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Study of Rocatinlimab with Topical Treatments for Adults with Moderate to Severe Atopic Dermatitis

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial 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

  2. Step 2

    Treatment 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

  3. Step 3

    16-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

  4. Step 4

    24-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 trial?

8 criteria

  • 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 trial?

14 criteria

  • 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
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Investigated drugs

  • 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.

What is already known about the treatment

  • Rocatinlimab (AMG 451)

    An investigational monoclonal antibody administered through subcutaneous injection, currently being studied in Phase 3 clinical trials for the treatment of moderate-to-severe atopic dermatitis. The medication is designed to work in combination with topical corticosteroids and/or topical calcineurin inhibitors, targeting specific immune system pathways involved in the inflammatory response associated with atopic dermatitis. As a biologic therapy, rocatinlimab represents a novel approach to managing this chronic skin condition, with ongoing research evaluating its efficacy and safety through standardized measures such as the Validated Investigator's Global Assessment and Eczema Area and Severity Index.

  • Topical Corticosteroids

    Anti-inflammatory medications applied directly to the skin to reduce inflammation, itching, and redness associated with atopic dermatitis. These medications work by suppressing the immune response in the skin and are available in various strengths, from mild to very potent, making them a cornerstone first-line treatment for managing atopic dermatitis flare-ups.

  • Topical Calcineurin Inhibitors

    A class of topical medications that work by blocking specific immune system proteins called calcineurin, which helps reduce inflammation in the skin. These medications are particularly useful for sensitive areas where corticosteroids might be too harsh, such as the face and neck, and serve as an important alternative or complement to topical corticosteroids in the treatment of atopic dermatitis.

Investigated diseases

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.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501585-22-00Protocol code20210144Estimated enrolment715 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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