A Phase 3, Open-label Study Assessing Self-administered Rocatinlimab (AMG 451) in Subjects With Moderate-to-severe AD

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051240013

Enrollment

150

Registered

2024-04-23

Start date

2024-09-07

Completion date

Unknown

Last updated

2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Interventions

Rocatinlimab Dose 1 Prefilled Syringe (PFS) Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52. Rocatinlimab Dose 2 PFS Rocatinlimab will

Eligibility

Sex/Gender

All

Inclusion 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. -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

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

Design outcomes

Primary

Measure	Time frame
Proportion of Full-dose Self-administered Rocatinlimab Injections Among Attempted Home-use Injections up to Week 16	—

Secondary

Measure	Time frame
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	—

Countries

Canada, Japan, South Korea, United States

Contacts

Public ContactClinical trial information contact

Kyowa Kirin Co., Ltd.

clinical.info.jp@kyowakirin.com+81-3-5205-7200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026