A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

Prior treatment

• Treatment with a biological 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
  • Oral or topical Janus kinase inhibitors
• Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
  • TCS of any potency
  • TCI
  • Topical phosphodiesterase type 4 (PDE4) inhibitors
  • Other topical immunosuppressive agents
  • Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents

• Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
• History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency (with or without topical calcineurin inhibitors \[TCI\]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
• EASI score ≥16
• vIGA-AD score ≥3
• ≥10% body surface area (BSA) of AD involvement
• Worst pruritus numerical rating scale ≥ 4