The trial is taking place at:
F

ForCare Clinical Research | Tampa, FL

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

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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

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

Trial contacts and locations

99

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559)

Data sourced from clinicaltrials.gov

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