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

NCT05559359

Active Not RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Atopic Dermatitis, Eczema

Interventions: Lebrikizumab, Placebo, Topical Corticosteroid (TCS)

Countries: United States, Argentina, Australia, Brazil, Canada, Czechia, Germany, Japan

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 overview

Sex: ALL

Age: 6 Months to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (85)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • North Little Rock, Arkansas, United States
  • Fountain Valley, California, United States
  • Lancaster, California, United States
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • Farmington, Connecticut, United States
  • Jacksonville, Florida, United States
  • Tampa, Florida, United States
  • Boise, Idaho, United States
  • Chicago, Illinois, United States
  • Owensboro, Kentucky, United States
  • Ypsilanti, Michigan, United States
  • Lebanon, New Hampshire, United States
  • East Windsor, New Jersey, United States
  • Fairborn, Ohio, United States
  • Charleston, South Carolina, United States
  • San Antonio, Texas, United States
  • Milwaukee, Wisconsin, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Rosario, Argentina
  • Coorparoo, Australia
  • Randwick, Australia
  • Westmead, Australia
  • + 55 more on CT.gov