Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis
NCT ID: NCT04018027
Last Updated: 2022-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
401 participants
INTERVENTIONAL
2019-06-29
2021-04-01
Brief Summary
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Detailed Description
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All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.
Subjects will be randomized to receive either placebo or difelikefalin (CR845) tablets at a dose of 0.25 mg, 0.5 mg, or 1.0 mg, orally BID. Intake of the first dose of study drug will be at Day 1.
Subjects who complete the Placebo-Controlled Treatment period of the study will transition into the Active Extension upon completion of the Week 12 visit assessments. All subjects in the Active Extension will receive difelikefalin (CR845).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Difelikefalin 0.25 mg
Oral difelikefalin 0.25 mg tablet administered twice daily
difelikefalin 0.25 mg
Oral difelikefalin 0.25 mg administered twice daily
Difelikefalin 0.5 mg
Oral difelikefalin 0.5 mg tablet administered twice daily
difelikefalin 0.5 mg
Oral difelikefalin 0.5 mg administered twice daily
Difelikefalin 1.0 mg
Oral difelikefalin 1.0 mg tablet administered twice daily
difelikefalin 1.0 mg
Oral difelikefalin 1.0 mg administered twice daily
Placebo
Oral placebo tablet administered twice daily
Placebo
Oral Placebo administered twice daily
Interventions
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difelikefalin 0.25 mg
Oral difelikefalin 0.25 mg administered twice daily
difelikefalin 0.5 mg
Oral difelikefalin 0.5 mg administered twice daily
difelikefalin 1.0 mg
Oral difelikefalin 1.0 mg administered twice daily
Placebo
Oral Placebo administered twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Cara Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kristine Nograles
Role: STUDY_DIRECTOR
Cara Therapeutics
Locations
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Cara Therapeutics Study Site
Anniston, Alabama, United States
Cara Therapeutics Study Site
Birmingham, Alabama, United States
Cara Therapeutics Study Site
Scottsdale, Arizona, United States
Cara Therapeutics Study Site
Bryant, Arkansas, United States
Cara Therapeutics Study Site
Fountain Valley, California, United States
Cara Therapeutics Study Site
Lomita, California, United States
Cara Therapeutics Study Site
Cromwell, Connecticut, United States
Cara Therapeutics Study Site
Farmington, Connecticut, United States
Cara Therapeutics Study Site
Aventura, Florida, United States
Cara Therapeutics Study Site 2
Miami, Florida, United States
Cara Therapeutics Study Site
Miami, Florida, United States
Cara Therapeutics Study Site
Miami Lakes, Florida, United States
Cara Therapeutics Study Site
Ocala, Florida, United States
Cara Therapeutics Study Site
Sarasota, Florida, United States
Cara Therapeutics Study Site
Sweetwater, Florida, United States
Cara Therapeutics Study Site
Columbus, Georgia, United States
Cara Therapeutics Study Site
Boise, Idaho, United States
Cara Therapeutics Study Site 2
Boise, Idaho, United States
Cara Therapeutics Study Site
Baton Rouge, Louisiana, United States
Cara Therapeutics Study Site
Metairie, Louisiana, United States
Cara Therapeutics Study Site
New Orleans, Louisiana, United States
Cara Therapeutics Study Site
Brighton, Massachusetts, United States
Cara Therapeutics Study Site 2
Las Vegas, Nevada, United States
Cara Therapeutics Study Site
Berlin, New Jersey, United States
Cara Therapeutics Study Site
Horseheads, New York, United States
Cara Therapeutics Study Site
New York, New York, United States
Cara Therapeutics Study Site
New York, New York, United States
Cara Therapeutics Study Site
Cleveland, Ohio, United States
Cara Therapeutics Study Site
Oklahoma City, Oklahoma, United States
Cara Therapeutics Study Site
Tulsa, Oklahoma, United States
Cara Therapeutics Study Site
Medford, Oregon, United States
Cara Therapeutics Study Site
Rapid City, South Dakota, United States
Cara Therapeutics Study Site 2
Austin, Texas, United States
Cara Therapeutics Study Site
Austin, Texas, United States
Cara Therapeutics Study Site
Cypress, Texas, United States
Cara Therapeutics Study Site
Dallas, Texas, United States
Cara Therapeutics Study Site
Salt Lake City, Utah, United States
Cara Therapeutics Study Site
Richmond, Virginia, United States
Cara Therapeutics Study Site
London, Ontario, Canada
Cara Therapeutics Study Site
Montreal, Quebec, Canada
Countries
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Other Identifiers
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CR845-210501
Identifier Type: -
Identifier Source: org_study_id
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