A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: January 30, 2023
End Date: April 21, 2025
Inclusion Criteria:
- 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
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
- 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
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Conditions:
- Dermatitis, Atopic
- Dermatitis
- Eczema