What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly those involving monoclonal antibodies like dupilumab, often have side effects such as injection site reactions, conjunctivitis, and nasopharyngitis. Dupilumab, which targets the IL-4Rα receptor, has been associated with ocular surface disease and facial redness. Janus kinase inhibitors, another class of immune-modulating treatments, can cause adverse events like nasopharyngitis and headache. Long-term safety data is still being gathered for newer treatments like delgocitinib and nemolizumab, but they generally show mild to moderate side effects, including exacerbation of atopic dermatitis and pruritus.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies for the treatment of Atopic Dermatitis, focusing on modulating the immune response. Dupilumab, an IL-4 and IL-13 inhibitor, is one such treatment that has shown efficacy in moderate-to-severe cases. Tralokinumab, another monoclonal antibody targeting IL-13, has also been approved for similar indications. These treatments work by targeting specific pathways in the immune system to reduce inflammation and other symptoms associated with Atopic Dermatitis.

What other types of research exist?

Promising alternatives to Rocatinlimab for Atopic Dermatitis patients include Dupilumab, a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling, and Ligelizumab, a humanized IgG1 anti-IgE molecule with higher potency than Omalizumab. Both have shown efficacy in modulating immune responses in allergic conditions and are being evaluated in clinical trials.

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Rocatinlimab for Atopic Dermatitis (ROCKET-VOYAGER Trial)

Verified 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

Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months

History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors)

Must not have

Treatment with a biologic product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 20 to week 24

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called rocatinlimab to see if it changes how well people respond to tetanus and meningococcal vaccines by measuring antibody levels.

Who is the study for?

Adults aged 18-54 with moderate-to-severe atopic dermatitis (AD) for at least a year, who haven't responded well to strong topical corticosteroids or other treatments. Participants should not have used biologics recently, nor received certain vaccines or immunosuppressive therapies within specific time frames before the trial.

What is being tested?

The study is testing Rocatinlimab against a placebo to see if it affects how the body responds to tetanus and meningococcal vaccines. The effectiveness will be measured by comparing antibody responses in both groups after 24 weeks.

What are the potential side effects?

While specific side effects of Rocatinlimab are not listed here, similar medications can cause reactions at the injection site, increased risk of infections, headaches, and possible interference with immune system functions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 54 years old and have been diagnosed with atopic dermatitis for at least a year.

Select...

My skin condition didn't improve with strong creams or ointments.

Exclusion Criteria

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

Select...

I haven't taken any biologic medicines for the past 12 weeks or 5 half-lives, whichever is longer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 20 to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 20 to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 20 to 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

Number of Participants with a Positive Anti-meningococcal Response

Number of Participants with a Positive Anti-tetanus Response

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

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RocatinlimabExperimental Treatment1 Intervention

Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

Group II: PlaceboPlacebo Group1 Intervention

Placebo every 4 weeks (Q4W) for 24 weeks with a 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 / 3Eligibility 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

Atopic Dermatitis (AD) treatments often target the immune system to reduce inflammation and manage symptoms. Monoclonal antibodies, such as Rocatinlimab, work by targeting specific immune pathways. Rocatinlimab targets the OX40 receptor, which plays a role in T-cell activation and inflammation, thereby modulating the immune response to reduce AD symptoms. Other treatments like Dupilumab block IL-4 and IL-13 cytokines, which are involved in the inflammatory process of AD. These targeted therapies are crucial for patients with moderate-to-severe AD as they offer more precise and effective management of the disease compared to traditional treatments like corticosteroids and calcineurin inhibitors, which broadly suppress the immune system.