A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe AD
- Conditions
- Atopic Dermatitis
- Interventions
- Combination Product: Rocatinlimab AICombination Product: Rocatinlimab Prefilled Syringe
- Registration Number
- NCT06224192
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneous using devices for injection at home.
- 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
- Arm && Interventions
Group Intervention Description Rocatinlimab Dose 2 Autoinjector (AI) Rocatinlimab AI Rocatinlimab will be self-administered subcutaneously using an AI. Participants will received rocatinlimab for 52 weeks. Rocatinlimab Dose 1 Prefilled Syringe (PFS) Rocatinlimab Prefilled Syringe Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks. Rocatinlimab Dose 2 PFS Rocatinlimab Prefilled Syringe Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.
- Primary Outcome Measures
Name Time Method Proportion of Full-dose Self-administered Rocatinlimab Injections Among Attempted Home-use 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 Home-use 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
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
Las Vegas Clinical Trials
🇺🇸North Las Vegas, Nevada, United States
Skin Cancer and Dermatology Institute
🇺🇸Reno, Nevada, United States
The Skin Surgery Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Bexley Dermatology Research
🇺🇸Bexley, Ohio, United States
Apex Clinical Research Center LLC
🇺🇸Mayfield Heights, Ohio, United States
Essential Medical Research LLC
🇺🇸Tulsa, Oklahoma, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Cumberland Skin Center
🇺🇸Hermitage, Tennessee, United States
Sms Clinical Research Limited Liability Company
🇺🇸Mesquite, Texas, United States
Texas Dermatology Research Center
🇺🇸Plano, Texas, United States
Virginia Dermatology and Skin Cancer Center
🇺🇸Norfolk, Virginia, United States
Interior Dermatology Centre
🇨🇦Kelowna, British Columbia, Canada
LEADER Research
🇨🇦Hamilton, Ontario, Canada
Lynderm Research Inc
🇨🇦Markham, Ontario, Canada
DermEdge Research Incorporated
🇨🇦Mississauga, Ontario, Canada
Allergy Research Canada Incorporated
🇨🇦Niagara Falls, Ontario, Canada
North Bay Dermatology Centre
🇨🇦North Bay, Ontario, Canada
Dermatology Ottawa Research Centre
🇨🇦Ottawa, Ontario, Canada
FACET Dermatology
🇨🇦Toronto, Ontario, Canada
Alliance Clinical Trials
🇨🇦Waterloo, Ontario, Canada
XLR8 Medical Research, Incorporated
🇨🇦Windsor, Ontario, Canada
Skinsense Medical Research
🇨🇦Saskatoon, Saskatchewan, Canada
Ekihigashi Dermatology Allergy Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
Fukuoka University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Matsuo Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
Suizenji Dermatology Clinic
🇯🇵Kumamoto-shi, Kumamoto, Japan
Dermatology and Ophthalmology Kume Clinic
🇯🇵Sakai-shi, Osaka, Japan
Mita Dermatology Clinic
🇯🇵Minato-ku, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Korea University Ansan Hospital
🇰🇷Ansan-si, Gyeonggi-do, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St Marys Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of