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

April 16, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • 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

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559)
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Recruiting
        • Fundacion Respirar
        • Contact:
          • Phone Number: 541170781548
        • Principal Investigator:
          • Maria Florencia Fernández
      • Buenos Aires, Argentina, 1012
        • Recruiting
        • Conexa Investigacion Clinica S.A.
        • Contact:
          • Phone Number: 541139899011
        • Principal Investigator:
          • Pablo Javier Gonzalez
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1425DKG
        • Recruiting
        • Psoriahue
        • Contact:
          • Phone Number: 541148238755
        • Principal Investigator:
          • Gabriel Alejandro Magariños
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, 1425
        • Recruiting
        • Instituto de Neumonologia y Dermatologia
        • Contact:
          • Phone Number: 541148230919
        • Principal Investigator:
          • Paula Carolina Luna
    • Ciudad Autónoma De Buenos Aires
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1121ABE
        • Recruiting
        • Fundacion Cidea
        • Contact:
          • Phone Number: 541153521290
        • Principal Investigator:
          • Jorge Fernando Máspero
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DEJ
        • Recruiting
        • Fundacion Estudios Clinicos
        • Principal Investigator:
          • Maria Fernanda Maccario
  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Sydney Children's Hospital
        • Contact:
          • Phone Number: 61299117277
        • Principal Investigator:
          • Linda Martin
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • The Children's Hospital at Westmead
        • Contact:
          • Phone Number: 0403130173
        • Principal Investigator:
          • Li-Chuen Wong
    • Queensland
      • Coorparoo, Queensland, Australia, 4151
        • Recruiting
        • Cornerstone Dermatology
        • Principal Investigator:
          • Young Jin Kim
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Veracity Clinical Research Pty Ltd
        • Contact:
          • Phone Number: 001161730391300
        • Principal Investigator:
          • Lynda Spelman
  • Brazil
      • Rio de Janeiro, Brazil, 20241-180
        • Recruiting
        • IBPClin - Instituto Brasil de Pesquisa Clínica
        • Principal Investigator:
          • ANA DALTRO FILGUEIRAS
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
          • Phone Number: 555133598571
        • Principal Investigator:
          • Tania Cestari
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784400
        • Recruiting
        • Fundação Pio XII - Hospital de Câncer de Barretos
        • Principal Investigator:
          • Bruno Augusto Alvares
      • Campinas, São Paulo, Brazil, 13060-803
        • Recruiting
        • Centro de Pesquisa Sao Lucas
        • Principal Investigator:
          • Livia Matida Gontijo Leal
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
        • Recruiting
        • Hospital de Clínicas de Ribeirão Preto
        • Principal Investigator:
          • Roberto Bueno Filho
      • Santo Andre, São Paulo, Brazil, 09060-870
        • Recruiting
        • Faculdade de Medicina do ABC
        • Contact:
          • Phone Number: 1149935459
        • Principal Investigator:
          • Roberta Fachini Jardim Criado
      • Santo André, São Paulo, Brazil, 09080-110
        • Recruiting
        • Pesquisare Saude
        • Contact:
          • Phone Number: 11980832323
        • Principal Investigator:
          • Paulo Ricardo Criado
      • Sorocaba, São Paulo, Brazil, 18040-425
        • Recruiting
        • Clinica de Alergia Martti Antila
        • Principal Investigator:
          • MARTTI ANTILA
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Recruiting
        • Dermatology Research Institute
        • Contact:
          • Phone Number: 4032633376
        • Principal Investigator:
          • Vimal Hasmukh Prajapati
      • Edmonton, Alberta, Canada, T6G 1C3
        • Recruiting
        • Alberta DermaSurgery Centre
        • Principal Investigator:
          • Jaggi Rao
    • Ontario
      • Mississauga, Ontario, Canada, L4Y 4C5
        • Recruiting
        • DermEdge Research
        • Contact:
          • Phone Number: 9052749996
        • Principal Investigator:
          • Mark Lomaga
  • Czechia
    • Brno-město
      • Brno, Brno-město, Czechia, 613 00
        • Recruiting
        • Detska nemocnice FN Brno
        • Principal Investigator:
          • Blanka Pinkova
    • Praha 8
      • Prague, Praha 8, Czechia, 180 81
        • Recruiting
        • Fakultni nemocnice Bulovka
        • Principal Investigator:
          • Filip Rob
  • France
    • Drôme
      • Romans-sur-Isère, Drôme, France, 26102
        • Recruiting
        • Hôpitaux Drôme Nord - Romans
        • Contact:
          • Phone Number: 33047568378
        • Principal Investigator:
          • Francois Skowron
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093 Cedex 1
