A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis

Completed · Phase 3

Conditions studied: Atopic Dermatitis

In brief

The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.

Key facts

Study ID

NCT06224192

Run by

Amgen

People needed

151

Starts

2024-04-02

Expected to finish

2026-03-16

Last updated by the study team

2026-03-25

Who can join

Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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