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Study on Rocatinlimab for Adults with Moderate-to-Severe Atopic Dermatitis

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What is this trial about?

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

This study is examining the effectiveness and safety of rocatinlimab (AMG 451) in treating adults with moderate-to-severe atopic dermatitis. Atopic dermatitis is a chronic inflammatory skin condition characterized by itchy, red, swollen, and cracked skin, commonly known as eczema. The purpose of this research is to evaluate how well rocatinlimab works compared to a placebo over a 24-week period.

The study will assess improvement in atopic dermatitis using several measurements, including the Validated Investigator's Global Assessment for Atopic Dermatitis (a scoring system used by doctors to rate the severity of eczema) and the Eczema Area and Severity Index (a tool that measures the extent and severity of eczema). The research will also track changes in pruritus (itching) and skin pain using numerical rating scales where patients rate their symptoms.

During the 24-week study period, participants will receive either rocatinlimab or placebo treatment. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication versus the placebo until the study is complete. This approach helps ensure that the results aren't influenced by expectations about the treatment.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>participation</b> in the study

    The study involves a period of 24 weeks to assess the effects of the medication on atopic dermatitis, which is a skin condition characterized by inflammation and itching.

    A placebo, which is an inactive substance that looks like the actual medication, or the active medication, rocatinlimab, will be administered.

  2. Step 2

    <b>medication administration</b>

    The medication, rocatinlimab, is provided as a solution for injection.

    The rocatinlimab or the placebo is administered through subcutaneous use, which means it is injected into the layer of fat just under the skin.

    The dosage of rocatinlimab is 9999 mg.

  3. Step 3

    <b>monitoring</b> and <b>evaluation</b>

    At week 16, skin improvements are evaluated using scales to measure the eczema area and severity index (a tool to measure the extent and seriousness of skin inflammation) and the investigator's global assessment (a method for doctors to grade the appearance of the skin).

    Itch levels are measured using a numeric rating scale, where daily worst itching is recorded.

    At week 24, the final assessment is conducted to measure skin clarity, the reduction in eczema severity, and the reduction in skin pain.

Who can join the trial?

7 criteria

  • You must be at least 18 years old or the legal adult age in your country, whichever is older
  • You must have been diagnosed with atopic dermatitis (a chronic, itchy skin condition also known as eczema) that has been present for at least 12 months before joining the study
  • You must have a history of inadequate response to topical treatments (creams or ointments applied to the skin) or have medical reasons why topical treatments are not advisable for you
  • You must have moderate-to-severe atopic dermatitis as defined by:
    • An EASI score (Eczema Area and Severity Index, which measures the extent and severity of eczema) of 16 or higher
    • A vIGA-AD score (Validated Investigator's Global Assessment for Atopic Dermatitis, which rates overall eczema severity) of 3 or higher
    • At least 10% of your body surface area affected by atopic dermatitis
    • A pruritus NRS (Numerical Rating Scale for itching) score of 4 or higher, indicating moderate to severe itching in the past 7 days

Who cannot join the trial?

14 criteria

  • Having a diagnosis other than atopic dermatitis
  • Having used medications that affect the immune system (like systemic immunosuppressants) within a certain period before the study
  • Having used topical treatments for atopic dermatitis within a specified time before the study
  • Having received light therapy (like phototherapy) recently
  • Having an active skin infection that requires treatment
  • Having other skin conditions that might interfere with evaluating atopic dermatitis
  • Being pregnant or breastfeeding
  • Having significant liver or kidney problems
  • Having a history of cancer (except for certain skin cancers that have been completely removed)
  • Having a history of serious infections
  • Having active tuberculosis or other serious infections
  • Having participated in another clinical trial recently
  • Having previously used rocatinlimab (the study medication)
  • Having any condition that, in the opinion of the study doctor, would make it unsafe to participate
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Investigated drugs

  • Rocatinlimab

    (also known as AMG 451) is a medication being studied for the treatment of moderate-to-severe atopic dermatitis, which is a chronic inflammatory skin condition commonly known as eczema. This medication is designed to help reduce inflammation and improve symptoms like itching, redness, and rash that are associated with atopic dermatitis.

  • Placebo

    is a substance that contains no active medication. In this study, it's used as a comparison to determine if rocatinlimab is effective. Some participants receive the actual medication while others receive the placebo, allowing researchers to measure the true effect of the medication.

What is already known about the treatment

Rocatinlimab – An injectable medication currently in Phase 3 clinical trials for the treatment of moderate-to-severe atopic dermatitis in adults. This investigational drug works by targeting and inhibiting the OX40 receptor, which plays a key role in T-cell mediated inflammation involved in atopic dermatitis. Rocatinlimab belongs to the class of monoclonal antibodies and represents a potential new therapeutic approach for patients who don't respond adequately to existing treatments. In clinical studies, its efficacy is being measured through standardized scales including the Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) and the Eczema Area and Severity Index (EASI).

Investigated diseases

Atopic Dermatitis – A chronic inflammatory skin condition characterized by intense itching and red, dry, scaly patches. It typically begins in childhood and may improve or worsen over time, appearing in flares triggered by various environmental factors. Atopic dermatitis often affects the skin folds, such as those inside the elbows, behind the knees, and on the face and neck. The condition can cause significant discomfort due to persistent itching, which may lead to skin damage from scratching. Many patients with atopic dermatitis also have other allergic conditions like asthma or hay fever.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501540-15-00Protocol code20210142Estimated enrolment775 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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