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
        • Principal Investigator:
          • Sebastien Barbarot
    • Midi-Pyrénées
      • Toulouse, Midi-Pyrénées, France, 31400
        • Recruiting
        • CHU de Toulouse - Hopital Larrey
        • Principal Investigator:
          • Maella Severino-Freire
  • Germany
    • Hessen
      • Darmstadt, Hessen, Germany, 64283
        • Recruiting
        • Rosenpark Research GmbH
        • Principal Investigator:
          • Oliver Weirich
      • Frankfurt, Hessen, Germany, 60590
        • Recruiting
        • Universitätsklinikum Frankfurt
        • Principal Investigator:
          • Andreas Pinter
    • Niedersach
      • Bad Bentheim, Niedersach, Germany, 48455
        • Recruiting
        • Fachklinik Bad Bentheim
        • Contact:
          • Phone Number: 495922745290
        • Principal Investigator:
          • Athanasios Tsianakas
    • Nordrhein-Westfalen
      • Münster, Nordrhein-Westfalen, Germany, 48149
        • Recruiting
        • Universitatsklinikum Munster
        • Contact:
          • Phone Number: 00492518356558
        • Principal Investigator:
          • Nina Magnolo
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden
        • Contact:
          • Phone Number: 49351458340
        • Principal Investigator:
          • Susanne Abraham
  • Japan
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital
        • Principal Investigator:
          • Akio Tanaka
      • Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital,Kyoto Prefectural University of Medicine
        • Principal Investigator:
          • Koji Masuda
      • Okayama, Japan, 700-8557
        • Recruiting
        • Okayama City General Medical Center Okayama City Hospital
        • Principal Investigator:
          • Akira Manki
    • Aichi
      • Toyoake, Aichi, Japan, 470-1192
        • Recruiting
        • Fujita Health University
        • Principal Investigator:
          • Kazumitsu Sugiura
    • Hiroshima
      • Fukuyama, Hiroshima, Japan, 721-8511
        • Recruiting
        • Fukuyama City Hospital
        • Principal Investigator:
          • Masanori Ikeda
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8510
        • Recruiting
        • Asahikawa Medical College Hospital
        • Principal Investigator:
          • Satomi Igawa
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0392
        • Recruiting
        • National Hospital Organization Sagamihara National Hospital
        • Contact:
          • Phone Number: 0427428311
        • Principal Investigator:
          • Motohiro Ebisawa
    • Nagano
      • Ina, Nagano, Japan, 396-0033
        • Recruiting
        • Ina Central Hospital
        • Principal Investigator:
          • MASAO FUKUZAWA
    • Osaka
      • Sakai City, Osaka, Japan, 593-8324
        • Recruiting
        • Kume Clinic
        • Principal Investigator:
          • Akihiro Kume
    • Saitama
      • Kumagaya, Saitama, Japan, 360-0018
        • Recruiting
        • Enomoto Clinic
        • Principal Investigator:
          • Shinya Enomoto
    • Tokyo
      • Toshima, Tokyo, Japan, 170-0002
        • Recruiting
        • Sugamo Sengoku Dermatology
        • Principal Investigator:
          • Maaya Konishi
  • Mexico
      • Chihuahua, Mexico, 31207
        • Recruiting
        • Scientia Investigacion Clinica S.C.
        • Contact:
          • Phone Number: 6146883416
        • Principal Investigator:
          • Mavi Patricia Lopez
      • Veracruz, Mexico, 91910
        • Recruiting
        • Arké SMO S.A de C.V
        • Contact:
          • Phone Number: 2299314102
        • Principal Investigator:
          • Claudia Bernabe del Rio
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 06720
        • Recruiting
        • Hospital Infantil de Mexico Federico Gomez
        • Contact:
          • Phone Number: 525554331566
        • Principal Investigator:
          • MIRNA ERENDIRA TOLEDO BAHENA
      • Mexico City, Distrito Federal, Mexico, 06090
        • Recruiting
        • Hospital de Jesús Nazareno
        • Contact:
          • Phone Number: 5528880413
        • Principal Investigator:
          • Luis Hernandez
      • Mexico City, Distrito Federal, Mexico, 06700
        • Recruiting
        • Trials in Medicine
        • Contact:
          • Phone Number: 525551625211
        • Principal Investigator:
          • Diana Fernandez
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45190
        • Not yet recruiting
        • Instituto Dermatologico de Jalisco
        • Principal Investigator:
          • FRANCISCO SALAZAR
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • Recruiting
        • PanAmerican Clinical Research - Cuernavaca
        • Contact:
          • Phone Number: 7771442353
        • Principal Investigator:
          • Patricia Sepulveda
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66460
        • Recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
        • Principal Investigator:
          • Gloria Maria Rosales Solis
      • Monterrey, Nuevo León, Mexico, 64718
        • Recruiting
        • Eukarya Pharmasite
        • Contact:
          • Phone Number: 8183463307
        • Principal Investigator:
