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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis, Eczema

In brief

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).

Key facts

Study ID

NCT05559359

Run by

Eli Lilly and Company

People needed

377

Starts

2022-10-18

Expected to finish

2026-12-01

Last updated by the study team

2026-07-30

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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,
• 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.

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.

Where it is running

• Psoriahue — Buenos Aires, Argentina
• Fundación Respirar — Buenos Aires, Argentina
• Clinical Research Center of Alabama — Birmingham, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Arkansas Research Trials — North Little Rock, Arkansas, United States
• First OC Dermatology — Fountain Valley, California, United States
• Antelope Valley Clinical Trials — Lancaster, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Integrative Skin Science and Research — Sacramento, California, United States
• Rady's Children Hospital San Diego - Dermatology — San Diego, California, United States
• UConn Health — Farmington, Connecticut, United States
• Solutions Through Advanced Research — Jacksonville, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• Allergy & Asthma Specialists, P.S.C. — Owensboro, Kentucky, United States
• Respiratory Medicine Research Institute of Michigan, PLC — Ypsilanti, Michigan, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States
• Dermatologists of Central States, LLC — Fairborn, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Dermatology and Laser Specialists — San Antonio, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• CONEXA Investigacion Clinica S.A. — Buenos Aires, Argentina
• Derma Internacional — Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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