Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
18265 Enrolling

Child-Adolescent Atopic Dermatitis Research Trial (28 Weeks)


Treatment: Injection Age: 6 Months


Children from 6 months to less than 12 years of age, and adolescents from 12 to less than 18 years of age with a diagnosis of atopic dermatitis (eczema) may qualify for a clinical research trial. Selected subjects must have moderate to severe eczema presenting on 10% or more of body surface area (BSA). History of inadequate response to treatment with topical medications is also required for this study.

Participants will receive investigational medication  (active study drug) or placebo via injection.  Study medication and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses may be provided.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Mark Lomaga

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: September 24, 2023

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

ClinicalTrials.gov ID

NCT05559359

Sponsor

Eli Lilly and Company

Study Description

  • Brief Summary:

    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).

  • Condition or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Drug: Lebrikizumab
    Drug: Lebrikizumab
    Drug: Placebo
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    6 Months and 17 Years (Child)

  • Sexes Eligible for Study:

    All

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.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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