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

Open to people ages 12-17

• 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.

• 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:
  1. Systemic corticosteroids
  2. Non-biologic, non-targeted systemic immunosuppressants
  3. Phototherapy
  4. Oral or Topical Janus kinase inhibitors

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

  Day 1:

  1. TCS of any potency
  2. TCI
  3. Topical phosphodiesterase 4 inhibitors
  4. Other topical immunosuppressive agents