A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-VOYAGER)
Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis
About this trial
This is an interventional basic science trial for Atopic Dermatitis focused on measuring Moderate-to-severe Atopic Dermatitis, AD, Rocatinlimab
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 or higher potency (with or without topical calcineurin inhibitors) 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 Topical calcineurin inhibitors (TCI) Anti-pruritic agents or antihistamines used for treatment of pruritis 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. Inactivated vaccination (eg, non-live or nonreplicating agent), including coronavirus disease 2019 (COVID-19) vaccination, is allowed. 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
Sites / Locations
- Affiliated DermatologyRecruiting
- Little Rock Allergy and Asthma Clinical Research CenterRecruiting
- Kern Research IncRecruiting
- Hope Clinical Research LLCRecruiting
- Chemidox Clinical Trials IncorporatedRecruiting
- Long Beach Research Institute, LLCRecruiting
- Wallace Medical Group, IncRecruiting
- Peninsula Research AssociatesRecruiting
- Integrative Skin Science and ResearchRecruiting
- Wolverine Clinical TrialsRecruiting
- Cura Clinical ResearchRecruiting
- Life Clinical TrialsRecruiting
- D and H Doral Research CentersRecruiting
- Meridian International ResearchRecruiting
- Gold Coast Health Research CenterRecruiting
- Anchor Medical ResearchRecruiting
- Dermatologic Surgery SpecialistsRecruiting
- Visage Dermatology and Aesthetic CenterRecruiting
- Excel Clinical ResearchRecruiting
- Skin Cancer and Dermatology InstituteRecruiting
- The Skin Surgery CenterRecruiting
- Apex DermatologyRecruiting
- Oregon Dermatology and Research CenterRecruiting
- Cumberland Skin CenterRecruiting
- Sms Clinical Research Limited Liability CompanyRecruiting
- Tranquil Clinical ResearchRecruiting
- York Dermatology CentreRecruiting
- FACET DermatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Rocatinlimab
Placebo
During the 24-week treatment period, the participants will receive rocatinlimab once every 4 weeks (Q4W) for 24 weeks with a loading dose given at Week 2.
During the 24-week treatment period, the participants will receive placebo Q4W for 24 weeks with a loading dose given at Week 2.