Atopic Dermatitis (ROCKET-ASTRO Study)

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent subjects.

Condition or Disease

Atopic Dermatitis

Study Design

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 500 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)
Actual Study Start Date: April 20, 2023
Estimated Primary Completion Date: June 28, 2025
Estimated Study Completion Date: September 18, 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.
  • Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent.
  • Body weight ‚Č• 40 kg at screening.
  • History of inadequate response to TCS of medium to higher potency (with or without TCI).
  • EASI score ‚Č• 12 at initial screening.
  • EASI score ‚Č• 16 at Day 1.
  • vIGA-AD score ‚Č• 3.
  • ‚Č•10% body surface area of AD involvement.
  • Worst pruritus NRS ‚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:
    1. Systemic corticosteroids
    2. Non-biologic, non-targeted systemic immunosuppressants
    3. Phototherapy
    4. Oral or Topical Janus kinase inhibitors
  • Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
    1. TCS of any potency
    2. TCI
    3. Topical phosphodiesterase 4 inhibitors
    4. Other topical immunosuppressive agents
ADDITIONAL DETAILS