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

Atopic Dermatitis | Eczema

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).

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    1 to 17

Critères de participation

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.

Lieu de l'étude

DermEdge Research
DermEdge Research
Mississauga, Ontario
Canada

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Alberta Dermasurgery Centre
Alberta Dermasurgery Centre
Edmonton, Alberta
Canada

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Dermatology Research Institute
Dermatology Research Institute
Calgary, Alberta
Canada

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Étude parrainée par
Eli Lilly and Company
Participants recherchés
Plus d'informations
ID de l'étude: NCT05559359