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

Prior treatment

• 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

• 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