A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

Purpose

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).

Condition

  • Atopic Dermatitis

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months - History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency (with or without topical calcineurin inhibitors [TCI]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks). - 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 - Oral or topical 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 (PDE4) inhibitors - Other topical immunosuppressive agents - Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Rocatinlimab 		Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
  • Drug: Rocatinlimab
    Rocatinlimab will be administered through a subcutaneous (SC) injection.
    Other names:
    • AMG 451
    • KHK 4083
Placebo Comparator
Placebo 		Placebo Q4W for 24 weeks with a loading dose at Week 2.
  • Other: Placebo
    The matching placebo will be administered through a SC injection.

More Details

Status
Completed
Sponsor
Amgen

Study Contact