Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis (KARE)
Pruritus, Atopic Dermatitis
About this trial
This is an interventional treatment trial for Pruritus focused on measuring Atopic Dermatitis, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, Eczema
Eligibility 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.
Sites / Locations
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site 2
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site 2
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site 2
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site 2
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
- Cara Therapeutics Study Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Difelikefalin 0.25 mg
Difelikefalin 0.5 mg
Difelikefalin 1.0 mg
Placebo
Oral difelikefalin 0.25 mg tablet administered twice daily
Oral difelikefalin 0.5 mg tablet administered twice daily
Oral difelikefalin 1.0 mg tablet administered twice daily
Oral placebo tablet administered twice daily