Dermatitis atopic – Trials in Disease

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Ongoing Clinical Trials for Atopic Dermatitis

There are currently 69 clinical trials investigating new treatments for atopic dermatitis (also known as eczema), conducted across multiple countries in Europe. These studies are testing various medications including oral tablets, injections, and topical creams to help manage moderate to severe forms of this chronic skin condition that causes red, itchy, and inflamed skin.

Clinical trial locations

Effectiveness and Safety of Abrocitinib in Children 6 to Under 12 Years with Moderate-to-Severe Atopic Dermatitis

This trial is studying a medication called abrocitinib for children aged 6 to under 12 years who have moderate-to-severe atopic dermatitis. The study aims to understand how well this oral medication works and whether it is safe for young patients.

Main inclusion criteria: Participants must be between 6 and 12 years old, weigh at least 15 kg (about 33 pounds), and have been diagnosed with moderate-to-severe atopic dermatitis for at least one year. The condition should affect at least 10% of the body surface area, and participants must have an EASI score of 16 or higher, indicating significant disease severity. Previous treatment with topical medications should not have provided adequate improvement for at least 4 weeks.

Main exclusion criteria: Children who have previously failed treatment with a JAK inhibitor cannot participate. Those with active infections requiring treatment, a history of cancer in the past 5 years (with certain exceptions), or major cardiovascular problems within the last 6 months are also excluded. Additionally, pregnant or breastfeeding participants cannot join the study.

Trial focus: The trial evaluates the effectiveness of abrocitinib in reducing eczema severity, measured by the EASI score and other assessment tools. It also monitors the medication’s safety, tracking any side effects and changes in participants’ overall health. Throughout the 16-week study, researchers will assess improvements in itching, scratching, and the extent of eczema, as well as changes in quality of life.

Investigational drug: Abrocitinib is an oral medication that works by blocking specific enzymes (JAK1) involved in the inflammatory process. This helps reduce inflammation in the skin, potentially decreasing itching, redness, and skin lesions associated with atopic dermatitis. In this trial, it is given alongside regular topical treatments.

Study Comparing Methylprednisolone Aceponate Creams and a Non-Active Cream for Patients with Mild to Moderate Atopic Dermatitis

This study compares the effectiveness and safety of methylprednisolone aceponate creams against a non-active cream (vehicle) for treating mild to moderate atopic dermatitis. The trial is double-blind, meaning neither participants nor researchers know who receives which treatment.

Main inclusion criteria: Participants must be at least 6 years old with a diagnosis of mild to moderate atopic dermatitis, with affected skin covering 10% to 40% of the body. The condition must be confirmed using specific medical assessments at the beginning of the study.

Main exclusion criteria: Patients with severe atopic dermatitis, those with allergies to study cream ingredients, or individuals with other skin conditions that could interfere with results cannot participate. Pregnant or breastfeeding women are also excluded.

Trial focus: The primary goal is to measure the percent change in the EASI score from the start to the end of the 3-week treatment period. Secondary outcomes include achieving clear or almost clear skin condition and improvements in itch severity. The study also tracks the affected body surface area and quality of life assessments.

Investigational drug: Methylprednisolone aceponate is a topical corticosteroid cream that reduces inflammation and relieves symptoms like itching and redness when applied to the skin.

Study Comparing Methylprednisolone Aceponate Ointment and a Drug Combination for Patients with Mild to Moderate Atopic Dermatitis

This trial tests methylprednisolone aceponate ointment compared to Advantan ointment and a vehicle ointment for mild to moderate atopic dermatitis. The study monitors changes in skin condition over a 3-week treatment period.

Main inclusion criteria: Participants must be 6 years or older with mild to moderate atopic dermatitis affecting at least 10% but not more than 40% of body surface area. Initial assessments must confirm adequate severity scores.

Main exclusion criteria: Those with severe atopic dermatitis, recent use of other treatments that could affect results, known allergies to study ingredients, and pregnant or breastfeeding women cannot participate.

Trial focus: The main goal is to evaluate skin condition improvements measured by EASI and IGA scores. The study also assesses itchiness reduction and overall therapeutic success by comparing the test ointment to reference treatments.