          • Daniel Gonzalez Gaytan
  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-625
        • Recruiting
        • Centrum Medyczne Evimed
        • Contact:
          • Phone Number: 48510175635
        • Principal Investigator:
          • Monika Slowinska
    • Małopolskie
      • Krakow, Małopolskie, Poland, 31-559
        • Recruiting
        • Diamond Clinic
        • Contact:
          • Phone Number: 4869604902
        • Principal Investigator:
          • Barbara Rewerska
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Recruiting
        • Centrum Badan Klinicznych PI-House Sp. z o.o.
        • Contact:
          • Phone Number: 48513104911
        • Principal Investigator:
          • Aleksandra Okuniewska
    • Łódzkie
      • Lodz, Łódzkie, Poland, 90-265
        • Recruiting
        • Dermed Centrum Medyczne Sp. z o.o.
        • Contact:
          • Phone Number: 48426631444
        • Principal Investigator:
          • Aleksandra Kaszuba
  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Phone Number: 917792261
        • Principal Investigator:
          • Sara Isabel Palencia Perez
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Raul de Lucas Laguna
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital Infantil Universitario Niño Jesús
        • Contact:
          • Phone Number: 915035900
        • Principal Investigator:
          • Antonio Torrelo Fernandez
      • Madrid, Spain, 28006
        • Recruiting
        • Grupo Pedro Jaén
        • Principal Investigator:
          • Alvaro Gonzalez-Cantero
    • Barcelona [Barcelona]
      • Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
        • Recruiting
        • Hospital Sant Joan de Deu
        • Contact:
          • Phone Number: 932804000
        • Principal Investigator:
          • Eulalia Baselga
    • Las Palmas
      • Las, Las Palmas, Spain, 35010
        • Recruiting
        • Hospital Universitario de Gran Canaria Doctor Negrin
        • Principal Investigator:
          • ALICIA LOURDES GONZALEZ QUESADA
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Recruiting
        • Hospital Universitario Quironsalud Madrid
        • Contact:
          • Phone Number: 0034647415381
        • Principal Investigator:
          • Javier Pedraz
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clínica Universidad de Navarra
        • Contact:
          • Phone Number: 34948255400
        • Principal Investigator:
          • Nuria Rodriguez-Garijo
    • Pontevedra [Pontevedra]
      • Pontevedra, Pontevedra [Pontevedra], Spain, 36001
        • Recruiting
        • CHOP-Centro De Especialidades De Mollabao
        • Contact:
          • Phone Number: 0034986800272
        • Principal Investigator:
          • Maria Teresa Abalde Pintos
    • València
      • Manises, València, Spain, 46940
        • Recruiting
        • Hospital de Manises
        • Contact:
          • Phone Number: 961845065
        • Principal Investigator:
          • Antonio Martorell
  • Taiwan
      • Hsinchu, Taiwan, 300
        • Recruiting
        • National Taiwan University Hospital - Hsinchu branch
        • Contact:
          • Phone Number: 88635326151
        • Principal Investigator:
          • HSIEN-YI CHIU
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Phone Number: 886223562141
        • Principal Investigator:
          • Chia-Yu Chu
      • Taipei, Taiwan, 105
        • Recruiting
        • Chang Gung Memorial Hospital-Taipei
        • Contact:
          • Phone Number: 886227135211
        • Principal Investigator:
          • Yu-Huei Huang
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch
        • Principal Investigator:
          • Chin-Yi Yang
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung
        • Contact:
          • Phone Number: 8867317123229
        • Principal Investigator:
          • Ji-Chen Ho
    • Taichung
      • Taichung City, Taichung, Taiwan, 402
        • Recruiting
        • Chung Shan Medical University Hospital
        • Contact:
          • Phone Number: 8862473959534
        • Principal Investigator:
          • Po-Ju Lai
    • Taipei
      • Taipei City, Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Phone Number: 0228757339
        • Principal Investigator:
          • Chih-Chiang Chen
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • Clinical Research Center of Alabama
        • Principal Investigator:
          • Weily Soong
        • Contact:
          • Phone Number: 205-209-4101
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
        • Principal Investigator:
          • Harper Price
    • Arkansas
      • North Little Rock, Arkansas, United States, 72217
        • Recruiting
        • Arkansas Research Trials
        • Contact:
          • Phone Number: 5016211100
        • Principal Investigator:
          • Scott Michael Dinehart
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • First Oc Dermatology
        • Principal Investigator:
          • Vivian Laquer
      • Lancaster, California, United States, 93534
        • Recruiting
        • Antelope Valley Clinical Trials
        • Principal Investigator:
          • Ricardo Antonio Tan
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Dermatology Research Associates
