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

Fast replyInvestigationalNo 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 aims to evaluate the effectiveness, safety, and tolerability of rocatinlimab (also known as AMG 451) in treating adults with moderate-to-severe atopic dermatitis. Atopic dermatitis is a chronic inflammatory skin condition characterized by itchy, red, and inflamed skin patches, commonly known as eczema. The study will compare the effects of rocatinlimab monotherapy (treatment with only this medication) against a placebo over a 24-week period.

The research will assess whether rocatinlimab can improve the condition of patients' skin by reducing the severity and affected areas of eczema. The study will measure improvements in skin appearance, reduction in pruritus (itching), decrease in skin pain, and overall quality of life for participants. It will specifically examine whether participants achieve clear or almost clear skin on their face, hands, and other body areas after treatment.

Throughout the 24-week study period, participants will receive either rocatinlimab or placebo and will need to regularly report their symptoms and complete assessments. The research is designed for adults who have had atopic dermatitis for at least 12 months and have not responded adequately to previous treatments for their condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study Enrollment and Initial Assessment

    After joining the study, your moderate-to-severe atopic dermatitis (a chronic, itchy skin condition also known as eczema) will be assessed using several measurements including the Eczema Area and Severity Index (EASI) and the Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).

    Your itching severity will be measured using a numerical rating scale, and you will need to have a score of at least 4 on this scale to participate.

    The study will confirm that you have had atopic dermatitis for at least 12 months and have not responded adequately to previous treatments.

  2. Step 2

    Random Assignment to Treatment Group

    You will be randomly assigned to receive either rocatinlimab (AMG 451) or a placebo (an injection that contains no active medication).

    Neither you nor the study doctor will know which treatment you are receiving. This is called a 'double-blind' study.

  3. Step 3

    Treatment Period (24 weeks)

    You will receive injections of either rocatinlimab or placebo for 24 weeks (approximately 6 months).

    The medication will be administered as a solution for injection, though the exact dosage and frequency of injections are not specified in the provided information.

  4. Step 4

    Regular Assessments

    Throughout the 24-week period, your skin condition will be regularly evaluated by healthcare professionals.

    You will need to complete daily scoring of your itching severity.

    You will also need to complete weekly scoring of your eczema skin pain.

    Your quality of life will be assessed using the Dermatology Life Quality Index (DLQI), which measures how your skin condition affects your daily life.

  5. Step 5

    Key Assessment at Week 16

    At week 16, your skin will be evaluated to determine if it has become clear or almost clear based on the vIGA-AD scale.

    Your itching severity will also be assessed at this point to determine if there has been improvement compared to the beginning of the study.

  6. Step 6

    Final Assessment at Week 24

    At the end of the 24-week study period, comprehensive assessments will be conducted to evaluate the effectiveness of the treatment.

    These assessments include checking whether your eczema has improved by at least 75% based on the EASI score.

    Your skin will be evaluated to determine if it has become clear or almost clear.

    Specific attention will be given to checking whether there is clear skin on your face and hands.

    Your itching severity, eczema skin pain, and quality of life will be assessed to determine improvements compared to the start of the study.

Who can join the trial?

5 criteria

  • Age 18 or older with atopic dermatitis (a chronic, itchy skin condition also known as eczema) that has been present for at least 12 months, diagnosed according to the American Academy of Dermatology Consensus Criteria from 2014
  • History of not responding well enough to certain previous medications used to treat atopic dermatitis
  • EASI score of 16 or higher (this is a measurement tool that evaluates the severity and extent of eczema on different body areas)
  • vIGA-AD score of 3 or higher (this is a tool doctors use to assess the overall severity of atopic dermatitis; a score of 3 means moderate to severe disease)
  • Worst pruritus numerical rating scale of 4 or higher (this means your itching severity, when at its worst, is at least moderate on a scale where patients rate their itching from 0 to 10)

Who cannot join the trial?

16 criteria

  • Current diagnosis of erythrodermic atopic dermatitis (a severe form of skin inflammation that affects most of the body)
  • Prior use of rocatinlimab (the study medication)
  • Prior use of lebrikizumab (another medication for atopic dermatitis) within 6 months of screening
  • Recent use of certain medications including:
    • Systemic antibiotics within 2 weeks before first dose
    • Topical treatments for atopic dermatitis within 2 weeks before first dose
    • Systemic corticosteroids within 4 weeks before first dose
    • Other systemic medications for atopic dermatitis within set time periods
    • History of poor response to 2 or more different systemic therapies for atopic dermatitis
    • Any active skin infection requiring treatment
    • Current or history of certain serious skin conditions other than atopic dermatitis
    • History of any medical condition that could interfere with the study or put you at risk
    • Pregnant or breastfeeding women
    • People with significant laboratory abnormalities
    • People with evidence of active or latent tuberculosis (an infectious disease primarily affecting the lungs)
    • History of cancer within the past 5 years (except certain skin cancers that have been successfully treated)
    • Having received a live vaccine (containing weakened but living microorganisms) within 12 weeks before study start
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Investigated drugs

  • Rocatinlimab (AMG 451)

    is a medication being studied for the treatment of moderate-to-severe atopic dermatitis, which is a chronic inflammatory skin condition also known as eczema. It works by targeting specific parts of the immune system that are involved in causing the inflammation and symptoms of atopic dermatitis. In this study, researchers are testing whether this medication can reduce the severity and affected area of eczema compared to a placebo.

  • Placebo

    is an inactive substance that looks like the medication being tested but contains no active ingredient. It's used as a comparison to determine if the active medication (rocatinlimab) produces real benefits.

What is already known about the treatment

Rocatinlimab (AMG 451) – An injectable monoclonal antibody currently in Phase 3 clinical trials for the treatment of moderate-to-severe atopic dermatitis (eczema) in adults. Rocatinlimab works at the molecular level by targeting specific immune pathways involved in skin inflammation, likely by inhibiting certain cytokines that drive the inflammatory response in atopic dermatitis. As an immunomodulator, this medication aims to reduce symptoms such as itching, redness, and skin lesions by regulating the overactive immune response that characterizes eczema. The ROCKET-Horizon study is evaluating its efficacy and safety as a monotherapy compared to placebo over a 24-week period, with results being measured using standardized assessment tools including the vIGA-AD and EASI scales.

Investigated diseases

Atopic Dermatitis – A chronic inflammatory skin condition characterized by intense itching and red, inflamed skin lesions. It typically presents as dry, scaly patches that can become crusty, oozing, or bleeding when scratched. Atopic dermatitis commonly begins in childhood and often occurs in people who have a personal or family history of allergies or asthma. The condition tends to flare periodically and may be triggered by environmental factors, irritants, stress, or allergens. It frequently affects the face, hands, neck, inner elbows, and backs of the knees. The disease follows a relapsing-remitting course with periods of exacerbation alternating with periods of improvement.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501538-44-00Protocol code20210143Estimated enrolment708 patientsSponsorAmgen Inc.

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