20241-180
        • IBPClin - Instituto Brasil de Pesquisa Clínica
      • Santo André, Brazil, 09060-870
        • Faculdade de Medicina do ABC
      • Sorocaba, Brazil, 18040-425
        • Clinica de Alergia Martti Antila
  • Canada
      • Calgary, Canada, T2J 7E1
        • Dermatology Research Institute
      • Mississauga, Canada, L4Y 4C5
        • DermEdge Research
  • Czechia
      • Prague, Czechia, 180 81
        • Fakultní nemocnice Bulovka
  • Germany
      • Bad Bentheim, Germany, 48455
        • Fachklinik Bad Bentheim
      • Darmstadt, Germany, 64283
        • Rosenpark Research GmbH
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
  • Japan
      • Asahikawa, Japan, 078-8510
        • Asahikawa Medical University Hospital
      • Fukuyama, Japan, 721-8511
        • Fukuyama City Hospital
      • Habikino, Japan, 583-8588
        • Osaka Habikino Medical Center
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Ina, Japan, 396-0033
        • Ina Central Hospital
      • Kumagaya, Japan, 360-0018
        • Enomoto Clinic
      • Kyoto, Japan, 602-8566
        • University Hospital,Kyoto Prefectural University of Medicine
      • Okayama, Japan, 700-8557
        • Okayama City General Medical Center Okayama City Hospital
      • Sagamihara, Japan, 252-0392
        • National Hospital Organization Sagamihara National Hospital
      • Sakai, Japan, 593-8324
        • Dermatology and Ophthalmology Kume Clinic
      • Toshima City, Japan, 170-0002
        • Sugamo Sengoku Dermatology
      • Toyoake, Japan, 470-1192
        • Fujita Health University
  • Mexico
      • Chihuahua City, Mexico, 31207
        • Scientia Investigacion Clinica S.C.
      • Cuernavaca, Mexico, 62290
        • PanAmerican Clinical Research - Cuernavaca
      • Mexico City, Mexico, 06720
        • Hospital Infantil de México Federico Gómez
      • Mexico City, Mexico, 06090
        • Hospital de Jesús Nazareno
      • Mexico City, Mexico, 06700
        • Trials in Medicine
      • Monterrey, Mexico, 64718
        • Eukarya PharmaSite
      • Monterrey, Mexico, 66460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
      • Veracruz, Mexico, 91900
        • Arké SMO S.A de C.V
      • Zapopan, Mexico, 45190
        • Instituto Dermatologico de Jalisco
  • Poland
      • Gdansk, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
      • Krakow, Poland, 31-559
        • Diamond Clinic
      • Lodz, Poland, 90-265
        • "DERMED" Centrum Medyczne Sp. z o.o.
      • Warsaw, Poland, 02-625
        • Centrum Medyczne Evimed
  • Spain
      • Esplugues de Llobregat, Spain, 08950
        • Hospital Sant Joan de Déu
      • Las, Spain, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrin
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28009
        • Hospital Infantil Universitario Nino Jesus
      • Madrid, Spain, 28006
        • Grupo Pedro Jaén
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra
  • Taiwan
      • Hsinchu, Taiwan, 300
        • National Taiwan University Hospital - Hsinchu branch
      • Kaohsiung Niao Sung Dist, Taiwan, 83301
        • Chang Gung Memorial Hospital at Kaohsiung
      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 105
        • Chang Gung Memorial Hospital-Taipei
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Clinical Research Center of Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • Arkansas
      • North Little Rock, Arkansas, United States, 72217
        • Arkansas Research Trials
    • California
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology
      • Lancaster, California, United States, 93534
        • Antelope Valley Clinical Trials
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Sacramento, California, United States, 95815
        • Integrative Skin Science and Research
      • San Diego, California, United States, 92123
        • Rady's Children Hospital San Diego - Dermatology
    • Connecticut
      • Farmington, Connecticut, United States, 06030-2840
        • UConn Health
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Solutions Through Advanced Research
      • Tampa, Florida, United States, 33613
        • ForCare Clinical Research
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Allergy & Asthma Specialists, P.S.C.
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Respiratory Medicine Research Institute of Michigan, PLC
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Psoriasis Treatment Center of Central New Jersey
    • Ohio
      • Fairborn, Ohio, United States, 45324
        • Dermatologists of Central States, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lebrikizumab (Cohort 1)

Participants 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.
Drug: Lebrikizumab
Administered SC
Other Names:
  • LY3650150
  • DRM06
Drug: Topical Corticosteroid (TCS)
TCS administered
Experimental: Lebrikizumab (Cohort 2)

Participants 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.
Drug: Lebrikizumab
Administered SC
Other Names:
  • LY3650150
  • DRM06
Drug: Topical Corticosteroid (TCS)
TCS administered
Placebo Comparator: Placebo
Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
Drug: Placebo
Placebo given SC
Drug: Topical Corticosteroid (TCS)
TCS administered

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
EASI-75 is a co-primary endpoint with IGA.
Baseline to Week 16
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score
Time Frame: Baseline to Week 16
IGA is a co-primary endpoint with EASI-75.
Baseline to Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage Change from Baseline in Pruritus NRS Score
Time Frame: Baseline, Week 16
Baseline, Week 16
Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score
Time Frame: Baseline to Week 16
Baseline to Week 16
Percentage Change from Baseline in EASI Score
Time Frame: Baseline, Week 16
Baseline, Week 16
Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline
Time Frame: Baseline to Week 16
Baseline to Week 16
Change from Baseline in Children Dermatology Life Quality Index (cDLQI)
Time Frame: Baseline, Week 16
Baseline, Week 16
Change from Baseline in Body Surface Area (BSA)
Time Frame: Baseline, Week 16
Baseline, Week 16
Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD)
Time Frame: Baseline, Week 16
Baseline, Week 16
Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score
Time Frame: Baseline to Week 16
Baseline to Week 16
Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration
Time Frame: Week 14
Week 14
Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS)
Time Frame: Baseline, Week 16
Baseline, Week 16
Percentage of Participants with a cDLQI of ≥6 points at Baseline Achieving ≥6-point Improvement in cDLQI from Baseline to Week 16
Time Frame: Baseline to Week 16
Baseline to Week 16
Percentage of Participants with Positive Responses by the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)
Time Frame: Week 14
Week 14
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
Time Frame: Baseline to Week 16
Baseline to Week 16
Change from Baseline in SCORAD
Time Frame: Baseline, Week 16
Baseline, Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dermira, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18265
  • J2T-MC-KGBI (Other Identifier: Eli Lilly and Company)
  • DRM06-AD13 (Other Identifier: Dermira Inc)
  • 2021-005232-29 (EudraCT Number)
  • 2022-501476-25-00 (Other Identifier: EU Trial Number)

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 European Union (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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