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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.