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

NCT05559359 | Active Not Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: 18265J2T-MC-KGBIDRM06-AD132021-005232-292022-501476-25-00
• Study Type: interventional
• Target: 367
• Locations: 12 countries
• Sites: 85

Brief 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).

Conditions

Atopic Dermatitis; Eczema

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

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

  Baseline to 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

• 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 Change from Baseline in EASI Score

  Baseline, Week 16

• Percentage Change from Baseline in Pruritus NRS Score

  Baseline, Week 16

Study Arms (3)

Lebrikizumab (Cohort 1)

EXPERIMENTAL

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; Drug: Topical Corticosteroid (TCS)

Lebrikizumab (Cohort 2)

EXPERIMENTAL

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; Drug: Topical Corticosteroid (TCS)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matching lebrikizumab by SC injections with a TCS.

Drug: Placebo; Drug: Topical Corticosteroid (TCS)

Interventions

Lebrikizumab DRUG

Administered SC

Also known as: LY3650150, DRM06

Lebrikizumab (Cohort 1); Lebrikizumab (Cohort 2)

Placebo DRUG

Placebo given SC

Placebo

Topical Corticosteroid (TCS) DRUG

TCS administered

Lebrikizumab (Cohort 1); Lebrikizumab (Cohort 2); Placebo

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least,
• months if participants are ≥6 years of age
• months if participants are 2 to \<6 years of age
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Dermira, Inc.: collaborator

Study Sites (85)

Clinical Research Center of Alabama

Birmingham, Alabama, 35209, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Arkansas Research Trials

North Little Rock, Arkansas, 72217, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Antelope Valley Clinical Trials

Lancaster, California, 93534, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Rady's Children Hospital San Diego - Dermatology

San Diego, California, 92123, United States

Location

UConn Health

Farmington, Connecticut, 06030-2840, United States

Location

Solutions Through Advanced Research

Jacksonville, Florida, 32256, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky, 42301, United States

Location

Respiratory Medicine Research Institute of Michigan, PLC

Ypsilanti, Michigan, 48197, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Dermatologists of Central States, LLC

Fairborn, Ohio, 45324, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

CONEXA Investigacion Clinica S.A.

Buenos Aires, 1012, Argentina

Location

Instituto de Neumonología Y Dermatología

Buenos Aires, 1425, Argentina

Location

Derma Internacional

Buenos Aires, 1426, Argentina

Location

Psoriahue

Buenos Aires, C1425DKG, Argentina

Location

Fundación Respirar

Buenos Aires, C1426ABP, Argentina

Location

Fundacion Estudios Clinicos

Rosario, S2000DEJ, Argentina

Location

Cornerstone Dermatology

Coorparoo, 4151, Australia

Location

Sydney Children's Hospital

Randwick, 2031, Australia

Location

The Children's Hospital at Westmead

Westmead, 2145, Australia

Location

Veracity Clinical Research

Woolloongabba, 4102, Australia

Location

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, 14784400, Brazil

Location

Centro de Pesquisa Sao Lucas

Campinas, 13060-803, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, 90035-903, Brazil

Location

Hospital de Clínicas de Ribeirão Preto

Ribeirão Preto, 14051-140, Brazil

Location

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, 20241-180, Brazil

Location

Faculdade de Medicina do ABC

Santo André, 09060-870, Brazil

Location

Clinica de Alergia Martti Antila

Sorocaba, 18040-425, Brazil

Location

Dermatology Research Institute

Calgary, T2J 7E1, Canada

Location

DermEdge Research

Mississauga, L4Y 4C5, Canada

Location

Fakultni nemocnice Bulovka

Prague, 180 81, Czechia

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

Rosenpark Research GmbH

Darmstadt, 64283, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Asahikawa Medical University Hospital

Asahikawa, 078-8510, Japan

Location

Fukuyama City Hospital

Fukuyama, 721-8511, Japan

Location

Osaka Habikino Medical Center

Habikino, 583-8588, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Ina Central Hospital

Ina, 396-0033, Japan

Location

Enomoto Clinic

Kumagaya, 360-0018, Japan

Location

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Okayama City General Medical Center Okayama City Hospital

Okayama, 700-8557, Japan

Location

National Hospital Organization Sagamihara National Hospital

Sagamihara, 252-0392, Japan

Location

Dermatology and Ophthalmology Kume Clinic

Sakai, 593-8324, Japan

Location

Sugamo Sengoku Dermatology

Toshima City, 170-0002, Japan

Location

Fujita Health University

Toyoake, 470-1192, Japan

Location

Scientia Investigacion Clinica S.C.

Chihuahua City, 31207, Mexico

Location

PanAmerican Clinical Research - Cuernavaca

Cuernavaca, 62290, Mexico

Location

Hospital de Jesús Nazareno

Mexico City, 06090, Mexico

Location

Trials in Medicine

Mexico City, 06700, Mexico

Location

Hospital Infantil de Mexico Federico Gomez

Mexico City, 06720, Mexico

Location

Eukarya PharmaSite

Monterrey, 64718, Mexico

Location

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, 66460, Mexico

Location

Arké SMO S.A de C.V

Veracruz, 91900, Mexico

Location

Instituto Dermatologico de Jalisco

Zapopan, 45190, Mexico

Location

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

Gdansk, 80-546, Poland

Location

Diamond Clinic

Krakow, 31-559, Poland

Location

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

Lodz, 90-265, Poland

Location

Centrum Medyczne Evimed

Warsaw, 02-625, Poland

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, 08950, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrín

Las, 35010, Spain

Location

Grupo Pedro Jaén

Madrid, 28006, Spain

Location

Hospital Infantil Universitario Niño Jesús

Madrid, 28009, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

National Taiwan University Hospital - Hsinchu branch

Hsinchu, 300, Taiwan

Location

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, 83301, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Chang Gung Memorial Hospital-Taipei

Taipei, 105, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

Location

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

lebrikizumab; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: October 18, 2022
• Primary Completion: January 14, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

PL (4); CZ (1); JP (12); BR (7); AR (6); TW (7); AU (4); DE (5); ME (9); CA (2); US (21); ES (7)