Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
20210143 Enrolling

Phase 3 Research Trial for Atopic Dermatitis – Eczema 2 (40 Weeks)


Treatment: Injection Age: 18 Years


Adults aged 18 and over with a diagnosis of atopic dermatitis (AD) that has been present for at least 6 months, are needed for a research trial.  To qualify for the study, individuals must have moderate to severe eczema with involvement of 10% or more body surface area (BSA), and a history of inadequate response to topical corticosteroids (TCS) of medium to higher potency within 6 months, or for whom topical treatments are otherwise medically inadvisable.

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 will be provided.

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


Participating Locations

COUNTRY
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United States
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Australia
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Canada

Participating Experts

Dr. Alison Ehrlich

Dermatologist

Dr. Marnie Fisher

Dermatologist

Dr. Peter Foley

Dermatologist

Dr. Melinda Gooderham

Dermatologist

Dr. Sameh Hanna

Dermatologist

Dr. Chih-ho Hong

Dermatologist

Dr. Esther Hong

Dermatologist

Dr. Charles Lynde

Dermatologist

Dr. Andrei Metelitsa

Dermatologist

Dr. Susan Poelman

Dermatologist

Dr. Elena Poulos

Dermatologist

Dr. Mani Raman

Dermatologist

Dr. Sheetal Sapra

Dermatologist

Dr. G. Daniel Schachter

Dermatologist

Dr. Stephen Shumack

Dermatologist

Dr. Darryl P. Toth

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: September 24, 2023

Official Title

A Phase 3, Randomized, 24-week, 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) (ROCKET-Horizon)

ClinicalTrials.gov ID

NCT05651711

Sponsor

Amgen

Study Description

  • Brief Summary:

    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 or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Drug: Rocatinlimab
    Other: Placebo
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and 100 Years (Adult)

  • Sexes Eligible for Study:

    All

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
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 inhibitors
Other topical immunosuppressive agents
Phototherapy


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.



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