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

• Status: Not yet recruiting
• Trial end date: 2025-07-15
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Dermira, Inc.

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 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.