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:
INCLUSION 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 chronic pruritus related to AD;
- Subject has moderate to severe pruritus;
- Female subject is not pregnant or nursing during any period of the study.
EXCLUSION CRITERIA
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.
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
Contition
Pruritus,Atopic Dermatitis
Age (in years)
18 - 80
Phase
Phase 3
Participants needed
280
Est. Completion Date
Feb 28, 2026
Treatment type
Interventional
Sponsor
Cara Therapeutics, Inc.
ClinicalTrials.gov identifier
NCT05387707
Study number
CR845-310501
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