Status:
TERMINATED
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
Lead Sponsor:
Cara Therapeutics, Inc.
Conditions:
Pruritus
Atopic Dermatitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 pr...
Detailed Description
Part A of this study includes a 12-week Double-blind Treatment Period and a 52-week Open-label Extension Period. Subjects will be randomized to receive oral difelikefalin 0.25 mg tablets BID plus TCS ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
August 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2024
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT05387707
Start Date
August 16 2022
End Date
February 2 2024
Last Update
February 22 2024
Active Locations (61)
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1
Cara Therapeutics Study Site
Scottsdale, Arizona, United States, 85260
2
Cara Therapeutics Study Site
Fort Smith, Arkansas, United States, 72916
3
Cara Therapeutics Study Site
Rogers, Arkansas, United States, 72758
4
Cara Therapeutics Study Site
Fountain Valley, California, United States, 92708