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Other Immunosuppressants

This article discusses a clinical trial investigating the use of other immunosuppressants, specifically lebrikizumab, in treating moderate-to-severe atopic dermatitis (eczema) in children and teenagers. The study aims to evaluate the effectiveness and safety of this medication when used alongside topical corticosteroids in patients aged 6 months to under 18 years.

Table of Contents

What are OTHER IMMUNOSUPPRESSANTS?

OTHER IMMUNOSUPPRESSANTS is a category of medications used to suppress or reduce the strength of the body’s immune system. These drugs are classified under the ATC code L04AX, which stands for “Other Immunosuppressants” in the Anatomical Therapeutic Chemical (ATC) classification system.[1] This category includes various medications that don’t fit into more specific immunosuppressant categories.

Medical Conditions Treated

Based on the clinical trial information provided, OTHER IMMUNOSUPPRESSANTS are being studied for the treatment of Atopic Dermatitis, also known as Eczema.[1] Atopic dermatitis is a chronic inflammatory skin condition characterized by itchy, red, and swollen skin. It often begins in childhood and can persist into adulthood.

How They Work

OTHER IMMUNOSUPPRESSANTS work by modulating the immune system’s response. In the case of atopic dermatitis, these medications may help reduce inflammation and alleviate symptoms by suppressing overactive immune responses that contribute to skin irritation and itching.[1]

Administration and Dosage

According to the clinical trial data, OTHER IMMUNOSUPPRESSANTS in this study are administered orally.[1] The maximum daily dose is 20 mg, with a maximum total dose of 240 mg over a treatment period of up to 12 weeks. However, it’s important to note that these dosages are specific to the clinical trial and may not reflect the final approved dosages for general use.

Eligibility for Treatment

The clinical trial for OTHER IMMUNOSUPPRESSANTS in treating atopic dermatitis has specific eligibility criteria. These include:

  • Having atopic dermatitis for at least 6 months (if younger than 6 years old) or 1 year (if older than 6 years)[1]
  • Being between 6 months and 18 years old, with specific weight requirements[1]
  • Having moderate-to-severe atopic dermatitis[1]

Exclusion criteria include:

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

Clinical Trial Information

The clinical trial (2022-501476-25-00) is a Phase 3 study evaluating the efficacy, safety, and pharmacokinetics of lebrikizumab (an OTHER IMMUNOSUPPRESSANT) compared to placebo in children and adolescents with moderate-to-severe atopic dermatitis.[1] The study aims to assess the effectiveness of lebrikizumab when used in combination with topical corticosteroids (TCS).

The main objectives of the trial include:

  1. Evaluating the percentage of participants achieving an Investigator Global Assessment (IGA) score of 0 or 1 and a reduction of ≥2 points from baseline[1]
  2. Assessing the percentage of participants achieving a 75% or greater reduction in the Eczema Area and Severity Index (EASI-75) score from baseline[1]

Potential Side Effects

As with all medications, OTHER IMMUNOSUPPRESSANTS may have potential side effects. While specific side effects are not detailed in the provided clinical trial information, common side effects of immunosuppressants can include:

  • Increased risk of infections
  • Nausea or gastrointestinal issues
  • Fatigue
  • Headaches
  • Changes in blood pressure

It’s important to discuss potential side effects with your healthcare provider before starting any new medication.

Aspect Details
Study Type Randomized, Double-Blind, Placebo-Controlled, Phase 3
Condition Moderate-to-Severe Atopic Dermatitis
Age Range 6 months to <18 years
Treatment Lebrikizumab + Topical Corticosteroids
Control Placebo
Primary Endpoints IGA score improvement, EASI-75 achievement
Max Daily Dose 20 mg
Max Total Dose 240 mg
Treatment Duration Up to 12 weeks

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this trial is to evaluate the effectiveness of lebrikizumab, an immunosuppressant, 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 criteria. They must also have a parent or legal guardian able to provide consent and follow study guidelines.
  • What are some reasons someone might not be able to participate? Exclusion criteria include recent participation in similar studies, pregnancy or breastfeeding, previous adverse reactions to the study drug or related treatments, severe infections, certain medical histories, and drug or alcohol addiction.
  • How will the effectiveness of the treatment be measured? The study will measure effectiveness using two primary endpoints: the percentage of participants achieving an Investigator Global Assessment (IGA) score of 0 or 1 with a reduction of at least 2 points from baseline, and the percentage of participants achieving at least a 75% reduction in their Eczema Area and Severity Index (EASI) score.
  • What is the maximum dose and treatment duration in this study? The maximum daily dose of the immunosuppressant is 20 mg, with a maximum total dose of 240 mg. The maximum treatment period is 12 weeks.

Ongoing Clinical Trials on Other Immunosuppressants

  • 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 inflammatory skin condition characterized by itchy, red, and dry skin. It is also known as eczema.
  • Lebrikizumab: An investigational immunosuppressant drug being studied for the treatment of moderate-to-severe atopic dermatitis.
  • Topical Corticosteroids: Steroid medications applied directly to the skin to reduce inflammation and relieve itching.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • Investigator Global Assessment (IGA): A tool used by researchers to evaluate the overall severity of a skin condition.
  • Eczema Area and Severity Index (EASI): A standardized method for measuring the extent and severity of atopic dermatitis.
  • Phase 3 Study: A large-scale clinical trial to confirm the effectiveness and monitor side effects of a new drug or treatment.
  • Immunosuppressant: A type of medication that reduces the activity of the immune system.
  • Efficacy: The ability of a treatment to produce the desired result.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.

References

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