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

NCT05899816 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 20210158
• Study Type: interventional
• Target: 221
• Locations: 2 countries
• Sites: 85

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

Conditions

Atopic Dermatitis; Moderate-to-severe Atopic Dermatitis

Keywords

Moderate-to-severe Atopic Dermatitis; AD; Rocatinlimab

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Rocatinlimab

EXPERIMENTAL

Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

Drug: Rocatinlimab

Placebo

PLACEBO COMPARATOR

Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

Drug: Placebo

Interventions

Rocatinlimab DRUG

Subcutaneous (SC) injection

Also known as: AMG 451, KHK4083

Rocatinlimab

Placebo DRUG

SC injection

Placebo

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (85)

Affiliated Dermatology

Scottsdale, Arizona, 85255, United States

Location

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona, 85260, United States

Location

Scottsdale Clinical Trials

Scottsdale, Arizona, 85260, United States

Location

Medical Advancement Centers of Arizona

Tempe, Arizona, 85283, United States

Location

Little Rock Allergy and Asthma Clinical Research Center

Little Rock, Arkansas, 72205, United States

Location

Kern Research Inc

Bakersfield, California, 93301, United States

Location

Hope Clinical Research LLC

Canoga Park, California, 91303, United States

Location

Doc1 Healthcare Systems

Chino, California, 91710, United States

Location

310 Clinical Research

Inglewood, California, 90301, United States

Location

Chemidox Clinical Trials Incorporated

Lancaster, California, 93534, United States

Location

Long Beach Research Institute

Long Beach, California, 90805, United States

Location

University of California Los Angeles

Los Angeles, California, 90024, United States

Location

Wallace Medical Group Inc

Los Angeles, California, 90056, United States

Location

West Los Angeles Clinical Trials

Los Angeles, California, 90067, United States

Location

Northridge Clinical Trials

Northridge, California, 91325, United States

Location

Havana Research Institute Inc

Pasadena, California, 91105, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Wake Research Medical Center for Clinical Research

San Diego, California, 92120, United States

Location

Cura Clinical Research

Sherman Oaks, California, 91403, United States

Location

Wolverine Clinical Trials

Tustin, California, 92780, United States

Location

Alliance for Multispecialty Research

Coral Gables, Florida, 33134, United States

Location

Life Clinical Trials

Coral Springs, Florida, 33071, United States

Location

AllerVie Clinical Research- Destin

Destin, Florida, 32541, United States

Location

D and H Doral Research Centers

Doral, Florida, 33122, United States

Location

Saint Jude Clinical Research

Doral, Florida, 33172, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Nexus Clinical Research

Homestead, Florida, 33033, United States

Location

D and H National Research Centers

Miami, Florida, 33155, United States

Location

Gold Coast Health Research Center

Miami, Florida, 33155, United States

Location

Anchor Medical Research

Miami, Florida, 33176, United States

Location

Meridian International Research

Miami Gardens, Florida, 33014, United States

Location

AllerVie Clinical Research- Ocala

Ocala, Florida, 34471, United States

Location

D and H Tamarac Research Centers

Tamarac, Florida, 33321, United States

Location

Hamilton Research, LLC

Alpharetta, Georgia, 30022, United States

Location

Divine Dermatology and Aesthetics

Atlanta, Georgia, 30315, United States

Location

MetroDerm / Atlanta Center for Clinical Research, LLC

Atlanta, Georgia, 30342, United States

Location

First Georgia Physicians Group

Fayetteville, Georgia, 30214, United States

Location

Dermatologic Surgery Specialists

Macon, Georgia, 31217, United States

Location

McIntosh Clinic PC

Thomasville, Georgia, 31792, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Southern Indiana Clinical Trials

New Albany, Indiana, 47150, United States

Location

Dermatology and Skin Cancer Center Leawood

Leawood, Kansas, 66211, United States

Location

Visage Dermatology and Aesthetic Center

Largo, Maryland, 20774, United States

Location

ActivMed Practices and Research, LLC

Methuen, Massachusetts, 01844, United States

Location

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

Location

The Derm Institute of West Michigan

Caledonia, Michigan, 49316, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030, United States

Location

Skin Cancer and Dermatology Institute

Reno, Nevada, 89509, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

Forest Hills Dermatology Group

Kew Gardens, New York, 11415, United States

Location

Pioneer Clinical Research New York

New York, New York, 10016, United States

Location

Rochester Clinical Research Inc

Rochester, New York, 14609, United States

Location

Hickory Dermatology Research Center

Hickory, North Carolina, 28602, United States

Location

Tryon Medical Partners

Matthews, North Carolina, 28105, United States

Location

The Skin Surgery Center

Winston-Salem, North Carolina, 27103, United States

Location

Apex Clinical Research Center LLC

Mayfield Heights, Ohio, 44124, United States

Location

Dermatologist of Central States Clinical Research - Springfield

Springfield, Ohio, 45505, United States

Location

Epic Medical Research - Oklahoma

Chickasha, Oklahoma, 73018, United States

Location

Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States

Location

Dermatology Research Center of Oklahoma, PLLC

Tulsa, Oklahoma, 74132, United States

Location

Velocity Clinical Research Inc

Medford, Oregon, 97504, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Cumberland Skin Center

Hermitage, Tennessee, 37076, United States

Location

MedCare Pharma - Houston

Houston, Texas, 77037, United States

Location

sms Clinical Research Limited Liability Company

Mesquite, Texas, 75149, United States

Location

Stryde Research - Epiphany Dermatology

Southlake, Texas, 76092, United States

Location

Tranquil Clinical Research

Webster, Texas, 77598, United States

Location

Cope Family Medicine

Bountiful, Utah, 84010, United States

Location

Tanner Clinic

Murray, Utah, 84107, United States

Location

Skin Physicians Dermatology

Edmonton, Alberta, T6W 4V4, Canada

Location

Interior Dermatology Centre

Kelowna, British Columbia, V1W 4V5, Canada

Location

Karma Clinical Trials

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

Skincare Studio

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

Location

Kingsway Clinical Research

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Guelph Dermatology Research

Guelph, Ontario, N1L 0B7, Canada

Location

York Dermatology Centre

Richmond Hill, Ontario, L4C 9M7, Canada

Location

FACET Dermatology

Toronto, Ontario, M4E 1R7, Canada

Location

Evidence Based Medical Educator Inc

Toronto, Ontario, M5G 1E2, Canada

Location

DermAtelier Clinical Research Incorporated

Toronto, Ontario, M5M 3Z8, Canada

Location

Clinique de Dermatologie Rosemont

Montreal, Quebec, H1Y 3L1, Canada

Location

Centre de Recherche Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

Sima recherche

Verdun, Quebec, H4G 3E7, Canada

Location

Related Publications (1)

• 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.

  PMID: 40012373 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

KHK4083

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: June 7, 2023
• Primary Completion: August 26, 2024
• Study Completion: November 14, 2024
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

CA (13); US (72)