Image

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

Recruiting
6 - 17 years of age
Both
Phase 3

Powered by AI

Overview

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).

Eligibility

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.

Study details

Atopic Dermatitis, Eczema

NCT05559359

Eli Lilly and Company

26 June 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.