A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis | EczemaThe 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).
null
Participation Requirements
-
Sex:
ALL -
Eligible Ages:
1 to 17
Participation 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.
Study Location
DermEdge Research
DermEdge ResearchMississauga, Ontario
Canada
Contact Study Team
Alberta Dermasurgery Centre
Alberta Dermasurgery CentreEdmonton, Alberta
Canada
Contact Study Team
Dermatology Research Institute
Dermatology Research InstituteCalgary, Alberta
Canada
Contact Study Team
- Study Sponsored By
- Eli Lilly and Company
- Participants Required
- More Information
- Study ID:
NCT05559359