Print

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.