What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis that target immune pathways include monoclonal antibodies like dupilumab. Known side effects of dupilumab include eye inflammation, eosinophilia, and cutaneous T-cell lymphomas, although the latter may not be directly related to the drug. Other side effects can include injection site reactions and potential ocular adverse events. Overall, dupilumab is well-tolerated, but long-term safety data are still being gathered.

What prior FDA approvals exist?

Dupilumab is a monoclonal antibody that targets the IL-4 and IL-13 pathways and has been approved by the FDA for the treatment of moderate-to-severe atopic dermatitis. It has shown long-term effectiveness and safety in clinical practice. Other monoclonal antibodies like Tralokinumab, which targets the IL-13 pathway, have also been studied and shown efficacy in clinical trials. These treatments represent a significant advancement in targeting specific immune pathways involved in atopic dermatitis.

What other types of research exist?

Promising novel alternatives to Rocatinlimab for Atopic Dermatitis patients include Dupilumab, an IL-4 receptor alpha antagonist, and Tralokinumab, an IL-13 monoclonal antibody. Both have shown significant efficacy and safety in treating moderate-to-severe AD and are viable options for patients considering treatment in 2024.

← Back to Search

Monoclonal Antibodies

Rocatinlimab for Atopic Dermatitis (ROCKET-ASTRO Trial)

Verified 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

Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent

Body weight ≥ 40 kg at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called rocatinlimab to see if it works and is safe for teenagers. The medication can be used by itself or with other treatments. It aims to help by interacting with the immune system.

Who is the study for?

Adolescents aged 12-17 with moderate-to-severe atopic dermatitis (eczema) who haven't responded well to certain creams and ointments can join. They must weigh at least 40 kg, have a significant area of their body affected, and experience notable itchiness. Those who've used strong medications or therapies for eczema in the month before the trial starts cannot participate.

What is being tested?

The study is testing Rocatinlimab's effectiveness and safety as a solo treatment or combined with other treatments for adolescents with severe skin inflammation due to eczema. Some participants will receive Rocatinlimab while others will get a placebo (a substance with no active drug).

What are the potential side effects?

Possible side effects of Rocatinlimab may include reactions at the injection site, increased risk of infections, headaches, and potential effects on the immune system. The exact side effects are not listed but are being studied.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with atopic dermatitis for over a year.

Select...

I weigh at least 40 kg.

Select...

My skin condition didn't improve with strong steroid creams.

Select...

Your EASI score is 12 or higher when first checked.

Select...

Your EASI score is 16 or higher on the first day of the study.

Select...

Your vIGA-AD score is 3 or higher.

Select...

Over 10% of my skin is affected by atopic dermatitis.

Select...

I have severe itching rated 4 or higher on a scale.

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

4Treatment groups

Experimental Treatment

Group I: Arm D: Open-Label Dose 1Experimental Treatment1 Intervention

Part 2; Week 24 to Week 52: Part 1 Non-Responders will be reassigned at Week 24 with Rocatinlimab Open-label Dose 1 Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). Participants in Arms A, B or C Maintenance Period will be reassigned with Rocatinlimab Open-label Dose 1 Q4W (with TCS/TCI if within combination therapy cohort) upon relapse after Week 24.

Group II: Arm C: PlaceboExperimental Treatment2 Interventions

Part 1 (Initial Period); Week 0 to Week 24: Placebo Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be reassigned at Week 24 with Placebo Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort).

Group III: Arm B: Dose 2Experimental Treatment1 Intervention

Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 2 Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 2 Q4W or Q8W for 28 weeks (with TCS/TCI if within combination therapy cohort).

Group IV: Arm A: Dose 1Experimental Treatment1 Intervention

Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with loading dose at Week 2 (+ topical corticosteroids (TCS)/ topical calcineurin inhibitor (TCI) if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 1 Q4W or every 8 weeks (Q8W) for 28 weeks (+ TCS/TCI if within combination therapy cohort).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rocatinlimab

2023

Completed Phase 3

~1720

Placebo

1995

Completed Phase 3

~2670

0 / 8Eligibility 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 pathways involved in the inflammatory response. Monoclonal antibodies, such as Rocatinlimab, work by specifically targeting and inhibiting cytokines or their receptors, which are key players in the immune response. For example, Dupilumab targets the IL-4 and IL-13 pathways, reducing inflammation and pruritus. This is crucial for AD patients as it directly addresses the underlying immune dysregulation, leading to significant improvements in symptoms and quality of life. By modulating the immune system, these treatments can provide more effective and sustained relief compared to traditional therapies.

Recent developments in atopic dermatitis.