What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly monoclonal antibodies like dupilumab and nemolizumab, often target immune pathways. Known side effects of these treatments include injection site reactions, conjunctivitis, and nasopharyngitis. Dupilumab has also been associated with facial redness and ocular surface disease. Nemolizumab may cause mild adverse events such as exacerbation of atopic dermatitis. Overall, while these treatments are effective, they can have mild to moderate side effects that should be monitored.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis that target immune pathways. 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 been effective in clinical trials. These treatments, like Rocatinlimab, aim to modulate the immune response involved in atopic dermatitis.

What other types of research exist?

Promising novel alternatives to Rocatinlimab for Atopic Dermatitis patients include Tralokinumab, a monoclonal antibody that neutralizes interleukin-13, and Dupilumab, which targets the interleukin-4 receptor alpha subunit. Both have shown significant efficacy and safety in clinical trials for moderate-to-severe AD.

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Monoclonal Antibodies

Rocatinlimab for Atopic Dermatitis (ROCKET-SHUTTLE Trial)

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial tests a new drug called rocatinlimab combined with common skin treatments on patients with eczema. The goal is to see if this combination works better than standard treatments alone by calming the immune system to reduce symptoms like redness and itching.

Who is the study for?

Adults over 18 with moderate-to-severe atopic dermatitis (AD) for at least a year, who haven't responded well to strong topical corticosteroids. They should have an EASI score of 16 or more, AD covering at least 10% of their body, and significant itchiness. Those recently treated with biologics, systemic steroids or immunosuppressants, phototherapy, Janus kinase inhibitors or certain topicals can't participate.

What is being tested?

The trial is testing Rocatinlimab's effectiveness in combination with standard skin treatments against a placebo mix. It measures improvements in skin condition and severity after 24 weeks using two scales: the vIGA-AD™ for visual assessment and the Eczema Area and Severity Index (EASI).

What are the potential side effects?

Rocatinlimab may cause injection site reactions, headaches, cold-like symptoms (upper respiratory infections), fatigue, and possibly allergic reactions. Topical treatments might lead to skin irritation or thinning if used long-term.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Rocatinlimab Dose 2 + TCS/TCIExperimental Treatment1 Intervention

Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.

Group II: Rocatinlimab Dose 1 + TCS/TCIExperimental Treatment1 Intervention

Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2.

Group III: Placebo + TCS/TCIPlacebo Group1 Intervention

Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rocatinlimab

2023

Completed Phase 3

~1720

Do I qualify?Apply below to find out

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 specific immune pathways to reduce inflammation and immune response. Rocatinlimab, a monoclonal antibody, targets immune pathways involved in AD, similar to dupilumab, which blocks IL-4 and IL-13 signaling, and JAK inhibitors, which interfere with the JAK-STAT pathway. These treatments are crucial for AD patients as they help control the chronic inflammation and immune dysregulation that characterize the disease, leading to reduced symptoms and improved quality of life.

Recent developments in atopic dermatitis.