20230180 Enrolling

Clinical Trial for Adolescents and Adults with Atopic Dermatitis (68 Weeks)


Treatment: Injection Age: 12 Years


Who Can Participate?

People aged 12 and above diagnosed with atopic dermatitis may participate.

 

Inclusion Criteria

  • Diagnosis of atopic dermatitis that has been present for at least 12 months.
  • Body weight ≥ 40 kg (88lbs)
  • History of inadequate response to topical corticosteroid (TCS) treatment of medium to higher potency) or for whom topical treatments are otherwise medically inadvisable.

 

What Are the Benefits?

  • The study-required procedures and investigational drug will be provided at no cost to qualified participants.
  • Regular visits with study doctors who specialize in treating skin diseases (about 10 visits at the research site).

 

How Long Will the Study Last?

  • Around 68 weeks

Participating Locations

COUNTRY
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Canada
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United States

Participating Experts

No Doctors Found

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The following information is from ClinicalTrials.gov

Last Update Posted: May 14, 2024

Official Title

A Phase 3, Multicenter, Randomized, Open-label, Performance Study With Self-administered Subcutaneous Rocatinlimab (AMG 451) in Adolescent and Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Outpost)

ClinicalTrials.gov ID

NCT06224192

Sponsor

Amgen

Study Description

  • Brief Summary:

    The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneous using devices for injection at home.

  • Condition or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Combination Product: Rocatinlimab Prefilled Syringe Combination Product: Rocatinlimab Prefilled Syringe
  • Phase:

    PHASE3

  • Ages Eligible for Study:

    12 Years and 100 Years (CHILD,ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL

Inclusion Criteria

  • Diagnosis of atopic dermatitis that has been present for at least 12 months.
  • Body weight ≥ 40 kg (88lbs)
  • History of inadequate response to topical corticosteroid (TCS) treatment of medium to higher potency) or for whom topical treatments are otherwise medically inadvisable.

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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ECZEMA - ATOPIC DERMATITIS

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