Overview
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.
Eligibility
Inclusion Criteria:
- Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
- History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency within 6 months (with or without topical calcineurin inhibitors [TCI]).
- EASI score ≥16
- vIGA-AD score ≥3
- ≥10% body surface area (BSA) of AD involvement
- Worst pruritus numerical rating scale ≥ 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:
- Systemic corticosteroids
- Systemic immunosuppressants
- Phototherapy
- 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 type 4 inhibitors
- Other topical immunosuppressive agents