Atopic Dermatitis (ROCKET-SHUTTLE Study)

Study Description

Brief Summary

The coprimary objectives of the study are to:

  • To evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD).
  • To evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI 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: 715 participants
Allocation: Randomized
Intervention Model: Sequential 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) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
Actual Study Start Date: February 21, 2023
Estimated Primary Completion Date: September 20, 2024
Estimated Study Completion Date: December 12, 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 ‚Č• 18 years with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 6 months
  • History of inadequate response to TCS of medium or higher potency within 6 months (with or without TCI)
  • EASI score ‚Č•16
  • vIGA-AD score ‚Č•3
  • ‚Č•10% body surface area (BSA) of AD involvement
  • Worst pruritus numerical rating scale ‚Č• 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
    • TCI
    • Anti-pruritic agents
    • Topical phosphodiesterase type 4 inhibitors
    • Other topical immunosuppressive agents
    • Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents
ADDITIONAL DETAILS