Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

Clinical Trial ID: NCT04018027

Description

This is a multicenter, randomized, double-blind, 4-arm, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with atopic dermatitis (AD) and moderate to severe pruritus.

The study will consist of a 30-day Screening period, a 7-day Run-In period, a 12-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 7 days after the last dose of study drug. All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility. Subjects will be randomized in a 1:1:1:1 ratio to receive either placebo or difelikefalin (CR845) tablets at a dose of 0.25 mg, 0.5 mg, or 1.0 mg, orally BID. Intake of the first dose of study drug will be at Day 1. Subjects who complete the Placebo-Controlled Treatment period of the study will transition into the Active Extension upon completion of the Week 12 visit assessments. All subjects in the Active Extension will receive difelikefalin (CR845).


Criteria

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 at least a 12-month history of AD; - Subject has chronic itch 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.

  • Start Date

    2019-06-29

  • Last Updated

    2019-08-08

  • Sponsor

    Cara Therapeutics, Inc.

  • Condition Name

    Atopic Dermatitis

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