Overview

A Study Evaluating AMG 451 in Moderate To-severe Atopic Dermatitis (ROCKET-IGNITE)

Status:
Not yet recruiting
Trial end date:
2025-01-05
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of AMG 451 in monotherapy treatment.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
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

- Anti-pruritic agents

- Phototherapy

- Janus kinase inhibitors

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

- TCS

- TCI

- Topical phosphodiesterase type 4 inhibitors

- Other topical immunosuppressive agents