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
NCT ID: NCT05387707
Last Updated: 2024-02-22
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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TERMINATED
PHASE3
287 participants
INTERVENTIONAL
2022-08-16
2024-02-02
Brief Summary
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Detailed Description
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Part B of this study includes a 12-week Double-blind Treatment Period and 52-week Open-label Extension Period. Subjects will be randomized to receive oral difelikefalin 0.25 mg or 0.5 mg tablets BID plus TCS cream or oral placebo tablets BID plus TCS cream. Part A results at week 12 will inform Part B.
Subjects who participated in Part A of the study may not participate in Part B.
All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.
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 tablets plus TCS cream
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.
difelikefalin 0.25 mg
Oral difelikefalin 0.25 mg tablets administered twice daily
TCS Cream
TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
Difelikefalin 0.5 mg tablets plus TCS cream
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.
difelikefalin 0.5 mg
Oral difelikefalin 0.5 mg tablets administered twice daily
TCS Cream
TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
Placebo tablets plus TCS cream
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
TCS Cream
TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
Placebo
Oral Placebo tablets administered twice daily
Placebo tablets plus Vehicle cream (Part A only)
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
Placebo
Oral Placebo tablets administered twice daily
Vehicle Cream
Vehicle Cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
Interventions
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difelikefalin 0.25 mg
Oral difelikefalin 0.25 mg tablets administered twice daily
difelikefalin 0.5 mg
Oral difelikefalin 0.5 mg tablets administered twice daily
TCS Cream
TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
Placebo
Oral Placebo tablets administered twice daily
Vehicle Cream
Vehicle Cream applied by study subjects to skin lesions once a day until control is achieved, then as needed
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 chronic pruritus 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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Cara Therapeutics
Role: STUDY_DIRECTOR
Cara Therapeutics
Locations
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Cara Therapeutics Study Site
Scottsdale, Arizona, United States
Cara Therapeutics Study Site
Fort Smith, Arkansas, United States
Cara Therapeutics Study Site
Rogers, Arkansas, United States
Cara Therapeutics Study Site
Fountain Valley, California, United States
Cara Therapeutics Study Site
Lomita, California, United States
Cara Therapeutics Study Site
Los Angeles, California, United States
Cara Therapeutics Study Site
Redwood City, California, United States
Cara Therapeutics Study Site
Sacramento, California, United States
Cara Therapeutics Study Site
San Diego, California, United States
Cara Therapeutics Study Site 2
Santa Monica, California, United States
Cara Therapeutics Study Site
Santa Monica, California, United States
Cara Therapeutics Study Site
Valencia, California, United States
Cara Therapeutics Study Site
Denver, Colorado, United States
Cara Therapeutics Study Site
Brandon, Florida, United States
Cara Therapeutics Study Site
Coral Gables, Florida, United States
Cara Therapeutics Study Site
Delray Beach, Florida, United States
Cara Therapeutics Study Site
Hollywood, Florida, United States
Cara Therapeutics Study Site
North Miami Beach, Florida, United States
Cara Therapeutics Study Site
Orlando, Florida, United States
Cara Therapeutics Study Site
Saint Augustine, Florida, United States
Cara Therapeutics Study Site
St. Petersburg, Florida, United States
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Sweetwater, Florida, United States
Cara Therapeutics Study Site
Tampa, Florida, United States
Cara Therapeutics Study Site
Marietta, Georgia, United States
Cara Therapeutics Study Site
Indianapolis, Indiana, United States
Cara Therapeutics Study Site
Plainfield, Indiana, United States
Cara Therapeutics Study Site
South Bend, Indiana, United States
Cara Therapeutics Study Site
Overland Park, Kansas, United States
Cara Therapeutics Study Site
Louisville, Kentucky, United States
Cara Therapeutics Study Site
Baton Rouge, Louisiana, United States
Cara Therapeutics Study Site
Houma, Louisiana, United States
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Metairie, Louisiana, United States
Cara Therapeutics Study Site
New Orleans, Louisiana, United States
Cara Therapeutics Study Site
Rockville, Maryland, United States
Cara Therapeutics Study Site
Brighton, Massachusetts, United States
Cara Therapeutics Study Site
Auburn Hills, Michigan, United States
Cara Therapeutics Study Site
Clinton Township, Michigan, United States
Cara Therapeutics Study Site
Detroit, Michigan, United States
Cara Therapeutics Study Site
Waterford, Michigan, United States
Cara Therapeutics Study Site
Hackensack, New Jersey, United States
Cara Therapeutics Study Site
Huntersville, North Carolina, United States
Cara Therapeutics Study Site
Raleigh, North Carolina, United States
Cara Therapeutics Study Site
Athens, Ohio, United States
Cara Therapeutics Study Site
Bexley, Ohio, United States
Cara Therapeutics Study Site
Boardman, Ohio, United States
Cara Therapeutics Study Site
Oklahoma City, Oklahoma, United States
Cara Therapeutics Study Site
Oklahoma City, Oklahoma, United States
Cara Therapeutics Study Site
Philadelphia, Pennsylvania, United States
Cara Therapeutics Study Site
Plymouth Meeting, Pennsylvania, United States
Cara Therapeutics Study Site
Sugarloaf, Pennsylvania, United States
Cara Therapeutics Study Site
Charleston, South Carolina, United States
Cara Therapeutics Study Site
Knoxville, Tennessee, United States
Cara Therapeutics Study Site
Thompson's Station, Tennessee, United States
Cara Therapeutics Study Site
Arlington, Texas, United States
Cara Therapeutics Study Site
Austin, Texas, United States
Cara Therapeutics Study Site
Bellaire, Texas, United States
Cara Therapeutics Study Site
Houston, Texas, United States
Cara Therapeutics Study Site
San Antonio, Texas, United States
Cara Therapeutics Study Site
Springville, Utah, United States
Cara Therapeutics Study Site
Spokane, Washington, United States
Cara Therapeutics Study Site
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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CR845-310501
Identifier Type: -
Identifier Source: org_study_id
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