What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly monoclonal antibodies like dupilumab, can cause side effects such as conjunctivitis, injection site reactions, and eosinophilia. JAK inhibitors, another systemic treatment, may lead to nasopharyngitis, headache, and increased risk of infections. Phototherapy, often used in combination with other treatments, can result in skin burning and an increased risk of skin cancer with prolonged use. These potential side effects should be carefully considered when selecting a treatment strategy.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, particularly focusing on biologics and monoclonal antibodies. Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, has shown long-term effectiveness in treating moderate-to-severe atopic dermatitis. Tralokinumab, another monoclonal antibody, targets IL-13 and has also been approved for similar indications. These treatments, like Rocatinlimab, aim to modulate immune responses, though Rocatinlimab specifically targets OX40 to influence T cell activation and survival. These advancements highlight the growing role of targeted biologic therapies in managing atopic dermatitis.

What other types of research exist?

Promising alternatives to Rocatinlimab for Atopic Dermatitis in 2024 include Dupilumab, which targets the IL-4 receptor alpha subunit, and other emerging treatments such as Lebrikizumab and Tralokinumab, both of which target IL-13. These treatments have shown efficacy and safety in clinical trials for moderate-to-severe AD.

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Monoclonal Antibodies

Rocatinlimab for Eczema (ROCKET-Orbit Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for Atopic Dermatitis (AD) often target the immune system to reduce inflammation and improve symptoms. Rocatinlimab, a monoclonal antibody targeting OX40, modulates T cell activation and survival, addressing the immune dysregulation in AD. Similarly, Dupilumab blocks IL-4 and IL-13 signaling, reducing inflammation and pruritus, while JAK inhibitors like Baricitinib interfere with the JAK-STAT pathway to decrease cytokine signaling. These treatments are important for AD patients as they offer more effective and sustained relief by targeting the root causes of the disease rather than just alleviating symptoms.

Phase 3

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 12 to < 18 years at day 1

History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [TCI])

Must not have

Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 24

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe atopic dermatitis. Rocatinlimab works by reducing inflammation and calming the immune system.

Who is the study for?

Adolescents aged 12 to under 18 with moderate-to-severe atopic dermatitis (AD) who haven't responded well to strong topical corticosteroids or when such treatments are not advised. Participants should have had AD for at least a year, an EASI score of ≥12, and more than 10% body surface area affected.

What is being tested?

The trial is testing the safety and effectiveness of Rocatinlimab in adolescents with AD. It aims to see how well participants tolerate this medication and if it improves their skin condition compared to previous treatments they've tried.

What are the potential side effects?

While specific side effects for Rocatinlimab in this trial aren't listed, common ones for new medications treating skin conditions like AD may include irritation at the injection site, headache, fatigue, nausea, or possible immune system reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 17 years old.

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My skin condition didn't improve with strong creams in the last 6 months.

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At least 10% of my skin is affected by my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any biological medicines for the last 12 weeks or 5 half-lives, whichever is longer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline and Presence of Barely Perceptible Erythema or No Erythema at Week 24

Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24

Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RocatinlimabExperimental Treatment1 Intervention

Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rocatinlimab

2023

Completed Phase 3

~1720

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atopic Dermatitis (AD) often target the immune system to reduce inflammation and improve symptoms. Rocatinlimab, a monoclonal antibody targeting OX40, modulates T cell activation and survival, addressing the immune dysregulation in AD. Similarly, Dupilumab blocks IL-4 and IL-13 signaling, reducing inflammation and pruritus, while JAK inhibitors like Baricitinib interfere with the JAK-STAT pathway to decrease cytokine signaling. These treatments are important for AD patients as they offer more effective and sustained relief by targeting the root causes of the disease rather than just alleviating symptoms.