For Healthcare Professionals

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis


About the study

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).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Key Inclusion Criteria:

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

  1. Subject has clinically confirmed diagnosis of active AD;
  2. Subject has chronic pruritus related to AD;
  3. Subject has moderate to severe pruritus;
  4. 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:

  1. Subject has clinically infected AD;
  2. Subject has pruritus attributed to a cause other than AD;
  3. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Pruritus,Atopic Dermatitis

Age (in years)

18 - 80


Phase 3

Participants needed


Est. Completion Date

Feb 28, 2026

Treatment type



Cara Therapeutics, Inc. identifier


Study number


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