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

Overview

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent subjects.

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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