A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab 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
  • Systemic immunosuppressants
  • Phototherapy
  • Oral or topical janus kinase inhibitors
• Treatment with any of the following agents within 1 week before day 1 pre-enrollment:
  • Topical PDE4 inhibitors
  • Other topical immunosuppressive agents (not including TCS/TCI)
  • Combination topical agents containing a high- or super-high potency corticosteroid

• Age ≥ 12 to < 18 years at day 1.
• Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 12 months before signing of informed consent
• Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
• Eczema Area and Severity Index (EASI) score ≥ 12
• vIGA-AD score ≥ 3
• ≥ 10% BSA of AD involvement at day 1 pre-enrollment