What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis that target immune pathways include monoclonal antibodies like dupilumab and lebrikizumab. Known side effects of dupilumab include injection site reactions, nasopharyngitis, headache, and conjunctivitis. Lebrikizumab, another monoclonal antibody, has been associated with upper respiratory tract infections, nasopharyngitis, headache, injection site pain, and fatigue. These treatments are generally well-tolerated, but patients should be monitored for these potential adverse effects.

What prior FDA approvals exist?

Dupilumab, a monoclonal antibody that targets the IL-4 and IL-13 pathways, was 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 treatments include tralokinumab, another monoclonal antibody targeting IL-13, which has also demonstrated efficacy in clinical trials. These treatments are similar to rocatinlimab, which is being studied for its potential to target immune pathways in atopic dermatitis.

What other types of research exist?

Promising novel alternatives to Rocatinlimab for Atopic Dermatitis patients include Dupilumab, a fully human monoclonal antibody targeting the IL-4 receptor, and Ligelizumab, a humanized IgG1 anti-IgE molecule with higher potency than Omalizumab. Both have shown efficacy in clinical trials and target immune pathways relevant to AD.

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Monoclonal Antibodies

Rocatinlimab for Eczema (ROCKET-Horizon Trial)

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

Common treatments for Atopic Dermatitis (AD) often target specific pathways in the immune system to reduce inflammation and alleviate symptoms. Monoclonal antibodies, such as dupilumab, target cytokines like IL-4 and IL-13, which are involved in the inflammatory response in AD. Rocatinlimab, another monoclonal antibody, is being studied for its efficacy in targeting immune pathways in AD. These treatments are crucial for AD patients as they offer targeted therapy that can reduce the severity of symptoms, improve skin barrier function, and potentially decrease the risk of associated conditions like asthma and allergic rhinitis. By modulating the immune response, these therapies provide a more effective and focused approach to managing moderate-to-severe AD compared to traditional treatments.

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 to week 24

Awards & highlights

Summary

This trial is testing a new medication called rocatinlimab to help people with eczema. The goal is to see if it can reduce the redness, itching, and swelling better than other treatments. The study focuses on patients whose eczema is severe and not well-controlled by other treatments.

Who is the study for?

This trial is for adults with moderate-to-severe atopic dermatitis (AD) who haven't responded well to medium or stronger topical corticosteroids, or when such treatments are not advised. Participants must have a significant itch, extensive rash covering at least 10% of their body, and meet specific severity scores on AD scales.

What is being tested?

The study tests Rocatinlimab's effectiveness against a placebo in improving AD symptoms by week 24. It uses two measures: the vIGA-AD scale assessing overall disease severity and the EASI score evaluating rash area and intensity.

What are the potential side effects?

While specific side effects for Rocatinlimab aren't listed here, common ones for new AD therapies may include injection site reactions, potential immune system changes leading to increased infection risk, headaches, eye irritation or inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 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 Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a ≥ 2 Point Reduction From Baseline (vIGA-AD 0/1) 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 HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8

Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score <8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8

+25 more

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RocatinlimabExperimental Treatment1 Intervention

Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

Group II: PlaceboPlacebo Group1 Intervention

Placebo 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 1

~20

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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 pathways in the immune system to reduce inflammation and alleviate symptoms. Monoclonal antibodies, such as dupilumab, target cytokines like IL-4 and IL-13, which are involved in the inflammatory response in AD. Rocatinlimab, another monoclonal antibody, is being studied for its efficacy in targeting immune pathways in AD. These treatments are crucial for AD patients as they offer targeted therapy that can reduce the severity of symptoms, improve skin barrier function, and potentially decrease the risk of associated conditions like asthma and allergic rhinitis. By modulating the immune response, these therapies provide a more effective and focused approach to managing moderate-to-severe AD compared to traditional treatments.

Recent developments in atopic dermatitis.