A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

Korábbi kezelés

• 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
  • Non-biologic, non-targeted systemic immunosuppressants
  • Phototherapy
  • Oral or Topical Janus kinase inhibitors
• Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
  • TCS of any potency
  • TCI
  • Topical phosphodiesterase 4 inhibitors
  • Other topical immunosuppressive agents

• Age ≥ 12 to < 18 years at Day 1.
• 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.
• Body weight ≥ 40 kg at screening.
• History of inadequate response to TCS of medium to higher potency (with or without TCI).
• EASI score ≥ 12 at initial screening.
• EASI score ≥ 16 at Day 1.
• vIGA-AD score ≥ 3.
• ≥10% body surface area of AD involvement.
• Worst pruritus NRS ≥ 4.