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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 20 to week 24
Awards & highlights
ROCKET-VOYAGER Trial 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.
ROCKET-VOYAGER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ROCKET-VOYAGER Trial 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
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 • NCT0264786614%
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
ROCKET-VOYAGER 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.
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,371 Previous Clinical Trials
1,378,023 Total Patients Enrolled
MDStudy DirectorAmgen
915 Previous Clinical Trials
924,535 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had systemic treatment for AD but still qualify after a proper washout period.Your skin condition, as assessed by the doctor, is rated as moderate or severe.I haven't used any strong skin medications or treatments in the last week.I haven't had meningococcal or tetanus/diphtheria/pertussis vaccines recently.I have not received any live virus vaccines in the last 12 weeks.I haven't taken any biologic medicines for the past 12 weeks or 5 half-lives, whichever is longer.I haven't taken steroids, immunosuppressants, undergone phototherapy, or used Janus kinase inhibitors recently.I am between 18 and 54 years old and have been diagnosed with atopic dermatitis for at least a year.My skin condition didn't improve with strong creams or ointments.
Research Study Groups:
This trial has the following groups:- Group 1: Rocatinlimab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project accept participants aged 35 or older?
"This research team is accepting patients who are legally of-age (18+) and below 54 years old."
Answered by AI
Are there any specific criteria for enrollment in this medical experiment?
"The trial is seeking to enroll approximately 195 individuals that suffer from atopic dermatitis and are between 18-54 years of age."
Answered by AI
Could you provide me with an overview of the participant count for this trial?
"To run this trial, 195 patients must satisfy the criteria for inclusion. Amgen is overseeing its execution from two locations: Long Beach Research Institute in Georgia and Integrative Skin Science and Research in Nevada."
Answered by AI
Has the FDA granted authorization to Rocatinlimab?
"Rocatinlimab has been adequately demonstrated to be safe, thus it achieved a score of 3 according to our internal rating system. This is due in part because the Phase 3 trial yielded supportive evidence both for efficacy and safety."
Answered by AI
How many locations are currently running the experiment?
"At the moment, this study is enrolling from 6 different healthcare sites; Long Beach, Sacramento and Santa Ana are three of them. To reduce travel costs associated with participation in the trial it would be prudent to select a clinic close to you."
Answered by AI
Is this research project accepting participants at the moment?
"Affirmative. According to the information from clinicaltrials.gov, this medical trial is actively looking for participants; it was first made available on June 7th 2023 and had its most recent update on June 15th 2023. A total of 195 patients are required across 6 distinct locations."
Answered by AI
Who else is applying?
What site did they apply to?
Excel Clinical Research
Sms Clinical Research Limited Liability Company
Other
Hickory Dermatology Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Why did patients apply to this trial?
Suffering 12 years now. Nothing helps for more than a few hours. Need something better than the 3 or 4 meds I’m on for my skin condition.
PatientReceived no prior treatments
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