Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
20210145 Enrolling

Phase 3 Research Trial for Atopic Dermatitis – Eczema 4 (68 Weeks)


Treatment: Injection Age: 12 Years


Recruiting adolescents from 12 to less than 18 years of age with a diagnosis of atopic dermatitis (AD) for at least 6 months for this research trial.  To qualify for the study, individuals must have moderate to severe disease with AD involvement of ≥10% of body surface area.  In addition, eligible participants must have a history of inadequate response to topical corticosteroids (TCS) of medium or 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 (in combination with topical treatment – for combination therapy cohort).  Following re-randomization at Week 24, all participants will receive active study drug.  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 68 weeks and involve about 19 visits to the study centre.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Vipul Jain

allergist

Dr. Charles Lynde

Dermatologist

Dr. Darryl P. Toth

Dermatologist

Dr. Kirsten Walker

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: May 19, 2024

Official Title

A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

ClinicalTrials.gov ID

NCT05704738

Sponsor

Amgen

Study Description

  • Brief Summary:

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

  • Condition or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Drug: Rocatinlimab
    Drug: Rocatinlimab
    Drug: Placebo
    Drug: Rocatinlimab
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    12 Years and 17 Years (Child)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Age ≥ 12 to < 18 years at Day 1. Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent. Body weight ≥ 40 kg at screening. History of inadequate response to TCS of medium to higher potency (with or without TCI). EASI score ≥ 12 at initial screening. EASI score ≥ 16 at Day 1. vIGA-AD score ≥ 3. ≥10% body surface area of AD involvement. Worst pruritus NRS ≥ 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 Non-biologic, non-targeted 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 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.



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