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

November 3, 2025 updated by: Amgen

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6W 4V4
        • Skin Physicians Dermatology
    • British Columbia
      • Kelowna, British Columbia, Canada, V1W 4V5
        • Interior Dermatology Centre
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1E 1V4
        • Skincare Studio
      • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
        • Karma Clinical Trials
    • Ontario
      • Etobicoke, Ontario, Canada, M8X 1Y9
        • Kingsway Clinical Research
      • Guelph, Ontario, Canada, N1L 0B7
        • Guelph Dermatology Research
      • Richmond Hill, Ontario, Canada, L4C 9M7
        • York Dermatology Centre
      • Toronto, Ontario, Canada, M5G 1E2
        • Evidence Based Medical Educator Inc
      • Toronto, Ontario, Canada, M5M 3Z8
        • DermAtelier Clinical Research Incorporated
      • Toronto, Ontario, Canada, M4E 1R7
        • FACET Dermatology
    • Quebec
      • Montreal, Quebec, Canada, H1Y 3L1
        • Clinique de Dermatologie Rosemont
      • Québec, Quebec, Canada, G1W 4R4
        • Centre de Recherche Saint-Louis
      • Verdun, Quebec, Canada, H4G 3E7
        • SIMa Recherche
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Center for Dermatology and Plastic Surgery
      • Scottsdale, Arizona, United States, 85260
        • Scottsdale Clinical Trials
      • Scottsdale, Arizona, United States, 85255
        • Affiliated Dermatology
      • Tempe, Arizona, United States, 85283
        • Medical Advancement Centers of Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Allergy and Asthma Clinical Research Center
    • California
      • Bakersfield, California, United States, 93301
        • Kern Research Inc
      • Canoga Park, California, United States, 91303
        • Hope clinical Research LLC
      • Chino, California, United States, 91710
        • Doc1 Healthcare Systems
      • Inglewood, California, United States, 90301
        • 310 Clinical Research
      • Lancaster, California, United States, 93534
        • Chemidox Clinical Trials Incorporated
      • Long Beach, California, United States, 90805
        • Long Beach Research Institute
      • Los Angeles, California, United States, 90024
        • University of California Los Angeles
      • Los Angeles, California, United States, 90056
        • Wallace Medical Group Inc
      • Los Angeles, California, United States, 90067
        • West Los Angeles Clinical Trials
      • Northridge, California, United States, 91325
        • Northridge Clinical Trials
      • Pasadena, California, United States, 91105
        • Havana Research Institute Inc
      • Rolling Hills Estates, California, United States, 90274
        • Peninsula Research Associates
      • Sacramento, California, United States, 95815
        • Integrative Skin Science and Research
      • San Diego, California, United States, 92120
        • Wake Research Medical Center for Clinical Research
      • Sherman Oaks, California, United States, 91403
        • Cura Clinical Research
      • Tustin, California, United States, 92780
        • Wolverine Clinical Trials
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Alliance for Multispecialty Research
      • Coral Springs, Florida, United States, 33071
        • Life Clinical Trials
      • Destin, Florida, United States, 32541
        • AllerVie Clinical Research- Destin
      • Doral, Florida, United States, 33172
        • Saint Jude Clinical Research
      • Doral, Florida, United States, 33122
        • D and H Doral Research Centers
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Research Center
      • Homestead, Florida, United States, 33033
        • Nexus Clinical Research
      • Miami, Florida, United States, 33155
        • D and H National Research Centers
      • Miami, Florida, United States, 33155
        • Gold Coast Health Research Center
      • Miami, Florida, United States, 33176
        • Anchor Medical Research
      • Miami Gardens, Florida, United States, 33014
        • Meridian International Research
      • Ocala, Florida, United States, 34471
        • AllerVie Clinical Research- Ocala
      • Tamarac, Florida, United States, 33321
        • D and H Tamarac Research Centers
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Hamilton Research, LLC
      • Atlanta, Georgia, United States, 30315
        • Divine Dermatology and Aesthetics
      • Atlanta, Georgia, United States, 30342
        • MetroDerm / Atlanta Center for Clinical Research, LLC
      • Fayetteville, Georgia, United States, 30214
        • First Georgia Physicians Group
      • Macon, Georgia, United States, 31217
        • Dermatologic Surgery Specialists
      • Thomasville, Georgia, United States, 31792
        • McIntosh Clinic PC
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
      • New Albany, Indiana, United States, 47150
        • Southern Indiana Clinical trials
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Dermatology and Skin Cancer Center Leawood
    • Maryland
      • Largo, Maryland, United States, 20774
        • Visage Dermatology and Aesthetic Center
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices and Research, LLC
    • Michigan
      • Auburn Hills, Michigan, United States, 48326
        • Oakland Hills Dermatology
      • Caledonia, Michigan, United States, 49316
        • The Derm Institute of West Michigan
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research
      • North Las Vegas, Nevada, United States, 89030
        • Las Vegas Clinical Trials
      • Reno, Nevada, United States, 89509
        • Skin Cancer and Dermatology Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
    • New York
      • Kew Gardens, New York, United States, 11415
        • Forest Hills Dermatology Group
      • New York, New York, United States, 10016
        • Pioneer Clinical Research New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research Inc
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Hickory Dermatology Research Center
      • Matthews, North Carolina, United States, 28105
        • Tryon Medical Partners
      • Winston-Salem, North Carolina, United States, 27103
        • The Skin Surgery Center
    • Ohio
      • Mayfield Heights, Ohio, United States, 44124
        • Apex Clinical Research Center LLC
      • Springfield, Ohio, United States, 45505
        • Dermatologist of Central States Clinical Research - Springfield
    • Oklahoma
      • Chickasha, Oklahoma, United States, 73018
        • Epic Medical Research - Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Unity Clinical Research
      • Tulsa, Oklahoma, United States, 74132
        • Dermatology Research Center of Oklahoma, PLLC
    • Oregon
      • Medford, Oregon, United States, 97504
        • Velocity Clinical Research Inc
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Hermitage, Tennessee, United States, 37076
        • Cumberland Skin Center
    • Texas
      • Houston, Texas, United States, 77037
        • MedCare Pharma - Houston
      • Mesquite, Texas, United States, 75149
        • Sms Clinical Research Limited Liability Company
      • Southlake, Texas, United States, 76092
        • Stryde Research - Epiphany Dermatology
      • Webster, Texas, United States, 77598
        • Tranquil Clinical Research
    • Utah
      • Bountiful, Utah, United States, 84010
        • Cope Family Medicine
      • Murray, Utah, United States, 84107
        • Tanner Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rocatinlimab
Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Drug: Rocatinlimab
Subcutaneous (SC) injection
Other Names:
  • AMG 451
  • KHK4083
Placebo Comparator: Placebo
Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Drug: Placebo
SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with a Positive Anti-tetanus Response
Time Frame: Week 20 to week 24
Week 20 to week 24
Number of Participants with a Positive Anti-meningococcal Response
Time Frame: Week 20 to week 24
Week 20 to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2023

Primary Completion (Actual)

August 26, 2024

Study Completion (Actual)

November 14, 2024

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Estimated)

November 5, 2025

Last Update Submitted That Met QC Criteria

November 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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