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

JRCT ID: jRCT2031220533

Registered date:23/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis, Eczema
• Date of first enrollment: 04/03/2023
• Target sample size: 300
• Countries of recruitment: Argentina,Japan,Australia,Japan,Canada,Japan,Czechia,Japan,France,Japan,Germany,Japan,Mexico,Japan,Poland,Japan,Spain,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

-Drug: Lebrikizumab
Administered SC
Other Names:
LY3650150
DRM06
-Drug: Placebo
Placebo given SC
-Drug: Topical corticosteroid
Topical corticosteroid

[Study Arms]
-Experimental: Lebrikizumab (Cohort 1)
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.
Interventions:
Drug: Lebrikizumab
Drug: Topical corticosteroid
-Experimental: Lebrikizumab (Cohort 2)
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.
Interventions:
Drug: Lebrikizumab
Drug: Topical corticosteroid
-Placebo Comparator: Placebo
Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
Interventions:
Drug: Placebo
Drug: Topical corticosteroid

Outcome(s)

Primary Outcome

-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 ]

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: <= 17age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05559359