Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) 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:
PHASE2
Brief Summary
This is a multicenter, randomized, double-blind, 4-arm, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with atopic derma...
Detailed Description
The study will consist of a 30-day Screening period, a 7-day Run-In period, a 12-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximate...
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 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
- 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 :
June 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT04018027
Start Date
June 29 2019
End Date
April 1 2021
Last Update
April 4 2022
Active Locations (40)
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1
Cara Therapeutics Study Site
Anniston, Alabama, United States, 36207
2
Cara Therapeutics Study Site
Birmingham, Alabama, United States, 35209
3
Cara Therapeutics Study Site
Scottsdale, Arizona, United States, 85254
4
Cara Therapeutics Study Site
Bryant, Arkansas, United States, 72022