Study of lebrikizumab (LY3650150) in participants aged 6 months to under 18 years with moderate-to-severe atopic dermatitis (ADorable-1)
Topic / Pathology
- interventional
- Paediatric
- Biologic
Objectives
Randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy, safety and pharmacokinetics of lebrikizumab versus placebo in participants aged 6 months to less than 18 years with moderate-to-severe atopic dermatitis.
3 treatment arms: Parallel groups may receive lebrikizumab at 2 different doses or placebo and each arm will also receive topical corticosteroids
https://clinicaltrials.gov/study/NCT05559359?term=%20NCT05559359&rank=1
Sponsor
Lilly
Investigator
Dr Juliette Mazereeuw-Hautier
Critères d'inclusion
- Diagnosed with AD prior to screening, according to the criteria of the American Academy of Dermatology for at least:
- 12 months if participants aged ≥ 6 years, and 6 months if participants aged 6 months to <6 years.
- EASI ≥16, IGA ≥3 and BSA ≥ 10% at screening and inclusion.
Critères de non-inclusion
- Patients who have received an investigational drug within 8 weeks or less than 5 half-lives.
- Patients having received dupilumab within 8 weeks (recruitment of participants having previously used dupilumab will be limited to <20%).
- Treatment with an investigational topical within 2 weeks prior to baseline.
- Vaccination or Bacillus Calmette-Guerin treatment within 4 weeks prior to randomization.
Status
Ongoing
