What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical corticosteroids, calcineurin inhibitors (like tacrolimus and pimecrolimus), and biologics such as dupilumab. Topical corticosteroids can cause skin thinning, stretch marks, and systemic effects if used long-term. Calcineurin inhibitors may cause burning or itching at the application site and have a black box warning for potential cancer risk. Dupilumab, a biologic, can lead to injection site reactions, conjunctivitis, and facial redness. Janus kinase inhibitors, another class of treatment, may cause nasopharyngitis, headache, and increased risk of infections. Specific side effects for OX40 inhibition treatments like Rocatinlimab are not detailed in the provided context.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, including biologics and topical therapies. Dupilumab, an IL-4 and IL-13 inhibitor, is one of the most notable biologics approved for moderate-to-severe atopic dermatitis. Other treatments include topical corticosteroids, calcineurin inhibitors like tacrolimus and pimecrolimus, and phosphodiesterase 4 inhibitors such as crisaborole. While specific FDA approvals for OX40 inhibitors like Rocatinlimab are not mentioned, these treatments represent the current landscape of approved therapies for atopic dermatitis.

What other types of research exist?

Promising, novel alternatives to Rocatinlimab for Atopic Dermatitis patients in 2024 include Dupilumab, Delgocitinib, and Tofacitinib.

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Monoclonal Antibodies

Rocatinlimab for Eczema (ROCKET-Ignite Trial)

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

Common treatments for Atopic Dermatitis (AD) target various pathways involved in the inflammatory response. Rocatinlimab, an OX40 inhibitor, works by blocking the OX40-OX40L interaction, which is crucial for T-cell activation and survival, thereby reducing inflammation. JAK inhibitors, such as baricitinib, interfere with the Janus kinase pathways that mediate cytokine signaling, leading to decreased inflammation and pruritus. IL-31 antibodies like nemolizumab target the IL-31 receptor, reducing chronic itch and skin inflammation. Traditional treatments, including topical corticosteroids and calcineurin inhibitors, suppress the immune response and decrease inflammation locally. Understanding these mechanisms helps AD patients and their doctors choose the most effective treatment based on the specific inflammatory pathways involved in their condition.

Phase 3

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months

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

Must not have

Have you ever used topical steroid creams (i.e hydrocortisone)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 24

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called rocatinlimab to see if it works well and is safe when used alone. It targets patients who might benefit from a new treatment option.

Who is the study for?

Adults with moderate-to-severe atopic dermatitis (eczema) who haven't responded well to strong topical corticosteroids, or creams that suppress the immune system, may qualify. They should have a significant area of their body affected and experience intense itching. Those recently treated with biologics, systemic steroids, other immunosuppressants, phototherapy or certain inhibitors can't participate.

What is being tested?

The trial is testing Rocatinlimab's effectiveness and safety as a standalone treatment for eczema compared to a placebo. Participants will be randomly assigned to receive either Rocatinlimab or an inactive substance without knowing which one they are receiving.

What are the potential side effects?

Potential side effects of Rocatinlimab could include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, and possible effects on liver enzymes. The exact side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am over 18 and have been diagnosed with atopic dermatitis for at least a year.

Select...

My skin condition didn't improve after using strong creams or ointments in the last 6 months.

Select...

Your Eczema Area and Severity Index (EASI) score is 16 or higher.

Select...

Your vIGA-AD score is 3 or higher.

Select...

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

Select...

I often feel itchy, rating my itchiness at least 4 out of 10.

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 24

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

Treatment Details

Study Objectives

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

Primary study objectives

Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with ≥2 point reduction from baseline at Week 24

Achievement of ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24

Secondary study objectives

Achievement of Facial AD Severity Score of Clear at week 24 for subjects with facial AD at baseline

Achievement of Genital AD Severity Score of Clear at week 24 for subjects with genital AD at baseline

Achievement of HADS-depression subscale score < 8 at week 24 in subjects with baseline HADS-depression subscale score ≥ 8

+22 more

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm BExperimental Treatment1 Intervention

Rocatinlimab Dose 2 Q4W + loading dose at Week 2

Group II: Arm AExperimental Treatment1 Intervention

Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2

Group III: Arm CPlacebo Group1 Intervention

Placebo Q4W+ loading dose at Week 2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rocatinlimab

2024

Completed Phase 3

~750

0 / 7Eligibility 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) target various pathways involved in the inflammatory response. Rocatinlimab, an OX40 inhibitor, works by blocking the OX40-OX40L interaction, which is crucial for T-cell activation and survival, thereby reducing inflammation. JAK inhibitors, such as baricitinib, interfere with the Janus kinase pathways that mediate cytokine signaling, leading to decreased inflammation and pruritus. IL-31 antibodies like nemolizumab target the IL-31 receptor, reducing chronic itch and skin inflammation. Traditional treatments, including topical corticosteroids and calcineurin inhibitors, suppress the immune response and decrease inflammation locally. Understanding these mechanisms helps AD patients and their doctors choose the most effective treatment based on the specific inflammatory pathways involved in their condition.