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 (KIND-1)
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 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 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 SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study Site 2Recruiting
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- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Placebo Comparator
Difelikefalin 0.25 mg tablets plus TCS cream
Difelikefalin 0.5 mg tablets plus TCS cream
Placebo tablets plus TCS cream
Placebo tablets plus Vehicle cream (Part A only)
Oral difelikefalin tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed.
Oral difelikefalin tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed.
Oral placebo tablets administered twice daily. TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
Oral placebo tablets administered twice daily. Vehicle cream applied by study subjects to skin lesions once a day until control is achieved, then as needed