A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab Monotherapy in Moderate-to-severe AD (ROCKET-Ignite)

Prior treatment

• Treatment with a biological immunosuppressive or immunomodulatory therapy for AD or any other autoimmune, inflammatory, or allergic condition within 12 weeks or 5 half lives, 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/mycophenolate mofetil, calcineurin inhibitors, thalidomide, or other non-biologic, non-targeted systemic immunosuppressants -Phototherapy -Oral or topical JAK inhibitors
• Treatment with any of the following agents within 1 week before day 1 prerandomization: -Topical phosphodiesterase type 4 (PDE4) inhibitors -Other topical immunosuppressive agents -Combination topical agents including PDE4 inhibitors, or other topical immunosuppressive agents

• Males or females aged ≥ 18 years or legal adult age within subject’s country, whichever is older, 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 signing of informed consent.
• Prior to informed consent, history of inadequate response or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
• Presence of moderate-to-severe AD at both initial screening and day 1 prerandomization visit, defined as EASI score ≥ 16, vIGA-AD score ≥ 3 (on the 0 to 4 vIGA-AD scale, in which 3 is moderate and 4 is severe) and ≥ 10% body surface area (BSA) of AD involvement. Additionally, patient-reported worst pruritus NRS >/= 4 based on a single-question item with 7-day recall is required at initial screening.