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

Inclusion Criteria:

• Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 yearsat signing of informed consent) with a diagnosis of AD according to the AADConsensus Criteria (2014) present for at least 12 months

• History of inadequate response to TCS (Topical Corticosteroid) of medium or higherpotency (with or without topical calcineurin inhibitors [TCI]) as appropriate or forwhom topical treatments are otherwise medically inadvisable (eg, because ofimportant 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

Exclusion Criteria:

• Treatment with a biological product within 12 weeks or 5 half-lives, whichever islonger, prior to Day 1

• Treatment with any of the following medications or therapies within 4 weeks or 5half-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 toDay 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, orother immunosuppressive agents