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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Months - 17 Years
Gender	All

More Inclusion & Exclusion 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 <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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05559359
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Eli Lilly and Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator Affiliation	Eli Lilly and Company
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Canada, Czechia, France, Germany, Japan, Mexico, Poland, Spain, Taiwan, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Atopic Dermatitis, Eczema
Study Website:	View Trial Website

Arms & Interventions

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.

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.

Placebo Comparator: Placebo

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

Interventions

Drug: - Lebrikizumab

Administered SC

Drug: - Placebo

Placebo given SC

Drug: - Topical corticosteroid

Topical corticosteroid

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Research Center of Alabama, Birmingham, Alabama

Status

Recruiting

Address

Clinical Research Center of Alabama

Birmingham, Alabama, 35209

Site Contact

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