A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis
NCT ID: NCT06224192
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
151 participants
INTERVENTIONAL
2024-04-02
2026-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rocatinlimab Dose 1 Prefilled Syringe (PFS)
Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.
Rocatinlimab Prefilled Syringe
Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab.
Rocatinlimab Dose 2 PFS
Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.
Rocatinlimab Prefilled Syringe
Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab.
Rocatinlimab Dose 2 Autoinjector (AI)
Rocatinlimab will be self-administered subcutaneously using an AI. Participants will received rocatinlimab for 52 weeks.
Rocatinlimab AI
AI for SC injection self-administration of rocatinlimab.
Interventions
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Rocatinlimab Prefilled Syringe
Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab.
Rocatinlimab AI
AI for SC injection self-administration of rocatinlimab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
12 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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, Fukuoka, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Matsuo Clinic
Fukuoka, Fukuoka, Japan
Suizenji Dermatology Clinic
Kumamoto, 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, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon-si, Gyeonggi-do, , South Korea
Countries
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References
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Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20230180
Identifier Type: -
Identifier Source: org_study_id
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