Investigational drug: Methylprednisolone aceponate ointment is a corticosteroid applied topically to reduce skin inflammation and suppress immune responses, helping alleviate eczema symptoms.

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

This trial studies lebrikizumab, a monoclonal antibody injection, combined with topical corticosteroids for children and adolescents (6 months to under 18 years) with moderate-to-severe atopic dermatitis. The study compares lebrikizumab to placebo.

Main inclusion criteria: Participants must have atopic dermatitis for at least 6 months (if under 6 years) or 1 year (if over 6 years), weigh over 6 kg if aged 6 months to 6 years or less than 40 kg if aged 12 to 18 years. A parent or legal guardian must provide consent.

Main exclusion criteria: The trial description does not provide specific exclusion criteria in detail.

Trial focus: The study evaluates how well lebrikizumab reduces eczema symptoms and improves skin condition when combined with topical corticosteroids. Researchers monitor the severity of symptoms and track participants’ progress throughout the study period.

Investigational drug: Lebrikizumab works by targeting a specific protein (interleukin-13) involved in the inflammation process, helping reduce symptoms of atopic dermatitis when given as a subcutaneous injection.

Study of Upadacitinib and Topical Corticosteroids for Adolescents and Adults with Moderate to Severe Eczema

This trial tests upadacitinib, a JAK1 inhibitor taken as an oral tablet, combined with topical corticosteroids for adolescents and adults with moderate to severe atopic dermatitis who may need systemic therapy.

Main inclusion criteria: Participants must be aged 12 to 75 years with active moderate to severe atopic dermatitis, measured by specific severity scores (EASI, IGA, BSA, and pruritus). They must be candidates for systemic therapy or have recently needed it, and must be able to tolerate topical corticosteroids.

Main exclusion criteria: Those with severe allergic reactions to study medications, currently participating in another trial, certain types of cancer history, active infections, pregnancy or breastfeeding, certain heart conditions, liver disease, blood disorders, recent vaccines, or drug/alcohol abuse cannot participate.

Trial focus: The primary goal is to determine the proportion of participants achieving significant improvement (vIGA-AD 0/1 and EASI 75) by week 16. The study also tracks improvements in itching and further reductions in EASI scores over time.

Investigational drug: Upadacitinib works by inhibiting JAK enzymes involved in inflammation, helping reduce eczema symptoms when taken orally as a modified-release tablet.

Study on Amlitelimab for Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis Using Topical Corticosteroids and Inadequate Response to Previous Treatments

This trial studies amlitelimab, given as a subcutaneous injection, for participants aged 12 and older with moderate-to-severe atopic dermatitis who have not responded adequately to previous treatments like biologic therapies or JAK inhibitors. Participants continue using topical corticosteroids alongside the study medication.

Main inclusion criteria: Participants must be at least 12 years old, weigh at least 25 kg, and have been diagnosed with atopic dermatitis for at least one year. They must have a documented history of inadequate response to certain treatments. The condition must meet specific severity criteria at baseline.

Main exclusion criteria: Those with severe allergies to study ingredients, other skin conditions that might interfere, certain infections, serious health issues, pregnancy or breastfeeding, recent participation in other trials, or inability to follow procedures are excluded.

Trial focus: The study evaluates the effectiveness of amlitelimab in reducing eczema severity (EASI score) and achieving clear or almost clear skin (vIGA-AD score) after 36 weeks. It also monitors quality of life improvements and safety throughout the trial.

Investigational drug: Amlitelimab is a monoclonal antibody that targets specific immune pathways to reduce inflammation, administered as a subcutaneous injection.

Study on Amlitelimab for Patients Aged 12 and Older with Moderate-to-Severe Atopic Dermatitis

This trial evaluates amlitelimab as monotherapy (used alone) for maintaining treatment response in participants aged 12 and older with moderate-to-severe atopic dermatitis who have already responded to amlitelimab in previous studies. The study tests different dosing schedules (every 4 weeks versus every 12 weeks).

Main inclusion criteria: Participants must be at least 12 years old, weigh at least 25 kg, have completed a previous amlitelimab study without permanently stopping treatment, and be willing to attend study visits and follow procedures.

