A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

Last updated: February 4, 2025
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Eczema (Atopic Dermatitis)

Hives (Urticaria)

Rash

Treatment

Placebo

Rocatinlimab

Clinical Study ID

NCT05899816
20210158
  • Ages 18-54
  • All Genders

Study 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

Inclusion Criteria:

  • Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academyof Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months

  • History of inadequate response to topical corticosteroids (TCS) of medium, high, orhigher potency (with or without topical calcineurin inhibitors)

  • Subjects with previous systemic treatment for AD are also considered as inadequateresponders to topical treatments and are potentially eligible to be included in thestudy after appropriate washout.

  • Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3

Exclusion

Exclusion Criteria:

  • Treatment with a biologic product within 12 weeks or 5 half-lives, whichever islonger, prior to Day 1

  • Treatment with any of the following medications or therapies within 4 weeks or 5half-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 toDay 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 calcineurininhibiting component, PDE4 inhibitors, or other topical immunosuppressiveagents

  • Treatment with live virus including live attenuated vaccination 12 weeks prior today 1 pre-randomization.

  • Treatment with any meningococcal vaccine within 1 year prior to screening, ortreatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5years prior to screening

Study Design

Total Participants: 221
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 07, 2023
Estimated Completion Date:
November 14, 2024

Connect with a study center

  • Skin Physicians Dermatology

    Edmonton, Alberta T6W 4V4
    Canada

    Site Not Available

  • Interior Dermatology Centre

    Kelowna, British Columbia V1W 4V5
    Canada

    Site Not Available

  • Karma Clinical Trials

    Saint John's, Newfoundland and Labrador A1A 4Y3
    Canada

    Site Not Available

  • Skincare Studio

    St. John's, Newfoundland and Labrador A1E 1V4
    Canada

    Site Not Available

  • Kingsway Clinical Research

    Etobicoke, Ontario M8X 1Y9
    Canada

    Site Not Available

  • Guelph Dermatology Research

    Guelph, Ontario N1L 0B7
    Canada

    Site Not Available

  • York Dermatology Centre

    Richmond Hill, Ontario L4C 9M7
    Canada

    Site Not Available

  • DermAtelier Clinical Research Inc.

    Toronto, Ontario M5M 3Z8
    Canada

    Active - Recruiting

  • DermAtelier Clinical Research Incorporated

    Toronto, Ontario M5M 3Z8
    Canada

    Site Not Available

  • Evidence Based Medical Educator Inc

    Toronto, Ontario M5G 1E2
    Canada

    Site Not Available

  • FACET Dermatology

    Toronto, Ontario M4E 1R7
    Canada

    Site Not Available

  • Clinique de Dermatologie Rosemont

    Montreal, Quebec H1Y 3L1
    Canada

    Site Not Available

  • Sima recherche

    Verdun, Quebec H4G 3E7
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • Affiliated Dermatology

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Center for Dermatology and Plastic Surgery

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Scottsdale Clinical Trials

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Medical Advancement Centers of Arizona

    Tempe, Arizona 85283
    United States

    Site Not Available

  • Little Rock Allergy and Asthma Clinical Research Center

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Kern Research Inc

    Bakersfield, California 93301
    United States

    Site Not Available

  • Hope Clinical Research LLC

    Canoga Park, California 91303
    United States

    Site Not Available

  • Doc1 Healthcare Systems

    Chino, California 91710
    United States

    Site Not Available

  • 310 Clinical Research

    Inglewood, California 90301
    United States

    Site Not Available

  • Chemidox Clinical Trials Incorporated

    Lancaster, California 93534
    United States

    Site Not Available

  • Long Beach Research Institute

    Long Beach, California 90805
    United States

    Site Not Available

  • Long Beach Research Institute, LLC

    Long Beach, California 90805
    United States

    Active - Recruiting

  • University of California Los Angeles

    Los Angeles, California 90024
    United States

    Site Not Available

  • Wallace Medical Group Inc

    Los Angeles, California 90056
    United States

    Site Not Available

  • Wallace Medical Group, Inc

    Los Angeles, California 90056
    United States

    Active - Recruiting

  • West Los Angeles Clinical Trials

    Los Angeles, California 90067
    United States

    Site Not Available

  • Northridge Clinical Trials

    Northridge, California 91325
    United States

    Site Not Available

  • Havana Research Institute Inc

    Pasadena, California 91105
    United States

    Site Not Available

  • Peninsula Research Associates

    Rolling Hills Estates, California 90274
    United States

    Site Not Available

  • Integrative Skin Science and Research

    Sacramento, California 95815
    United States

    Site Not Available

  • Wake Research Medical Center for Clinical Research

    San Diego, California 92120
    United States

    Site Not Available

  • Wolverine Clinical Trials

    Santa Ana, California 92705
    United States

    Site Not Available

  • Cura Clinical Research

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Wolverine Clinical Trials

    Tustin, California 92780
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Life Clinical Trials

