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Study of rocatinlimab (AMG 451) in adolescents with moderate to severe atopic dermatitis to evaluate its effectiveness and safety over 52 weeks

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 study focuses on testing a medication called rocatinlimab (also known as AMG 451) for treating atopic dermatitis, a chronic skin condition that causes itchy, inflamed, and red skin. The study aims to determine how well this medication works and how safe it is for adolescents with moderate to severe forms of the condition.

The research will compare rocatinlimab against placebo in adolescents who have not responded well enough to previous treatments with topical corticosteroids. The study will last for 52 weeks, with the main evaluation of the medication's effectiveness happening at week 24. During the study, researchers will monitor changes in the severity of skin symptoms and the intensity of itching.

Throughout the study, participants will receive either rocatinlimab or placebo through injections. The study will measure several aspects of the skin condition, including how much of the body is affected by the disease, the severity of symptoms, and improvements in itching and skin pain. This is known as a double-blind study, which means neither the participants nor the doctors conducting the study will know who is receiving the actual medication versus the placebo during the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening visit

    During the first visit, your atopic dermatitis (AD) will be evaluated to confirm it meets the required severity level

    The medical team will verify that you have had AD for at least 12 months

    Your previous treatment history with topical corticosteroids will be reviewed

    Assessment of your skin condition using the Eczema Area and Severity Index (EASI) will be performed

  2. Step 2

    Day 1 - Start of treatment

    Your skin condition will be reassessed to confirm eligibility

    You will be randomly assigned to receive either rocatinlimab or a placebo

    You will receive instructions on how to use the study medication

    You will begin tracking your skin symptoms using a rating scale for itching and pain

  3. Step 3

    Treatment period - Weeks 1-24

    Regular visits to evaluate your skin condition will be scheduled

    Your response to treatment will be monitored using the EASI score

    You will continue recording daily ratings of itching and skin pain

    The medical team will monitor any changes in your condition

  4. Step 4

    Week 24 evaluation

    A comprehensive assessment of your skin condition will be performed

    The effectiveness of the treatment will be evaluated

    Your EASI score will be measured

    Your reported symptoms of itching and skin pain will be reviewed

  5. Step 5

    Continued treatment - Weeks 24-52

    You may be reassigned to a different treatment group

    Treatment and monitoring will continue for an additional 28 weeks

    Regular assessments of your skin condition will continue

    The study will conclude at week 52

Who can join the trial?

9 criteria

  • Age between 12 and 17 years old at the start of the study
  • Must have Atopic Dermatitis (a chronic skin condition causing itchy, inflamed skin) that has been present for at least 12 months before joining the study
  • Must have had an inadequate response to topical corticosteroids (skin creams containing steroids) of medium to high strength, which means:
    • The treatment did not improve the condition despite using the cream daily for at least 28 days, or
    • The treatment could not be used due to side effects or safety concerns
    • Must have moderate to severe Atopic Dermatitis at both the screening visit and the first day of the study, measured by:
      • A score of at least 12 on the EASI (Eczema Area and Severity Index - a tool that measures the severity and extent of eczema) at screening
      • A score of at least 16 on the EASI on day 1 of the study
      • A certain level of itching severity based on a 7-day assessment
      • Both males and females can participate
      • Previous users of systemic treatments (medications taken by mouth or injection) for Atopic Dermatitis may participate after an appropriate waiting period

Who cannot join the trial?

16 criteria

  • Previous participation in a study involving rocatinlimab (an experimental medication)
  • Active or chronic infections, including:
    • Tuberculosis (a bacterial infection affecting the lungs)
    • Hepatitis B or C (viral infections affecting the liver)
    • HIV (Human Immunodeficiency Virus)
    • History of cancer in the past 5 years (except successfully treated skin cancer)
    • Severe liver problems or abnormal liver function tests
    • Pregnant or breastfeeding women
    • Planning pregnancy during the study period
    • Use of other investigational drugs within 8 weeks before the study
    • Major surgery in the past 8 weeks
    • Serious heart conditions
    • Uncontrolled high blood pressure
    • History of severe allergic reactions to injectable medications
    • Current use of other medications for atopic dermatitis that could interfere with the study
    • Mental health conditions that could affect participation in the study
    • Drug or alcohol abuse in the past year
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Investigated drugs

Rocatinlimab (also known as AMG 451) is an investigational medication designed to treat moderate-to-severe atopic dermatitis, which is a chronic inflammatory skin condition that causes itchy, red, and swollen skin. This medication is being studied as a potential treatment option for adolescents with this condition. It works by targeting specific components of the immune system that are involved in causing skin inflammation.

What is already known about the treatment

Rocatinlimab – A novel investigational monoclonal antibody administered via subcutaneous injection, currently being studied in Phase 3 clinical trials for the treatment of moderate-to-severe atopic dermatitis in adolescent patients. This biological medication works by targeting specific immune system pathways involved in the inflammatory response associated with atopic dermatitis, aiming to reduce skin inflammation and improve symptoms. As an immunomodulating agent, it represents a new approach in managing chronic skin conditions, with ongoing research evaluating its efficacy and safety profile through the ROCKET-ASTRO clinical trial program.

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 affect people of any age. It is characterized by periods of flare-ups where the skin becomes red, cracked, and intensely itchy, alternating with periods of relative calm. The condition often appears in patches on the hands, feet, ankles, neck, upper body, and limbs. People with atopic dermatitis may experience thickening of the skin in affected areas over time, and the condition is frequently associated with other allergic conditions.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2022-501586-50-00Protocol code20210145Estimated enrolment512 patientsSponsorAmgen Inc.

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