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

Purpose

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).

Condition

  • Atopic Dermatitis

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

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 - 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Rocatinlimab Dose 1 + TCS/TCI 		Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2.
  • Drug: Rocatinlimab
    Subcutaneous (SC) injection
    Other names:
    • AMG 451
Experimental
Rocatinlimab Dose 2 + TCS/TCI 		Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.
  • Drug: Rocatinlimab
    Subcutaneous (SC) injection
    Other names:
    • AMG 451
Placebo Comparator
Placebo + TCS/TCI 		Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.
  • Other: Placebo
    SC injection

More Details

Status
Completed
Sponsor
Amgen

Study Contact