        • Contact:
          • Phone Number: 310-337-7171
        • Principal Investigator:
          • Howard Sofen
      • Sacramento, California, United States, 95815
        • Recruiting
        • Integrative Skin Science and Research - Location 2
        • Principal Investigator:
          • Jennifer Ornelas
    • Connecticut
      • Farmington, Connecticut, United States, 06030-2840
        • Recruiting
        • UConn Health
        • Principal Investigator:
          • Jun Lu
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Solutions Through Advanced Research
        • Principal Investigator:
          • Pearl Kwong
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Forcare Clinical Research
        • Contact:
          • Phone Number: 8132642155
        • Principal Investigator:
          • Seth Benjamin Forman
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Treasure Valley Medical Research
        • Contact:
          • Phone Number: 208-813-6505
        • Principal Investigator:
          • Elizabeth Swanson
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
          • Phone Number: 312-695-3721
        • Principal Investigator:
          • Amy Paller
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Recruiting
        • Allergy and Asthma Specialist
        • Principal Investigator:
          • Lee S. Clore
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Phone Number: 804-301-9948
        • Principal Investigator:
          • JiaDe Yu
    • Michigan
      • Auburn Hills, Michigan, United States, 48326
        • Recruiting
        • Oakland Hills Dermatology
        • Contact:
          • Phone Number: 248-858-2255
        • Principal Investigator:
          • Christofer Buatti
      • Bay City, Michigan, United States, 48706
        • Recruiting
        • Great Lakes Research Group, Inc.
        • Contact:
          • Phone Number: 989-895-9100
        • Principal Investigator:
          • Brent Boyce
      • Caledonia, Michigan, United States, 49316
        • Recruiting
        • The Derm Institute of West Michigan
        • Contact:
          • Phone Number: 616-326-0114
        • Principal Investigator:
          • Kristi Hawley
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Respiratory Medicine Research Institute of Michigan, PLC
        • Contact:
          • Phone Number: 734-528-0477
        • Principal Investigator:
          • Jeffrey G. Leflein
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Recruiting
        • Dartmouth-Hitchcock Medical Center
        • Principal Investigator:
          • Brian Simmons
    • Ohio
      • Fairborn, Ohio, United States, 45324
        • Recruiting
        • Wright State Physicians
        • Contact:
          • Phone Number: 937-245-7500
        • Principal Investigator:
          • Craig Rohan
    • Pennsylvania
      • Exton, Pennsylvania, United States, 19341
        • Recruiting
        • The Pennsylvania Centre for Dermatology, LLC
        • Contact:
          • Phone Number: 610-594-6660
        • Principal Investigator:
          • Scott Gottlieb
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Phone Number: 843-792-9784
        • Principal Investigator:
          • Lara Wine Lee
    • Texas
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
          • Phone Number: 713-500-8266
        • Principal Investigator:
          • Adelaide Hebert
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Kristen Holland

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

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 s if participants are ≥6 years of age, and

  • 6 months if participants are 6 months to <6 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
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
Topical corticosteroid
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
Topical corticosteroid
Placebo Comparator: Placebo
Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
Drug: Topical corticosteroid
Topical corticosteroid
Drug: Placebo
Placebo given SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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
Baseline to Week 16

Secondary Outcome Measures

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
Percentage of Participants with a Pruritus NRS Score of ≥4 points at Baseline Who Achieve Both EASI-75 and a ≥4-point Reduction in Pruritus NRS Score from Baseline
Time Frame: Baseline to Week 1
Baseline to Week 1
Mean Change from Baseline in Parent-Reported Itch Severity Measure (PRISM)
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
Percentage of Participants with Positive Responses by the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)
Time Frame: Week 14
Week 14

Collaborators and Investigators

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

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 9 AM - 5 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)

October 18, 2022

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

June 15, 2025

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)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

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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