#1 Clinical Trials Search in Europe

Agents For Dermatitis, Excluding Corticosteroids

This article discusses a clinical trial investigating the use of agents for dermatitis (excluding corticosteroids) in children and teenagers with moderate to severe atopic dermatitis, also known as eczema. The study focuses on a drug called lebrikizumab, which is being tested in combination with topical corticosteroids to assess its efficacy and safety in treating this skin condition.

Table of Contents

What is this Treatment?

A new treatment for atopic dermatitis, also known as eczema, is being studied for children and teenagers. This treatment falls under the category of “Agents for Dermatitis, Excluding Corticosteroids.”[1] The specific drug being tested is called lebrikizumab (LY3650150).

Atopic dermatitis is a chronic skin condition that causes itchy, inflamed skin. It’s common in children but can affect people of all ages. This new treatment offers an alternative to corticosteroids, which are commonly used but can have side effects with long-term use.

How Does it Work?

While the exact mechanism isn’t specified in the trial information, agents for dermatitis that exclude corticosteroids often work by targeting specific parts of the immune system that are involved in causing inflammation in the skin. Lebrikizumab, the drug being studied, likely works in this way to reduce the symptoms of atopic dermatitis.[1]

Who Can Use This Treatment?

This treatment is being studied for use in children and teenagers with moderate-to-severe atopic dermatitis. The study includes participants from 6 months to less than 18 years of age.[1]

Eligibility Criteria

To be eligible for the study, participants must meet several criteria:

  • Have had atopic dermatitis for at least 6 months (if younger than 6 years old) or 1 year (if older than 6 years)[1]
  • Be between 6 months and 6 years old and weigh over 6 kilograms, or be between 12 and 18 years old and weigh less than 40 kilograms[1]
  • Have a parent or legal guardian who can provide consent and follow study guidelines[1]

Who Should Not Use This Treatment?

Some people may not be eligible for this treatment. Exclusion criteria include:

  • Recent participation in a similar study or use of certain forbidden treatments[1]
  • Pregnancy or breastfeeding[1]
  • Previous allergic reactions to the study drug or related substances[1]
  • Severe or current infections requiring strong antibiotics[1]
  • Certain medical conditions that could affect safety[1]
  • Drug or alcohol addiction[1]

How Effective is the Treatment?

The effectiveness of this treatment is being measured in two main ways:

  1. The percentage of participants who achieve an Investigator Global Assessment (IGA) score of 0 or 1 and a reduction of at least 2 points from their baseline score. An IGA score is a way for doctors to measure the severity of atopic dermatitis.[1]
  2. The percentage of participants who achieve at least a 75% reduction in their Eczema Area and Severity Index (EASI) score. The EASI score is another tool used to measure the extent and severity of atopic dermatitis.[1]

These measurements will help determine how well the treatment works in reducing the symptoms and severity of atopic dermatitis in children and teenagers.

How is the Treatment Administered?

The treatment is administered topically, which means it’s applied directly to the skin.[1] The study mentions that it’s used in combination with topical corticosteroids (TCS), suggesting that patients may use both this new treatment and traditional corticosteroid creams or ointments as part of their treatment plan.

The maximum daily dose is 1 unit (the specific unit is not specified), and the maximum total dose over the course of treatment is 126 units. The maximum treatment period is 18 weeks.[1]

Aspect Details
Study Type Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study
Drug Studied Lebrikizumab (LY3650150)
Condition Moderate to Severe Atopic Dermatitis
Age Group 6 months to <18 years
Treatment Combination Lebrikizumab with Topical Corticosteroids
Primary Endpoints 1. IGA score 0 or 1 with ≥2 point reduction
2. EASI-75 (≥75% reduction in EASI score)
Maximum Treatment Duration 18 weeks
Drug Category Agents for Dermatitis, Excluding Corticosteroids
Administration Route Topical

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the effectiveness of lebrikizumab when used together with topical corticosteroid treatment, compared to a placebo, in children and teenagers with moderate to severe atopic dermatitis.
  • Who can participate in this study? Participants must be between 6 months and 18 years old, have had atopic dermatitis for at least 6 months (if younger than 6 years) or 1 year (if older than 6 years), and meet specific weight requirements. Additionally, a parent or legal guardian must be able to provide consent and follow study guidelines.
  • What are the main criteria for exclusion from the study? Participants may be excluded if they have recently been in a similar study, received certain treatments in the past 2-8 weeks, are pregnant or breastfeeding, have had previous reactions to the study drug or related products, have severe infections, have certain medical conditions, or have addiction issues.
  • How will the effectiveness of the treatment be measured? The study will measure effectiveness using two primary methods: 1) The percentage of participants achieving a certain score on the Investigator Global Assessment (IGA) scale, and 2) The percentage of participants achieving at least a 75% reduction in their Eczema Area and Severity Index (EASI) score.
  • What is the duration of the treatment in this study? The maximum treatment period for this study is 18 weeks, during which participants will receive either lebrikizumab or a placebo in combination with topical corticosteroids.

Ongoing Clinical Trials on Agents For Dermatitis, Excluding Corticosteroids

  • Study of Lebrikizumab and Topical Corticosteroids for Children and Teens with Moderate-to-Severe Atopic Dermatitis

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Poland Spain

Glossary

  • Atopic Dermatitis: A chronic skin condition characterized by itchy, inflamed skin. It is also known as eczema and is more common in children but can occur at any age.
  • Lebrikizumab: An investigational drug being studied for the treatment of moderate to severe atopic dermatitis in combination with topical corticosteroids.
  • Topical Corticosteroids: Steroid medications applied directly to the skin to reduce inflammation and itching associated with various skin conditions, including atopic dermatitis.
  • Placebo: A substance with no active medical properties, used as a control in testing new drugs to evaluate their effectiveness.
  • Investigator Global Assessment (IGA): A tool used by researchers to evaluate the overall severity of a skin condition, typically on a scale from 0 (clear) to 4 (severe).
  • Eczema Area and Severity Index (EASI): A standardized method for measuring the extent and severity of atopic dermatitis, taking into account factors such as the area affected and the intensity of symptoms.
  • Phase 3 Study: A large-scale clinical trial designed to confirm the safety and efficacy of a new treatment before it can be approved for widespread use.

References

  1. http://clinicaltrials.eu/trial/study-of-lebrikizumab-and-topical-corticosteroids-for-children-and-teens-with-moderate-to-severe-atopic-dermatitis/