Atopic Dermatitis
Conditions
Brief summary
The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.
Interventions
COMBINATION_PRODUCTRocatinlimab Prefilled Syringe
Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab.
COMBINATION_PRODUCTRocatinlimab AI
AI for SC injection self-administration of rocatinlimab.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Full-dose Self-administered Rocatinlimab Injections Among Total Attempted Injections up to Week 16 | Up to Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Devices that Have Been Reported with Product Complaints Related to Function by Participants, Caregivers, or Investigators Among Total Dispensed Devices up to Week 16 | Up to Week 16 |
Countries
Canada, Japan, South Korea, United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed