A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Registration Number
- NCT06224192
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 151
- 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.
-
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:
- Systemic corticosteroids
- Non-biologic, non-targeted systemic immunosuppressants
- Oral or Topical Janus kinase inhibitors
-
Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:
- Topical phosphodiesterase 4 (PDE4) inhibitors
- Other topical immunosuppressive agents (not including TCS/TCI)
- Combination topical agents containing any of the above components
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of Full-dose Self-administered Rocatinlimab Injections Among Total Attempted Injections up to Week 16 Up to Week 16
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (47)
Kern Research Inc
🇺🇸Bakersfield, California, United States
Long Beach Research Institute
🇺🇸Long Beach, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Havana Research Institute Inc
🇺🇸Pasadena, California, United States
Integrative Skin Science and Research
🇺🇸Sacramento, California, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Anchor Medical Research
🇺🇸Miami, Florida, United States
Hamilton Research, LLC
🇺🇸Alpharetta, Georgia, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Dermatology and Skin Cancer Center Leawood
🇺🇸Leawood, Kansas, United States
Scroll for more (37 remaining)Kern Research Inc🇺🇸Bakersfield, California, United States