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Monoclonal Antibodies

Rocatinlimab for Eczema (ROCKET-Horizon 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
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 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

Side effects data

From 2018 Phase 2 trial • 66 Patients • NCT02647866
14%
Anaemia
12%
Pyrexia
10%
Colitis ulcerative
6%
Chills
6%
Abdominal pain
6%
Arthralgia
4%
Lymphopenia
4%
Mouth ulceration
4%
Sinusitis
4%
Blood creatine phosphokinase increased
4%
Headache
2%
Cough
2%
Colitis
2%
Thrombocytosis
2%
Abdominal pain upper
2%
Diarrhoea
2%
Flatulence
2%
Mucous stools
2%
Pharyngitis
2%
Urinary tract infection
2%
Joint swelling
2%
Oropharyageal pain
2%
Sneezing
2%
Pruritis
2%
Myocardial infarction
2%
Clostridium difficile infection
2%
Pneumonia
2%
Post procedural infection
2%
Blood albumin decreased
2%
Nausea
2%
Chest discomfort
2%
Scar
2%
Blood folate decreased
2%
C-reactive protein increased
2%
Asthenia
2%
Myalgia
2%
Paraesthesia
2%
Anxiety
100%
80%
60%
40%
20%
0%
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 3
~750

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.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,420 Previous Clinical Trials
1,382,224 Total Patients Enrolled
MDStudy DirectorAmgen
961 Previous Clinical Trials
928,139 Total Patients Enrolled

Media Library

Rocatinlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05651711 — Phase 3
Atopic Dermatitis Research Study Groups: Rocatinlimab, Placebo
Atopic Dermatitis Clinical Trial 2023: Rocatinlimab Highlights & Side Effects. Trial Name: NCT05651711 — Phase 3
Rocatinlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05651711 — Phase 3
~264 spots leftby Sep 2025
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