Main exclusion criteria: Those who have not participated in parent studies, do not have atopic dermatitis, are outside the age range, cannot follow procedures, have certain medical conditions, are pregnant or breastfeeding, take interfering medications, have known allergies, or recently participated in other trials are excluded.

Trial focus: The primary goal is to assess the proportion of participants maintaining clinical response at week 48, comparing different amlitelimab dosing schedules. The study also evaluates long-term safety and effectiveness.

Investigational drug: Amlitelimab is a monoclonal antibody administered subcutaneously that modulates immune responses to reduce inflammation and improve skin condition in atopic dermatitis.

Study on Atopic Dermatitis Treatment with Baricitinib, Tralokinumab, Abrocitinib, Upadacitinib, and Dupilumab for Patients Needing Second-Line Systemic Therapy

This Spanish trial aims to optimize treatment for atopic dermatitis by identifying genetic, biochemical, and immunological markers that predict response to several medications: baricitinib, tralokinumab, abrocitinib, upadacitinib, and dupilumab. The study focuses on patients with moderate to severe atopic dermatitis requiring second-line systemic therapy.

Main inclusion criteria: Participants must have been diagnosed with moderate-severe atopic dermatitis and be either planning to start or already receiving second-line systemic treatment. Both males and females of all ages (children, teenagers, and adults) can participate.

Main exclusion criteria: Those currently participating in other trials or unable to follow study procedures are excluded.

Trial focus: The study tracks participants over 16 weeks, measuring improvements in skin condition using EASI and SCORAD scores. The goal is to develop models predicting treatment outcomes based on individual patient characteristics.

Investigational drugs: The trial tests multiple medications that target different immune pathways: dupilumab (blocking IL-4/IL-13), baricitinib (JAK inhibitor), upadacitinib (JAK inhibitor), tralokinumab (blocking IL-13), and abrocitinib (JAK1 inhibitor).

Study on Long-Term Safety and Efficacy of Amlitelimab for Patients with Moderate to Severe Atopic Dermatitis from Previous Trials

This long-term extension study evaluates the safety and effectiveness of amlitelimab over an extended period for participants who completed previous amlitelimab trials. The trial monitors participants who have already responded to the medication in earlier studies.

Main inclusion criteria: Participants must be at least 12 years old, weigh at least 25 kg, have completed treatment in a previous amlitelimab study, and be able to attend visits and follow procedures.

Main exclusion criteria: Those with severe allergies, other skin conditions, certain infections, weakened immune systems, history of cancer, pregnancy or breastfeeding, recent vaccines, major surgery, or substance abuse are excluded.

Trial focus: The study monitors long-term safety by tracking treatment-emergent adverse events and assesses whether participants maintain improvements in skin condition over time.

Investigational drug: Amlitelimab is administered as a subcutaneous injection and works by targeting specific immune pathways to reduce inflammation and alleviate atopic dermatitis symptoms.

Study on Reducing Dupilumab Dose for Patients with Controlled Atopic Eczema

This Dutch trial studies whether dupilumab dosing frequency can be reduced from every 2 weeks to every 3 or 4 weeks while maintaining disease control in patients whose atopic eczema is well-controlled with the standard regimen.

Main inclusion criteria: Participants must be adults with a diagnosis of atopic eczema, currently receiving dupilumab 300 mg every 2 weeks, and have controlled disease according to specific criteria. They must provide informed consent.

Main exclusion criteria: Those with severe allergies, currently participating in other trials, other interfering skin conditions, recent use of certain medications, poorly controlled chronic diseases, pregnancy or breastfeeding, or substance abuse history are excluded.

Trial focus: The study evaluates whether reducing dupilumab frequency maintains disease control, measuring outcomes at weeks 16 and 24 using various severity scales and quality of life questionnaires.

Investigational drug: Dupilumab is a monoclonal antibody that blocks IL-4 and IL-13 proteins involved in inflammation, helping reduce eczema symptoms when given as a subcutaneous injection.

Study on the Effectiveness and Safety of Lebrikizumab for Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis

This trial evaluates lebrikizumab, a monoclonal antibody targeting IL-13, for treating moderate-to-severe atopic dermatitis in adults and adolescents aged 12 and older over a 24-week period.

