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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

Summary

This trial will assess the safety, effectiveness, and immunogenicity of a new vaccine to protect against tetanus and meningococcal disease.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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 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 1
~20

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.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,392 Previous Clinical Trials
1,380,925 Total Patients Enrolled
MDStudy DirectorAmgen
937 Previous Clinical Trials
927,072 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05899816 — Phase 3
Atopic Dermatitis Research Study Groups: Rocatinlimab, Placebo
Atopic Dermatitis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05899816 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05899816 — Phase 3
~14 spots leftby Sep 2024