Clinical trial NCT05899816: A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
Official title: A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of Rocatinlimab on Vaccine Antibody Response in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Moderate-to-severe Atopic Dermatitis
Keywords: Moderate-to-severe Atopic Dermatitis
AD
Rocatinlimab
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants with a Positive Anti-tetanus Response
timeFrame: Week 20 to week 24
measure: Number of Participants with a Positive Anti-meningococcal Response
timeFrame: Week 20 to week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Affiliated Dermatology
state: Arizona
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Tempe
country: United States
facility: Medical Advancement Centers of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Allergy and Asthma Clinical Research Center
state: Arkansas
city: Bakersfield
country: United States
facility: Kern Research Inc
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research LLC
state: California
city: Chino
country: United States
facility: Doc1 Healthcare Systems
state: California
city: Inglewood
country: United States
facility: 310 Clinical Research
state: California
city: Lancaster
country: United States
facility: Chemidox Clinical Trials Incorporated
state: California
city: Long Beach
country: United States
facility: Long Beach Research Institute
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group Inc
state: California
city: Los Angeles
country: United States
facility: West Los Angeles Clinical Trials
state: California
city: Northridge
country: United States
facility: Northridge Clinical Trials
state: California
city: Pasadena
country: United States
facility: Havana Research Institute Inc
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: San Diego
country: United States
facility: Wake Research Medical Center for Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Cura Clinical Research
state: California
city: Tustin
country: United States
facility: Wolverine Clinical Trials
state: California
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research
state: Florida
city: Coral Springs
country: United States
facility: Life Clinical Trials
state: Florida
city: Destin
country: United States
facility: AllerVie Clinical Research- Destin
state: Florida
city: Doral
country: United States
facility: D and H Doral Research Centers
state: Florida
city: Doral
country: United States
facility: Saint Jude Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Homestead
country: United States
facility: Nexus Clinical Research
state: Florida
city: Miami Gardens
country: United States
facility: Meridian International Research
state: Florida
city: Miami
country: United States
facility: D and H National Research Centers
state: Florida
city: Miami
country: United States
facility: Gold Coast Health Research Center
state: Florida
city: Miami
country: United States
facility: Anchor Medical Research
state: Florida
city: Ocala
country: United States
facility: AllerVie Clinical Research- Ocala
state: Florida
city: Tamarac
country: United States
facility: D and H Tamarac Research Centers
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Research, LLC
state: Georgia
city: Atlanta
country: United States
facility: Divine Dermatology and Aesthetics
state: Georgia
city: Atlanta
country: United States
facility: MetroDerm / Atlanta Center for Clinical Research, LLC
state: Georgia
city: Fayetteville
country: United States
facility: First Georgia Physicians Group
state: Georgia
city: Macon
country: United States
facility: Dermatologic Surgery Specialists
state: Georgia
city: Thomasville
country: United States
facility: McIntosh Clinic PC
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: New Albany
country: United States
facility: Southern Indiana Clinical Trials
state: Indiana
city: Leawood
country: United States
facility: Dermatology and Skin Cancer Center Leawood
state: Kansas
city: Largo
country: United States
facility: Visage Dermatology and Aesthetic Center
state: Maryland
city: Methuen
country: United States
facility: ActivMed Practices and Research, LLC
state: Massachusetts
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology
state: Michigan
city: Caledonia
country: United States
facility: The Derm Institute of West Michigan
state: Michigan
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: Pioneer Clinical Research New York
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research Inc
state: New York
city: Hickory
country: United States
facility: Hickory Dermatology Research Center
state: North Carolina
city: Matthews
country: United States
facility: Tryon Medical Partners
state: North Carolina
city: Winston-Salem
country: United States
facility: The Skin Surgery Center
state: North Carolina
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center LLC
state: Ohio
city: Springfield
country: United States
facility: Dermatologist of Central States Clinical Research - Springfield
state: Ohio
city: Chickasha
country: United States
facility: Epic Medical Research - Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Dermatology Research Center of Oklahoma, PLLC
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research Inc
state: Oregon
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Hermitage
country: United States
facility: Cumberland Skin Center
state: Tennessee
city: Houston
country: United States
facility: MedCare Pharma - Houston
state: Texas
city: Mesquite
country: United States
facility: sms Clinical Research Limited Liability Company
state: Texas
city: Southlake
country: United States
facility: Stryde Research - Epiphany Dermatology
state: Texas
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Texas
city: Bountiful
country: United States
facility: Cope Family Medicine
state: Utah
city: Murray
country: United States
facility: Tanner Clinic
state: Utah
city: Edmonton
country: Canada
facility: Skin Physicians Dermatology
state: Alberta
city: Kelowna
country: Canada
facility: Interior Dermatology Centre
state: British Columbia
city: Saint John's
country: Canada
facility: Karma Clinical Trials
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Skincare Studio
state: Newfoundland and Labrador
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: Guelph
country: Canada
facility: Guelph Dermatology Research
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Centre
state: Ontario
city: Toronto
country: Canada
facility: FACET Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Evidence Based Medical Educator Inc
state: Ontario
city: Toronto
country: Canada
facility: DermAtelier Clinical Research Incorporated
state: Ontario
city: Montreal
country: Canada
facility: Clinique de Dermatologie Rosemont
state: Quebec
city: Verdun
country: Canada
facility: Sima recherche
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: