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

JRCT ID: jRCT2051240013

Registered date:23/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 24/05/2024
• Target sample size: 100
• Countries of recruitment: Australia,Japan,Canada,Japan,Hong Kong SAR,Japan,Singapore,Japan,South Korea,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Rocatinlimab Dose 1
Rocatinlimab will be self-administered subcutaneously using a prefilled syringe (PFS). Participants will receive rocatinlimab every 4 weeks (Q4W) for 52 weeks with a loading dose at week 2.

Rocatinlimab Dose 2
Rocatinlimab will be self-administered subcutaneously using a prefilled syringe (PFS). Participants will receive rocatinlimab every 4 weeks (Q4W) for 52 weeks with a loading dose at week 2.

Outcome(s)

• Primary Outcome: Proportion of full-dose self-administered rocatinlimab injections as reported by participants or caregivers among attempted home-use injections at weeks 4 and 12 combined
• Secondary Outcome: Proportion of devices that have been reported with Product Complaints by participants, caregivers, or investigators among dispensed home-use devices at weeks 4 and 12 combined

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Chen Sarah
• Secondary ID(s): NCT06224192