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

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis - J2T-MC-KGBI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220533

Enrollment

300

Registered

2022-12-23

Start date

2023-03-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Eczema

Interventions

-Drug: Lebrikizumab Administered SC Other Names: LY3650150 DRM06 -Drug: Placebo Placebo given SC -Drug: Topical corticosteroid Topical corticosteroid [Study Arms] -Experimental: Lebrikizumab (C

Eligibility

Sex/Gender

All

Inclusion 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 =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

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.

Design outcomes

Primary

Measure	Time frame
-Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction >=2 points from Baseline [ Time Frame: Baseline to Week 16 ] -Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) >=75% Reduction from Baseline in EASI Score [ Time Frame: Baseline to Week 16 ]	—

Countries

Argentina, Australia, Canada, Czechia, France, Germany, Japan, Mexico, Poland, Spain, Taiwan, United States

Contacts

Public ContactTrial Guide Call Center

Eli Lilly Japan K.K.

LTG_CallCenter@lists.lilly.com+81-120-023-812

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026