This clinical trial focuses on treating Atopic Dermatitis, a chronic skin condition that causes itching and inflammation. The study tests a medication called rocatinlimab (also known as AMG 451) used together with topical corticosteroids and/or topical calcineurin inhibitors, which are medicines applied directly to the skin. The purpose is to determine if this combination treatment is effective and safe for adults with moderate-to-severe atopic dermatitis.
The study involves two groups of participants – one receiving rocatinlimab injections under the skin along with topical treatments, and another receiving placebo injections with the same topical treatments. The treatment period lasts for 24 weeks, during which the effectiveness of the medication will be evaluated by examining improvements in skin appearance and reduction in disease severity.
Throughout the study, doctors will monitor how well the treatment works by checking if participants’ skin becomes clearer and if their symptoms, such as itching and skin pain, improve. They will pay special attention to how the treatment affects different areas of the body, including the face and hands, in people who have atopic dermatitis in these locations.
1Initial assessment
Your skin condition will be evaluated to confirm you have moderate-to-severe atopic dermatitis that has been present for at least 12 months
The affected area must cover at least 10% of your body surface and meet specific severity criteria
Your itching severity will be measured using a numeric rating scale
2Treatment assignment
You will be randomly assigned to receive either rocatinlimab or placebo
The medication will be given as an injection under the skin
You will also receive topical treatments (skin creams) containing corticosteroids and/or calcineurin inhibitors
316-week assessment
Your skin condition will be evaluated to measure improvement
The severity of itching and skin pain will be assessed
Special attention will be given to facial and hand areas if they were affected at the start
424-week final assessment
Final evaluation of your skin condition will be performed
The assessment will measure whether your skin is clear or almost clear
The overall improvement in your eczema will be calculated
Pain levels and specific areas like face and hands will be evaluated again
Who Can Join the Study?
Must be aged 18 years or older with confirmed atopic dermatitis that has been present for at least 12 months
Must have a history of inadequate response to medium or higher potency topical corticosteroids (medicated creams or ointments applied to the skin) with or without topical calcineurin inhibitors (another type of skin medication)
Must have moderate to severe atopic dermatitis with the following characteristics:
An EASI score of 16 or higher (a measure of disease severity)
A vIGA-AD score of 3 or higher (doctor’s assessment of disease severity)
Atopic dermatitis affecting at least 10% of body surface area
A score of 4 or higher on the pruritus (itching) scale
Can be either male or female
Must be able to provide informed consent to participate in the study
Who Cannot Join the Study?
Prior treatment with rocatinlimab or any other similar medications targeting atopic dermatitis
Active skin infection that requires treatment (such as bacterial, fungal, or viral infections)
Other significant skin conditions that could interfere with the evaluation of atopic dermatitis
Current use of systemic medications that suppress the immune system
History of severe allergic reactions to medications
Participation in another clinical trial within the past 30 days
Pregnant or breastfeeding women
Major surgery planned during the study period
Significant heart, liver, or kidney disease
Active or chronic infections like hepatitis B, hepatitis C, HIV, or tuberculosis
History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
Unstable or poorly controlled medical conditions that could affect study participation
Current substance abuse or mental health conditions that could interfere with study compliance
Unable to follow study procedures or attend scheduled visits
Rocatinlimab (also known as AMG 451) is a medication being studied for treating moderate-to-severe atopic dermatitis (eczema). It works by targeting specific components of the immune system that are involved in causing skin inflammation.
Topical corticosteroids are anti-inflammatory medications that are applied directly to the skin. They help reduce redness, itching, and swelling associated with atopic dermatitis.
Topical calcineurin inhibitors are medications applied to the skin that help control inflammation and reduce symptoms of atopic dermatitis. They work by suppressing the immune response in the skin and are often used when corticosteroids aren’t appropriate or aren’t providing enough relief.
Atopic Dermatitis – A chronic inflammatory skin condition that causes dry, itchy, and inflamed skin. The condition typically begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. It commonly appears as red, scaly patches on the skin, particularly in areas like the face, hands, elbows, and knees. The condition is characterized by intense itching, which can lead to scratching and further skin damage. People with atopic dermatitis often experience skin barrier dysfunction, making their skin more sensitive to environmental triggers and allergens.
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