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Atopic Dermatitis (ROCKET-Horizon Study)

Study Description

Brief 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).

Condition or Disease

Atopic Dermatitis

Study Design

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title:
A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
Actual Study Start Date: December 14, 2022
Estimated Primary Completion Date: June 28, 2024
Estimated Study Completion Date: September 19, 2024

Eligibility Criteria

Ages Eligible for Study: 18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study: 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
    • 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 inhibitors
    • Other topical immunosuppressive agents
    • Phototherapy
ADDITIONAL DETAILS