    Coral Springs, Florida 33071
    United States

    Site Not Available

  • AllerVie Clinical Research- Destin

    Destin, Florida 32541
    United States

    Site Not Available

  • D and H Doral Research Centers

    Doral, Florida 33122
    United States

    Site Not Available

  • Saint Jude Clinical Research

    Doral, Florida 33172
    United States

    Site Not Available

  • Direct Helpers Research Center

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Nexus Clinical Research

    Homestead, Florida 33033
    United States

    Site Not Available

  • Anchor Medical Research

    Miami, Florida 33176
    United States

    Site Not Available

  • D and H National Research Centers

    Miami, Florida 33155
    United States

    Site Not Available

  • Gold Coast Health Research Center

    Miami, Florida 33155
    United States

    Site Not Available

  • Meridian International Research

    Miami Gardens, Florida 33014
    United States

    Site Not Available

  • AllerVie Clinical Research- Ocala

    Ocala, Florida 34471
    United States

    Site Not Available

  • D and H Tamarac Research Centers

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Hamilton Research, LLC

    Alpharetta, Georgia 30022
    United States

    Site Not Available

  • Divine Dermatology and Aesthetics

    Atlanta, Georgia 30315
    United States

    Site Not Available

  • MetroDerm / Atlanta Center for Clinical Research, LLC

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • First Georgia Physicians Group

    Fayetteville, Georgia 30214
    United States

    Site Not Available

  • Dermatologic Surgery Specialists

    Macon, Georgia 31217
    United States

    Site Not Available

  • McIntosh Clinic PC

    Thomasville, Georgia 31792
    United States

    Site Not Available

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Southern Indiana Clinical Trials

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Dermatology and Skin Cancer Center Leawood

    Leawood, Kansas 66211
    United States

    Site Not Available

  • AllerVie Clinical Research- Glenn Dale

    Glenn Dale, Maryland 20769
    United States

    Site Not Available

  • Visage Dermatology and Aesthetic Center

    Largo, Maryland 20774
    United States

    Site Not Available

  • ActivMed Practices and Research, LLC

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Oakland Hills Dermatology

    Auburn Hills, Michigan 48326
    United States

    Site Not Available

  • The Derm Institute of West Michigan

    Caledonia, Michigan 49316
    United States

    Site Not Available

  • Excel Clinical Research

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada 89030
    United States

    Site Not Available

  • Skin Cancer and Dermatology Institute

    Reno, Nevada 89509
    United States

    Site Not Available

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Forest Hills Dermatology Group

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Pioneer Clinical Research New York

    New York, New York 10016
    United States

    Site Not Available

  • Rochester Clinical Research Inc

    Rochester, New York 14609
    United States

    Site Not Available

  • Hickory Dermatology Research Center

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Tryon Medical Partners

    Matthews, North Carolina 28105
    United States

    Site Not Available

  • The Skin Surgery Center

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Apex Clinical Research Center LLC

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Apex Dermatology

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

  • Dermatologist of Central States Clinical Research - Springfield

    Springfield, Ohio 45505
    United States

    Site Not Available

  • Epic Medical Research - Oklahoma

    Chickasha, Oklahoma 73018
    United States

    Site Not Available

  • Unity Clinical Research

    Oklahoma City, Oklahoma 73118
    United States

    Site Not Available

  • Dermatology Research Center of Oklahoma, PLLC

    Tulsa, Oklahoma 74132
    United States

    Site Not Available

  • Velocity Clinical Research Inc

    Medford, Oregon 97504
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Cumberland Skin Center

    Hermitage, Tennessee 37076
    United States

    Site Not Available

  • MedCare Pharma - Houston

    Houston, Texas 77037
    United States

    Site Not Available

  • sms Clinical Research Limited Liability Company

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Stryde Research - Epiphany Dermatology

    Southlake, Texas 76092
    United States

    Site Not Available

  • Tranquil Clinical Research

    Webster, Texas 77598
    United States

    Site Not Available

  • Cope Family Medicine

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Tanner Clinic

    Murray, Utah 84107
    United States

    Site Not Available

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