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

Purpose

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).

Conditions

  • Atopic Dermatitis
  • Eczema

Eligibility

Eligible Ages
Between 6 Months and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 s if participants are ≥6 years of age, and - 6 months if participants are 6 months to <6 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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lebrikizumab (Cohort 1) 		Participants who are 6 years to <18 years of age, 12 years to <18 years of age who weigh <40 kilogram (kg) or 6 years to <12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS). Dosing will be based on weight.
  • Drug: Lebrikizumab
    Administered SC
    Other names:
    • LY3650150
    • DRM06
  • Drug: Topical corticosteroid
    Topical corticosteroid
Experimental
Lebrikizumab (Cohort 2) 		Participants who are 6 months to <6 years of age, 2 years to <6 years of age or 6 months to <2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS. Dosing will be based on weight.
  • Drug: Lebrikizumab
    Administered SC
    Other names:
    • LY3650150
    • DRM06
  • Drug: Topical corticosteroid
    Topical corticosteroid
Placebo Comparator
Placebo 		Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
  • Drug: Placebo
    Placebo given SC
  • Drug: Topical corticosteroid
    Topical corticosteroid

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
804-301-9948

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559)
1-317-615-4559
ClinicalTrials.gov@lilly.com