Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab (AMG 451) in Combination with Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Moderate-to-severe AD (ROCKET-SHUTTLE)

Prior treatment

• Treatment with a biologic immunosuppressive or immunomodulatory therapy for AD or any other autoimmune, inflammatory, or allergic condition (eg, dupilumab, tralokinumab, lebrikizumab, other interleukin-inhibitors, anti-immunoglobulin E [IgE], tumor necrosis factor [TNF] inhibitors) within 12 weeks or 5 halflives, whichever is longer, prior to day 1 prerandomization
• Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization  -Systemic corticosteroids (inhaled corticosteroids, intra-articular steroid injection, eye, ear, or nasal drops containing corticosteroids are allowed, suppositories, or enemas containing corticosteroids are not allowed) - Systemic treatment with methotrexate, mycophenolate, calcineurin inhibitors, or other non-biological, non-targeted systemic immunosuppressants - ​Phototherapy - ​Oral or topical JAK inhibitors
• Treatment with any of the following agents within 1 week before day 1 prerandomization: TCS of any potency TCI Topical PDE4 inhibitors Other topical immunosuppressive agents Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents.

• Prior to informed consent, history of inadequate response to TCS of medium or higher potency (refer to Table 11 4) (with or without TCI as appropriate)
• ​Presence of moderate-to-severe AD at both initial screening and day 1 prerandomization visit, defined as EASI score ≥ 16, vIGA-AD score ≥ 3 and ≥ 10% body surface area (BSA) of AD involvement.  Additionally, patient reported worst pruritus numeric rating scale (NRS) ³ 4 at initial screening.​
• ​​Males or females aged ≥ 18 years with a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria; Eichenfield et al, 2014), that has been present for at least 12 months before the date of informed consent.