A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

a study on Atopic Dermatitis (Eczema)

Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

The coprimary objectives of the study are 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™).
  • 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).

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)

Keywords

Atopic Dermatitis, AMG 451, Eczema, Rocatinlimab, KHK4083, Dermatitis

Eligibility

You can join if…

Open to people ages 18-100

  • Age ≥ 18 years with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months
  • History of inadequate response to TCS of medium or higher potency (with or without TCI)
  • EASI score ≥16
  • vIGA-AD score ≥3
  • ≥10% body surface area (BSA) of AD involvement
  • Worst pruritus numerical rating scale ≥ 4

You CAN'T join if...

  • 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
    • Nonbiologic, non-targeted Systemic immunosuppressants
    • Phototherapy
    • Janus kinase inhibitors

  • Treatment with any of the following medications or therapies within 1 week, prior to

    Day 1:

    • TCS
    • TCI
    • 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

Locations

  • University of California at Davis Medical Center accepting new patients
    Sacramento California 95816 United States
  • Kaiser Permanente Medical Center - Oakland accepting new patients
    San Francisco California 94118 United States
  • Kaiser Permanente Medical Center - San Francisco accepting new patients
    San Francisco California 94118 United States
  • Synergy Dermatology terminated
    San Francisco California 94132 United States
  • Wallace Medical Group Inc accepting new patients
    Los Angeles California 90056 United States
  • Acclaim Clinical Research accepting new patients
    San Diego California 92120 United States
  • Keck Medicine of University of Southern California accepting new patients
    Los Angeles California 90033 United States
  • Kaiser Permanente South Sacramento Medical Center accepting new patients
    Sacramento California 95823 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT05724199
Phase
Phase 3 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
Expecting 715 study participants
Last Updated