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Purpose

The co-primary objectives of the study are to: - Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). - Evaluate the efficacy of rocatinlimab compared with placebo 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 (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months - History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency (with or without topical calcineurin inhibitors [TCI]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks). - 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 - Systemic immunosuppressants - Phototherapy - Oral or topical Janus kinase inhibitors - Treatment with any of the following medications or therapies within 1 week, prior to Day 1: - TCS of any potency - TCI - Topical phosphodiesterase type 4 (PDE4) inhibitors - Other topical immunosuppressive agents - Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Rocatinlimab 		Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
  • Drug: Rocatinlimab
    Rocatinlimab will be administered through a subcutaneous (SC) injection.
    Other names:
    • AMG 451
    • KHK 4083
Placebo Comparator
Placebo 		Placebo Q4W for 24 weeks with a loading dose at Week 2.
  • Other: Placebo
    The matching placebo will be administered through a 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.