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Clinical Trials in Germany / NCT05559359
Active, not recruiting Phase 3

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

NCT05559359 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2022-10-18
Last updated
2026-07-30

Condition(s) studied

Atopic DermatitisEczema

Investigational drug(s) / intervention(s)

Lebrikizumab →PlaceboTopical Corticosteroid (TCS)

Lebrikizumab: Administered SC

Placebo: Placebo given SC

Topical Corticosteroid (TCS): TCS administered

Study 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).

Eligibility

Sex
ALL
Min age
6 Months
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (85)

FacilityCityRegionStatus
Clinical Research Center of Alabama Birmingham Alabama
Phoenix Children's Hospital Phoenix Arizona
Arkansas Research Trials North Little Rock Arkansas
First OC Dermatology Fountain Valley California
Antelope Valley Clinical Trials Lancaster California
Dermatology Research Associates Los Angeles California
Integrative Skin Science and Research Sacramento California
Rady's Children Hospital San Diego - Dermatology San Diego California
UConn Health Farmington Connecticut
Solutions Through Advanced Research Jacksonville Florida
ForCare Clinical Research Tampa Florida
Treasure Valley Medical Research Boise Idaho
Northwestern University Chicago Illinois
Allergy & Asthma Specialists, P.S.C. Owensboro Kentucky
Respiratory Medicine Research Institute of Michigan, PLC Ypsilanti Michigan
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey
Dermatologists of Central States, LLC Fairborn Ohio
Medical University of South Carolina Charleston South Carolina
Texas Dermatology and Laser Specialists San Antonio Texas
Medical College of Wisconsin Milwaukee Wisconsin
CONEXA Investigacion Clinica S.A. Buenos Aires Argentina
Instituto de Neumonología Y Dermatología Buenos Aires Argentina
Derma Internacional Buenos Aires Argentina
Psoriahue Buenos Aires Argentina
Fundación Respirar Buenos Aires Argentina
Fundacion Estudios Clinicos Rosario Argentina
Cornerstone Dermatology Coorparoo Australia
Sydney Children's Hospital Randwick Australia
The Children's Hospital at Westmead Westmead Australia
Veracity Clinical Research Woolloongabba Australia
Fundação Pio XII - Hospital de Câncer de Barretos Barretos Brazil
Centro de Pesquisa Sao Lucas Campinas Brazil
Hospital de Clinicas de Porto Alegre Porto Alegre Brazil
Hospital de Clínicas de Ribeirão Preto Ribeirão Preto Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica Rio de Janeiro Brazil
Faculdade de Medicina do ABC Santo André Brazil
Clinica de Alergia Martti Antila Sorocaba Brazil
Dermatology Research Institute Calgary Canada
DermEdge Research Mississauga Canada

+ 45 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05559359 on ClinicalTrials.gov ↗ ← All trials in Germany