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Completed

NCT Number: NCT06224192

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

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

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Key information

Age range

12 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Interior Dermatology Centre, Kelowna, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

Rocatinlimab prefilled syringe

Combination Product

Prefilled Syringe (PFS) for subcutaneous (SC) injection self-administration of rocatinlimab.

Other names: AMG 451

Rocatinlimab AI

Combination Product

AI for SC injection self-administration of rocatinlimab.

Other names: AMG 451

Primary outcomes

  1. Proportion of Full-dose Self-administered Rocatinlimab Injections Among Total Attempted Injections up to Week 16

    Time frame: Up to Week 16

Secondary outcomes

  1. 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

    Time frame: Up to Week 16

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Open-label, Performance Study With Self-administered Subcutaneous Rocatinlimab (AMG 451) in Adolescent and Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Outpost)

Acronym: ROCKET-Outpost

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 25, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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