A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis

Korábbi kezelés

• Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization.
• Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization:
  • Systemic corticosteroids
  • Non-biologic, non-targeted systemic immunosuppressants
  • Oral or Topical Janus kinase inhibitors
• Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:
  • Topical phosphodiesterase 4 (PDE4) inhibitors
  • Other topical immunosuppressive agents (not including TCS/TCI)
  • Combination topical agents containing any of the above components

• Age ≥ 12 at Day 1.
• Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months.
• History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI]).
• Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3 at screening and pre-randomization.
• Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening and pre-randomization.
• ≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization.