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

Phase 3

Recruiting

• Conditions: Atopic Dermatitis; Eczema
• Interventions: Drug: Lebrikizumab; Drug: Placebo; Drug: Topical Corticosteroid (TCS)

• Registration Number: NCT05559359
• Lead Sponsor: Eli Lilly and Company

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Study Start: 2022-10-18
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-08
• Last Update Posted: 2025-10-09
• Primary Completion: 2025-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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 if participants are ≥6 years of age
  • 6 months if participants are 2 to <6 years of age
  • 3 months if participants are 6 months to <2 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lebrikizumab (Cohort 1)	Lebrikizumab	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.
Lebrikizumab (Cohort 1)	Topical Corticosteroid (TCS)	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.
Lebrikizumab (Cohort 2)	Lebrikizumab	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.
Lebrikizumab (Cohort 2)	Topical Corticosteroid (TCS)	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.
Placebo	Placebo	Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
Placebo	Topical Corticosteroid (TCS)	Participants will receive placebo matching lebrikizumab by SC injections with a TCS.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score	Baseline to Week 16	IGA is a co-primary endpoint with EASI-75.
Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline	Baseline to Week 16	EASI-75 is a co-primary endpoint with IGA.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score	Baseline to Week 16
Percentage Change from Baseline in EASI Score	Baseline, Week 16
Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline	Baseline to Week 16
Change from Baseline in Children Dermatology Life Quality Index (cDLQI)	Baseline, Week 16
Change from Baseline in Body Surface Area (BSA)	Baseline, Week 16
Percentage of Participants with Positive Responses by the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)	Week 14
Percentage of Participants with a Pruritus NRS Score of ≥4 points at Baseline Who Achieve Both EASI-75 and a ≥4-point Reduction in Pruritus NRS Score from Baseline	Baseline to Week 16
Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS)	Baseline, Week 16
Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD)	Baseline, Week 16
Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score	Baseline to Week 16
Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration	Week 14
Percentage Change from Baseline in Pruritus NRS Score	Baseline, Week 16

Trial Locations

Locations (86)

Asahikawa Medical University Hospital; 🇯🇵 Asahikawa, Japan

Clinical Research Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Arkansas Research Trials; 🇺🇸 North Little Rock, Arkansas, United States

First OC Dermatology; 🇺🇸 Fountain Valley, California, United States

Antelope Valley Clinical Trials; 🇺🇸 Lancaster, California, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Integrative Skin Science and Research - Location 2; 🇺🇸 Sacramento, California, United States

Rady's Children Hospital San Diego - Dermatology; 🇺🇸 San Diego, California, United States

UConn Health; 🇺🇸 Farmington, Connecticut, United States

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