The coprimary objectives of the study are to:

• evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™).
• evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).

Inclusion Criteria:

• Age ≥ 18 years with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months
• History of inadequate response to TCS of medium or higher potency (with or without TCI)
• 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 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
  • Nonbiologic, non-targeted Systemic immunosuppressants
  • Phototherapy
  • Janus kinase inhibitors

• Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

  • TCS
  • TCI
  • Topical phosphodiesterase type 4 inhibitors
  • Other topical immunosuppressive agents
  • Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1)the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.