A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

• Status: Not yet recruiting
• Trial end date: 2024-10-04
• Target enrollment: 0
• Participant gender: All

Summary

The co-primary objectives of the study are to:

• Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).

• Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: KHK4083

Criteria

Inclusion Criteria:

• Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 6 months

• History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [TCI])

• EASI score ≥16

• vIGA-AD score ≥3

• ≥10% body surface area (BSA) of AD involvement

• Worst pruritus numerical rating scale ≥ 4

Exclusion Criteria:

• Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1

• Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

• Systemic corticosteroids

• Systemic immunosuppressants

• Phototherapy

• Janus kinase inhibitors

• Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

• TCS of any potency

• TCI

• Topical phosphodiesterase type 4 inhibitors

• Other topical immunosuppressive agents