What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly biologic agents and systemic treatments, have various side effects. Dupilumab can cause injection site reactions, conjunctivitis, and eosinophilia. Tralokinumab, similar to rocatinlimab, may cause upper respiratory infections, injection site reactions, and conjunctivitis. JAK inhibitors like abrocitinib and upadacitinib can lead to nausea, headaches, and increased risk of infections. Traditional systemic treatments such as cyclosporine and methotrexate are associated with nephrotoxicity, hypertension, and hepatotoxicity, respectively. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

Dupilumab, an IL-4 and IL-13 inhibitor, was one of the first monoclonal antibodies approved by the FDA for the treatment of moderate-to-severe atopic dermatitis. It has shown significant efficacy in reducing symptoms and improving quality of life for patients. Other systemic treatments that have been approved include cyclosporine, methotrexate, and azathioprine, which are immunosuppressive agents. More recently, abrocitinib and upadacitinib, which are Janus kinase (JAK) inhibitors, have also been approved for the treatment of moderate-to-severe AD. These treatments offer additional options for patients who do not respond to or cannot use topical therapies.

What other types of research exist?

Promising alternatives to Rocatinlimab for Atopic Dermatitis patients include Dupilumab (an anti-IL-4 receptor alpha monoclonal antibody) and other emerging therapies like Ligelizumab (an anti-IgE monoclonal antibody) and Janus kinase (JAK) inhibitors such as Baricitinib. These treatments have shown efficacy and safety in clinical trials and target key pathways involved in the pathophysiology of AD.

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Monoclonal Antibodies

Rocatinlimab for Atopic Dermatitis/Eczema (ROCKET-ASCEND Trial)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 32

Awards & highlights

Pivotal Trial

Summary

This trial is testing rocatinlimab to see if it is safe and can be tolerated by people with moderate-to-severe eczema. The medication works by calming the immune system to reduce skin inflammation and irritation.

Who is the study for?

This trial is for adults and adolescents with moderate-to-severe atopic dermatitis (AD), commonly known as eczema, who have completed a previous rocatinlimab study within the last 28 days. It's not open to those who had to stop taking the drug due to safety concerns or other rules from earlier studies.

What is being tested?

The trial is testing the long-term effects of a medication called Rocatinlimab on AD. Participants will either continue receiving Rocatinlimab or be given a placebo, which has no active ingredients, to compare outcomes over time.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to Rocatinlimab since understanding its long-term safety and tolerability in treating AD is the main goal of this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 32

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 32

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 32 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Maintaining >= 4-point reduction from parent study baseline in worst pruritus NRS score at week 32

Side effects data

From 2018 Phase 2 trial • 66 Patients • NCT02647866

14%

Anaemia

12%

Pyrexia

10%

Colitis ulcerative

Chills

Abdominal pain

Arthralgia

Lymphopenia

Mouth ulceration

Sinusitis

Blood creatine phosphokinase increased

Headache

Cough

Colitis

Thrombocytosis

Abdominal pain upper

Diarrhoea

Flatulence

Mucous stools

Pharyngitis

Urinary tract infection

Joint swelling

Oropharyageal pain

Sneezing

Pruritis

Myocardial infarction

Clostridium difficile infection

Pneumonia

Post procedural infection

Blood albumin decreased

Nausea

Chest discomfort

Scar

Blood folate decreased

C-reactive protein increased

Asthenia

Myalgia

Paraesthesia

Anxiety

100%

80%

60%

40%

20%

Study treatment Arm

KHK4083 Combined

Placebo

KHK4083 Cohort 1

KHK4083 Cohort 2

KHK4083 Cohort 3

KHK4083 Cohort 4

Awards & Highlights

Pivotal Trial

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

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1Experimental Treatment1 Intervention

Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET- SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received Dose 1, Dose 2, or placebo will be assigned to receive OL Rocatinlimab Dose 1 Q4W. Participants who received OL in parent Rocatinlimab study ROCKET- ASTRO will continue to receive OL Rocatinlimab Dose 1 Q4W. All participants from parent Rocatinlimab study ROCKET-Orbit will be assigned to receive OL Rocatinlimab Dose 1 Q4W.

Group II: ARM B: Dose 2 to Dose 2Experimental Treatment1 Intervention

Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 2 will be randomized or assigned to receive Dose 2 Q4W or Q8W.

Group III: ARM A: Dose 1 to Dose 1Experimental Treatment1 Intervention

Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1 will be randomized or assigned to receive Dose 1 Every 4 Weeks (Q4W) or Every 8 Weeks (Q8W). Participants from parent Rocatinlimab study ROCKET-VOYAGER who received Dose 1 will be assigned to receive Dose 1 Q4W.

Group IV: ARM D: Placebo to PlaceboPlacebo Group1 Intervention

Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received placebo will be randomized or assigned to receive placebo Q4W.

Group V: ARM C: Dose 1 or Dose 2 to PlaceboPlacebo Group1 Intervention

Participants from parent Rocatinlimab studies ROCKET-Ignite or ROCKET-Horizon who received Dose 1 will be randomized to receive placebo Q4W. Participants from parent Rocatinlimab study ROCKET-Ignite who received Dose 2 will be randomized to receive placebo Q4W.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rocatinlimab

2023

Completed Phase 3

~1720

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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 components of the immune system to reduce inflammation and alleviate symptoms. Rocatinlimab, an anti-IL-13 monoclonal antibody, works by inhibiting the activity of IL-13, a cytokine involved in the inflammatory response in AD. Similarly, dupilumab targets the IL-4 and IL-13 pathways, reducing inflammation and improving skin barrier function. JAK inhibitors, another class of treatments, block the signaling pathways of various cytokines, thereby decreasing immune activation. These targeted therapies are significant for AD patients as they directly address the immune dysregulation that causes chronic inflammation, leading to better disease control and improved quality of life.

Recent developments in atopic dermatitis.