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

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  12 and up

Participation Criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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:

1. Systemic corticosteroids
2. Non-biologic, non-targeted systemic immunosuppressants
3. Oral or Topical Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:

1. Topical phosphodiesterase 4 (PDE4) inhibitors
2. Other topical immunosuppressive agents (not including TCS/TCI)
3. Combination topical agents containing any of the above components