Main inclusion criteria: Participants must be aged 12-18 (weighing at least 40 kg) or adults suitable for systemic therapy. They must have had chronic atopic dermatitis for at least 1 year, with EASI score ≥12, IGA score ≥3, at least 10% body surface area affected, and significant itching (pruritus score ≥4). They must have inadequate response to topical treatments.

Main exclusion criteria: Those with other interfering skin conditions, recent use of certain medications, severe allergies, certain infections, history of cancer, pregnant or breastfeeding women, recent participation in other trials, or inability to follow procedures are excluded.

Trial focus: The primary goal is achieving significant improvement in EASI score by week 24. Secondary outcomes include achieving clear or almost clear skin (IGA score) and improvements in itching severity.

Investigational drug: Lebrikizumab is administered as a subcutaneous injection and works by blocking IL-13, a key protein involved in inflammation and atopic dermatitis symptoms.

Summary

There are currently 69 clinical trials for atopic dermatitis being conducted across Europe, representing a significant effort to develop new treatments for this challenging skin condition. These trials are geographically concentrated in several European countries, with Germany, Poland, France, Spain, and Italy hosting the most studies.

The trials test diverse treatment approaches including:

  • Oral medications such as upadacitinib, abrocitinib, baricitinib, and various investigational tablets targeting JAK pathways
  • Injectable biologics like lebrikizumab, amlitelimab, tralokinumab, dupilumab, nemolizumab, and rocatinlimab that target specific immune proteins
  • Topical treatments including ruxolitinib cream and various corticosteroid formulations

Several notable patterns emerge: many trials focus on patients with moderate-to-severe disease who have inadequate response to topical treatments, indicating a clear unmet need for more effective therapies in this population. Multiple studies also investigate treatment combinations, particularly biologics or oral medications used alongside topical corticosteroids.

A significant number of trials specifically target pediatric populations, including children as young as 6 months, reflecting the importance of developing safe and effective treatments for younger patients who often suffer from this condition. Long-term extension studies are also included, demonstrating the emphasis on understanding the safety profile of new medications over extended treatment periods.

This comprehensive research effort offers hope for patients with atopic dermatitis by expanding treatment options and working toward more personalized approaches based on individual patient characteristics and treatment responses.

Ongoing Clinical Trials on Dermatitis atopic

  • JNJ-95597528 for Adults with Moderate to Severe Atopic Dermatitis

    Recruiting

    Investigated diseases:
    Germany Poland
  • Long-Term Safety and Efficacy of Lebrikizumab in Children and Adolescents With Moderate-to-Severe Atopic Dermatitis

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Poland Spain
  • Study of GHZ339 for treatment of moderate to severe atopic dermatitis

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Hungary Italy The Netherlands +3
  • Study on Amlitelimab for Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis Using Topical Corticosteroids and Inadequate Response to Previous Treatments

    Recruiting

    1 1 1
    Investigated diseases:
    France Germany Greece Italy The Netherlands Poland +1
  • Study on Long-Term Safety and Efficacy of Amlitelimab for Patients with Moderate to Severe Atopic Dermatitis from Previous Trials

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Denmark France Germany Greece +7
  • Study on the Safety and Effectiveness of Upadacitinib and Dupilumab for Children Aged 2 to 12 with Moderate to Severe Atopic Dermatitis

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Bulgaria Croatia France Germany Hungary +6
  • Testing GIA632 compared to placebo in adults with moderate to severe atopic dermatitis to measure effectiveness and safety

    Not yet recruiting

    Investigated diseases:
    Bulgaria Czechia France Germany Poland
  • Study on Eblasakimab for Adults with Moderate-to-Severe Atopic Dermatitis Previously Treated with Dupilumab

    Not yet recruiting

    Investigated diseases:
    Germany Poland
  • Study on Amlitelimab for Patients Aged 12 and Older with Moderate-to-Severe Atopic Dermatitis

    Not recruiting

    1 1 1
    Investigated diseases:
    Bulgaria Czechia Denmark Italy Portugal Spain +1
  • Study on the Effectiveness and Safety of BP1.7881 for Adults with Moderate-to-Severe Atopic Dermatitis

    Not recruiting

    Investigated diseases:
    Investigated drugs:
    France Germany Poland