Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
20210144 Enrolling

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


Treatment: Injection,Topical Age: 18 Years


Seeking adults aged 18 and over with a diagnosis of atopic dermatitis (AD) for at least 6 months for this research trial.  To qualify for the study, individuals must have AD involvement of ≥10% body surface area, and moderate to severe disease.  Eligible participants must also have a history of inadequate response to topical corticosteroids (TCS) of medium or higher potency within 6 months.

Participants will receive an investigational medication (active study drug) or placebo via injection, in combination with topical treatment.  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 Experts

Dr. Lorne Albrecht

Dermatologist

Dr. Benjamin Barankin

Dermatologist

Dr. Jennifer Beecker

Dermatologist

Dr. Alim Devani

Dermatologist

Dr. Victoria Farley

Dermatologist

Dr. Michael Freeman

Dermatologist

Dr. Anatoli Freiman

Dermatologist

Dr. Melinda Gooderham

Dermatologist

Dr. Vipul Jain

allergist

Dr. Firouzeh Niakosari

Dermatologist

Dr. Kim Alexander Papp

Dermatologist

Dr. Marisa Ponzo

Dermatologist

Dr. Vimal Prajapati

Dermatologist

Dr. Mani Raman

Dermatologist

Dr. Jaggi Rao

Dermatologist

Dr. Michael R. Robern

Dermatologist

Dr. Les A. Rosoph

Dermatologist

Dr. Maxwell Sauder

Dermatologist

Dr. Sanjay Siddha

Dermatologist

Dr. Marni Wiseman

Dermatologist

Dr. Matthew Zirwas

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: May 19, 2024

Official Title

A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)

ClinicalTrials.gov ID

NCT05724199

Sponsor

Amgen

Study Description

  • Brief Summary:

    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 or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Drug: Rocatinlimab
    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 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


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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