A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-1)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Atopic Dermatitis; Eczema

Treatments: Drug: Placebo; Drug: Lebrikizumab; Drug: Topical corticosteroid

Study type: Interventional

Funder types: Industry

Identifiers

NCT05559359

2022-501476-25-00 (Other Identifier)

2021-005232-29 (EudraCT Number)

DRM06-AD13 (Other Identifier)

18265

J2T-MC-KGBI (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 300 estimated patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

Lebrikizumab (Cohort 1)

Experimental group

Description:

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.

Treatment:

Drug: Topical corticosteroid

Drug: Lebrikizumab

Lebrikizumab (Cohort 2)

Experimental group

Description:

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.

Treatment:

Drug: Topical corticosteroid

Drug: Lebrikizumab

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matching lebrikizumab by SC injections with a TCS.

Treatment:

Drug: Topical corticosteroid

Drug: Placebo