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


Cara Therapeutics, Inc.
NCT ID: NCT04018027
Last Updated: August 8, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 2
  • Gender: All
  • Age: 18 Years - 80 Years
  • Condition:
    • Pruritus
    • Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Cara Therapeutics, Inc.
  • Location: Not Provided

Official Title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Adult Subjects With Atopic Dermatitis

Purpose

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.

Eligibility

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Cara Therapeutics, Inc.

Investigators

Study Director: Kristine Nograles

Cara Therapeutics

Please refer to this study by its ClinicalTrials.gov identifier: NCT04018027

Location

Contacts

Cara Therapeutics Study Site

Boise, Idaho 83704

United States

Cara Therapeutics Study Site

Berlin, New Jersey 08009

United States

Cara Therapeutics Study Site

Tulsa, Oklahoma 74136

United States