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

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: Active, not recruiting
• Conditions: Eczema; Atopic Dermatitis
• Intervention / Treatment: Drug: Lebrikizumab; Drug: Placebo; Drug: Topical Corticosteroid (TCS)

• Study Type: Interventional
• Enrollment (Actual): 367
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Fundación Respirar
  • Buenos Aires, Argentina, 1012
    • CONEXA Investigacion Clinica S.A.
  • Buenos Aires, Argentina, 1425
    • Instituto de Neumonologia Y Dermatologia
  • 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
    • Fundação Pio XII - Hospital de Câncer 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
    • Fakultni 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 Mexico Federico Gomez
  • 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 Niño Jesús
  • 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 District, 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	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	IGA is a co-primary endpoint with EASI-75.	Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage Change from Baseline in Pruritus NRS Score	Baseline, Week 16
Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score	Baseline to Week 16
Percentage Change from Baseline in EASI Score	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	Baseline to Week 16
Change from Baseline in Children Dermatology Life Quality Index (cDLQI)	Baseline, Week 16
Change from Baseline in Body Surface Area (BSA)	Baseline, Week 16
Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD)	Baseline, Week 16
Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score	Baseline to Week 16
Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration	Week 14
Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS)	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	Baseline to Week 16
Percentage of Participants with Positive Responses by the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)	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	Baseline to Week 16
Change from Baseline in SCORAD	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Dermira, Inc.
• 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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Actual): January 14, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 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; Eczema; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; lebrikizumab; Adrenal Cortex Hormones
• Other Study ID 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