A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
NCT ID: NCT05899816
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
221 participants
INTERVENTIONAL
2023-06-07
2024-11-14
Brief Summary
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* estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24
* estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Rocatinlimab
Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Rocatinlimab
Subcutaneous (SC) injection
Placebo
Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Placebo
SC injection
Interventions
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Rocatinlimab
Subcutaneous (SC) injection
Placebo
SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors)
* Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout.
* Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3
Exclusion Criteria
* Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
* Systemic corticosteroids
* Systemic immunosuppressants
* Phototherapy
* Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
* TCS of any potency
* Topical calcineurin inhibitors (TCI)
* Topical Phosphodiesterase-4 inhibitors (PDE4)
* Other topical immunosuppressive agents
* Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents
* Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization.
* Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening
18 Years
54 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Affiliated Dermatology
Scottsdale, Arizona, United States
Center for Dermatology and Plastic Surgery
Scottsdale, Arizona, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Medical Advancement Centers of Arizona
Tempe, Arizona, United States
Little Rock Allergy and Asthma Clinical Research Center
Little Rock, Arkansas, United States
Kern Research Inc
Bakersfield, California, United States
Hope Clinical Research LLC
Canoga Park, California, United States
Doc1 Healthcare Systems
Chino, California, United States
310 Clinical Research
Inglewood, California, United States
Chemidox Clinical Trials Incorporated
Lancaster, California, United States
Long Beach Research Institute
Long Beach, California, United States
University of California Los Angeles
Los Angeles, California, United States
Wallace Medical Group Inc
Los Angeles, California, United States
West Los Angeles Clinical Trials
Los Angeles, California, United States
Northridge Clinical Trials
Northridge, California, United States
Havana Research Institute Inc
Pasadena, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
Wake Research Medical Center for Clinical Research
San Diego, California, United States
Cura Clinical Research
Sherman Oaks, California, United States
Wolverine Clinical Trials
Tustin, California, United States
Alliance for Multispecialty Research
Coral Gables, Florida, United States
Life Clinical Trials
Coral Springs, Florida, United States
AllerVie Clinical Research- Destin
Destin, Florida, United States
D and H Doral Research Centers
Doral, Florida, United States
Saint Jude Clinical Research
Doral, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Nexus Clinical Research
Homestead, Florida, United States
D and H National Research Centers
Miami, Florida, United States
Gold Coast Health Research Center
Miami, Florida, United States
Anchor Medical Research
Miami, Florida, United States
Meridian International Research
Miami Gardens, Florida, United States
AllerVie Clinical Research- Ocala
Ocala, Florida, United States
D and H Tamarac Research Centers
Tamarac, Florida, United States
Hamilton Research, LLC
Alpharetta, Georgia, United States
Divine Dermatology and Aesthetics
Atlanta, Georgia, United States
MetroDerm / Atlanta Center for Clinical Research, LLC
Atlanta, Georgia, United States
First Georgia Physicians Group
Fayetteville, Georgia, United States
Dermatologic Surgery Specialists
Macon, Georgia, United States
McIntosh Clinic PC
Thomasville, Georgia, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Southern Indiana Clinical Trials
New Albany, Indiana, United States
Dermatology and Skin Cancer Center Leawood
Leawood, Kansas, United States
Visage Dermatology and Aesthetic Center
Largo, Maryland, United States
ActivMed Practices and Research, LLC
Methuen, Massachusetts, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
The Derm Institute of West Michigan
Caledonia, Michigan, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
Skin Cancer and Dermatology Institute
Reno, Nevada, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Pioneer Clinical Research New York
New York, New York, United States
Rochester Clinical Research Inc
Rochester, New York, United States
Hickory Dermatology Research Center
Hickory, North Carolina, United States
Tryon Medical Partners
Matthews, North Carolina, United States
The Skin Surgery Center
Winston-Salem, North Carolina, United States
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, United States
Dermatologist of Central States Clinical Research - Springfield
Springfield, Ohio, United States
Epic Medical Research - Oklahoma
Chickasha, Oklahoma, United States
Unity Clinical Research
Oklahoma City, Oklahoma, United States
Dermatology Research Center of Oklahoma, PLLC
Tulsa, Oklahoma, United States
Velocity Clinical Research Inc
Medford, Oregon, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Cumberland Skin Center
Hermitage, Tennessee, United States
MedCare Pharma - Houston
Houston, Texas, United States
sms Clinical Research Limited Liability Company
Mesquite, Texas, United States
Stryde Research - Epiphany Dermatology
Southlake, Texas, United States
Tranquil Clinical Research
Webster, Texas, United States
Cope Family Medicine
Bountiful, Utah, United States
Tanner Clinic
Murray, Utah, United States
Skin Physicians Dermatology
Edmonton, Alberta, Canada
Interior Dermatology Centre
Kelowna, British Columbia, Canada
Karma Clinical Trials
St. John's, Newfoundland and Labrador, Canada
Skincare Studio
St. John's, Newfoundland and Labrador, Canada
Kingsway Clinical Research
Etobicoke, Ontario, Canada
Guelph Dermatology Research
Guelph, Ontario, Canada
York Dermatology Centre
Richmond Hill, Ontario, Canada
FACET Dermatology
Toronto, Ontario, Canada
Evidence Based Medical Educator Inc
Toronto, Ontario, Canada
DermAtelier Clinical Research Incorporated
Toronto, Ontario, Canada
Clinique de Dermatologie Rosemont
Montreal, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, Canada
Sima recherche
Verdun, Quebec, Canada
Countries
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References
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Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20210158
Identifier Type: -
Identifier Source: org_study_id
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