Atopic Dermatitis (ROCKET-Orbit Study)

Study Description

Brief Summary

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

Condition or Disease

Moderate-to-Severe Atopic Dermatitis

Study Design

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ‚Č• 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
Actual Study Start Date: December 23, 2022
Actual Primary Completion Date: March 14, 2025
Actual Study Completion Date: March 14, 2025

Eligibility Criteria

Ages Eligible for Study:   12 Years to 17 Years (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers: No

Inclusion Criteria

  • Age ‚Č• 12 to < 18 years at day 1.
  • Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 6 months before signing of informed consent
  • History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [TCI])
  • Eczema Area and Severity Index (EASI) score ‚Č• 16
  • vIGA-AD score ‚Č• 3
  • ‚Č• 10% BSA of AD involvement at day 1 pre-enrollment

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 agents within 1 week before day 1 pre-enrollment:
    • TCS
    • TCI
    • Anti-pruritic agents
    • Topical phosphodiesterase type 4 (PDE4) inhibitors
    • Other topical immunosuppressive agents
    • Combination topical agents