Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
CR845-310501

Atopic Dermatitis – Eczema Research Trial (70-72 Weeks)


Treatment: Oral Age: 18 Years


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

Official Title

A Two-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate-to-Severe Pruritus in Adult Subjects With Atopic Dermatitis

ClinicalTrials.gov ID

NCT05387707

Sponsor

Cara Therapeutics, Inc.

Study Description

  • Brief Summary:

    This is a two-part, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid (TCS) for moderate-to-severe pruritus in adult subjects with atopic dermatitis (AD).

  • Condition or Disease:

    Pruritus

  • Intervention/Treatment:

    Drug: difelikefalin 0.25 mg
    Drug: difelikefalin 0.5 mg
    Drug: TCS Cream
    Drug: Placebo
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and 80 Years (Adult)

  • Sexes Eligible for Study:

    All

Key Inclusion Criteria:

To be eligible for inclusion into the study, a patient must meet the following criteria:

Subject has clinically confirmed diagnosis of active AD;
Subject has chronic pruritus related to AD;
Subject has moderate to severe pruritus;
Female subject is not pregnant or nursing during any period of the study.

Key Exclusion Criteria:

A patient will be excluded from the study if any of the following criteria are met:

Subject has clinically infected AD;
Subject has pruritus attributed to a cause other than AD;
Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.


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

COUNTRY
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United States

Participating Experts

Dr. Matthew Zirwas

Dermatologist

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