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

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT05899816

Run by

Amgen

People needed

221

Starts

2023-06-07

Expected to finish

2024-11-14

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 54. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• 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
• Affiliated Dermatology — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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