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Study of Rocatinlimab Treatment for Adults and Adolescents 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 focuses on patients with atopic dermatitis, a chronic skin condition that causes itchy, inflamed skin. The research examines a medication called rocatinlimab (also known as AMG 451) that is given as an injection under the skin. The study aims to understand how safe and effective this medication is when used for a long period in people who have moderate to severe forms of atopic dermatitis.

The study is designed to continue treatment for patients who have already participated in previous research with rocatinlimab. Participants will receive either rocatinlimab or placebo through injections under the skin. This is a long-term study that will monitor how well patients maintain improvement in their skin condition and any side effects that may occur during treatment.

The research will track various aspects of the skin condition, including changes in skin appearance, itching severity, and overall symptoms. The study will particularly focus on monitoring the safety of the treatment by recording any side effects and checking laboratory test results and vital signs throughout the treatment period.

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 qualification

    You must have completed treatment in a previous rocatinlimab study

    If you participated in study 20210263, you need to show specific improvement in your EASI score (a measure of atopic dermatitis severity) at Week 52

  2. Step 2

    Treatment assignment

    You will be assigned to receive either rocatinlimab or placebo

    The medication will be given as an injection under the skin (subcutaneous injection)

    Neither you nor your doctor will know which treatment you are receiving (this is called double-blind)

  3. Step 3

    Treatment period

    The study will continue from October 2023 to February 2027

    During this time, your skin condition will be regularly evaluated using several measurement scales:

    - vIGA-AD and rIGA scales (measures of skin appearance)

    - EASI score (measures the extent and severity of skin symptoms)

    - Pruritus NRS score (measures itching intensity)

    Your health will be monitored for any side effects or significant changes in laboratory tests and vital signs

  4. Step 4

    Regular assessments

    Your progress will be tracked to see if improvements in your skin condition are maintained

    The study team will monitor:

    - Any changes in your skin clearance

    - Whether improvements in itching are maintained

    - Any side effects that may occur during treatment

Who can join the trial?

7 criteria

  • You must have completed treatment in a previous rocatinlimab study (a medication for atopic dermatitis)
  • If you participated in study 20210263, you must have shown improvement in your EASI score (a measure of eczema severity) at Week 52
  • You can be either male or female
  • You must be at least 12 years old
  • You must have moderate-to-severe atopic dermatitis (a chronic inflammatory skin condition causing itchy, red, and scaly skin)
  • You must be able to understand and follow study procedures and requirements
  • You must be willing to attend all required study visits and complete study assessments

Who cannot join the trial?

13 criteria

  • History of serious allergic reactions or anaphylaxis (severe, potentially life-threatening allergic reaction)
  • Active or chronic infections, including tuberculosis, hepatitis B, hepatitis C, or HIV
  • Current diagnosis of cancer or history of cancer in the past 5 years
  • Significant heart problems or cardiovascular disease (heart disease affecting blood vessels)
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or significantly reduced kidney function
  • Current participation in other clinical trials or use of investigational drugs within past 30 days
  • Use of other immunosuppressive medications (drugs that reduce immune system activity)
  • Pregnant women, nursing mothers, or those planning pregnancy during the study period
  • History of substance abuse within the past year
  • Major surgery planned during the study period
  • Mental health conditions that could interfere with study participation
  • Any condition that, in the investigator's opinion, makes the patient unsuitable for the study
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Investigated drugs

Rocatinlimab is a medication being studied for treating moderate to severe atopic dermatitis (a serious type of eczema). It is designed to help reduce inflammation and symptoms of atopic dermatitis in both adults and teenagers. This medication works by targeting specific parts of the immune system that are involved in causing skin inflammation and itching.

What is already known about the treatment

Rocatinlimab - A novel investigational monoclonal antibody administered through subcutaneous injection, currently being studied in Phase 3 clinical trials for the treatment of moderate-to-severe atopic dermatitis in both adults and adolescents. The medication works by targeting specific immune system pathways involved in the inflammatory response associated with atopic dermatitis, aiming to reduce skin inflammation and symptoms of the condition. As a biological therapy under the immunomodulator class of medications, rocatinlimab represents a potential long-term treatment option being evaluated for its safety, tolerability, and effectiveness in managing chronic atopic dermatitis symptoms.

Investigated diseases

Atopic Dermatitis - A chronic inflammatory skin condition that causes dry, itchy, and inflamed skin. The condition typically begins in early childhood but can occur at any age and tends to flare up periodically. It causes the skin to become red, scaly, and intensely itchy, often appearing in patches on the face, hands, feet, and in body folds. The condition frequently occurs in people who have a personal or family history of allergies or asthma. During flare-ups, the affected skin may become cracked, raw, or weepy, and the persistent itching can lead to scratching that further damages the skin barrier.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501587-17-00Protocol code20210146Estimated enrolment2 200 patientsSponsorAmgen Inc.

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