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)

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

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.

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 baseline, week 24

Awards & highlights

ROCKET-SHUTTLE Trial Summary

This trial will assess the effectiveness of a new drug for atopic dermatitis, compared to placebo, at 24 weeks.

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.Check my eligibility

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).See study design

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.

ROCKET-SHUTTLE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Achievement of EASI 75 at Week 16

Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline

Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8

+25 more

ROCKET-SHUTTLE 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.

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.

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Who is running the clinical trial?

AmgenLead Sponsor

1,383 Previous Clinical Trials

1,379,175 Total Patients Enrolled

MDStudy DirectorAmgen

929 Previous Clinical Trials

926,222 Total Patients Enrolled

Media Library

Rocatinlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05724199 — Phase 3

Atopic Dermatitis Research Study Groups: Placebo + TCS/TCI, Rocatinlimab Dose 2 + TCS/TCI, Rocatinlimab Dose 1 + TCS/TCI

Atopic Dermatitis Clinical Trial 2023: Rocatinlimab Highlights & Side Effects. Trial Name: NCT05724199 — Phase 3

Rocatinlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05724199 — Phase 3

Atopic Dermatitis Patient Testimony for trial: Trial Name: NCT05724199 — Phase 3

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