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

Launched by AMGEN · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called rocatinlimab, which is being tested for people aged 12 and older who have moderate to severe atopic dermatitis (AD), a skin condition that causes itchy and inflamed skin. The main goal of the study is to see if participants can successfully give themselves the injection of rocatinlimab at home using special devices. To qualify for this study, participants need to have had AD for at least a year, have not responded well to certain treatments like topical corticosteroids, and show specific signs of their skin condition during the screening process.

If you or a family member are considering participating, you should know that the study is currently recruiting participants who meet the age and skin condition criteria. Participants will be able to self-administer the medication, which means they will learn how to give themselves the injection at home. It’s important for potential participants to discuss their medical history with their doctor, as there are certain medications and health conditions that may prevent them from joining the trial. Overall, this study aims to provide new options for managing atopic dermatitis effectively.

Gender

ALL

Eligibility criteria

• 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

Trial Officials