Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
20210142 Enrolling

Phase 3 Research Trial for Atopic Dermatitis – Eczema 1 (40 Weeks)


Treatment: Injection Age: 18 Years

Adults aged 18 and over with a diagnosis of atopic dermatitis (AD) for at least 6 months are needed for this research trial.  Eligible candidates must have a history of inadequate response to topical corticosteroids (TCS) of medium or high potency within 6 months, or for whom topical treatments are otherwise medically inadvisable.  In addition, there must be moderate to severe disease with an involvement of eczema on 10% or more of the body surface area (BSA).

Participants will receive an investigational medication (active study drug) or placebo via injection. Study medication and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses may be provided.

Study participation will last about 40 weeks and involve about 11 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: March 19, 2023

Official Title

A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)

ClinicalTrials.gov ID

NCT05398445

Sponsor

Amgen

Study Description

  • Brief Summary:

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

  • Condition or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Drug: AMG 451
    Drug: AMG 451
    Drug: Placebo
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and 100 Years (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 6 months
History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [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
Systemic immunosuppressants
Phototherapy
Janus kinase inhibitors

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

TCS of any potency
TCI
Anti-pruritic drug
Topical phosphodiesterase type 4 inhibitors
Other topical immunosuppressive agents


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations


Participating Experts

Dr. Hermenio Lima

allergist,Dermatologist

Dr. Kirsten Walker

Dermatologist

Dr. Mark Lomaga

Dermatologist

Dr. Maryam Shayesteh Alam

Dermatologist

Dr. David N. Adam

Dermatologist

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