A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
- Conditions
- Atopic DermatitisModerate-to-severe Atopic Dermatitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05899816
- Lead Sponsor
- Amgen
- Brief Summary
The primary objectives of this study are to:
* 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
- 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)
- 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
-
Treatment with a biologic product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2. Rocatinlimab Rocatinlimab Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
- Primary Outcome Measures
Name Time Method Number of Participants with a Positive Anti-tetanus Response Week 20 to week 24 Number of Participants with a Positive Anti-meningococcal Response Week 20 to week 24
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (85)
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
McIntosh Clinic PC
🇺🇸Thomasville, Georgia, 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
Meridian International Research
🇺🇸Miami Gardens, 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
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
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
🇨🇦Saint 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
Sima recherche
🇨🇦Verdun, Quebec, Canada
Centre de Recherche Saint-Louis
🇨🇦Quebec, Canada