A Two-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate-to-Severe Pruritus in Adult Subjects With Atopic Dermatitis
Status: Terminated
Location: See all (61) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a two-part, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid (TCS) for moderate-to-severe pruritus in adult subjects with atopic dermatitis (AD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
⁃ 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.
Locations
United States
Arkansas
Cara Therapeutics Study Site
Fort Smith
Cara Therapeutics Study Site
Rogers
Arizona
Cara Therapeutics Study Site
Scottsdale
California
Cara Therapeutics Study Site
Fountain Valley
Cara Therapeutics Study Site
Lomita
Cara Therapeutics Study Site
Los Angeles
Cara Therapeutics Study Site
Redwood City
Cara Therapeutics Study Site
Sacramento
Cara Therapeutics Study Site
San Diego
Cara Therapeutics Study Site
Santa Monica
Cara Therapeutics Study Site 2
Santa Monica
Cara Therapeutics Study Site
Valencia
Colorado
Cara Therapeutics Study Site
Denver
Florida
Cara Therapeutics Study Site
Brandon
Cara Therapeutics Study Site
Coral Gables
Cara Therapeutics Study Site
Delray Beach
Cara Therapeutics Study Site
Hollywood
Cara Therapeutics Study Site
North Miami Beach
Cara Therapeutics Study Site
Orlando
Cara Therapeutics Study Site
Saint Augustine
Cara Therapeutics Study Site
St. Petersburg
Cara Therapeutics Study Site
Sweetwater
Cara Therapeutics Study Site
Tampa
Georgia
Cara Therapeutics Study Site
Marietta
Indiana
Cara Therapeutics Study Site
Indianapolis
Cara Therapeutics Study Site
Plainfield
Cara Therapeutics Study Site
South Bend
Kansas
Cara Therapeutics Study Site
Overland Park
Kentucky
Cara Therapeutics Study Site
Louisville
Louisiana
Cara Therapeutics Study Site
Baton Rouge
Cara Therapeutics Study Site
Houma
Cara Therapeutics Study Site
Metairie
Cara Therapeutics Study Site
New Orleans
Massachusetts
Cara Therapeutics Study Site
Brighton
Maryland
Cara Therapeutics Study Site
Rockville
Michigan
Cara Therapeutics Study Site
Auburn Hills
Cara Therapeutics Study Site
Clinton Township
Cara Therapeutics Study Site
Detroit
Cara Therapeutics Study Site
Waterford
North Carolina
Cara Therapeutics Study Site
Huntersville
Cara Therapeutics Study Site
Raleigh
New Jersey
Cara Therapeutics Study Site
Hackensack
Ohio
Cara Therapeutics Study Site
Athens
Cara Therapeutics Study Site
Bexley
Cara Therapeutics Study Site
Boardman
Oklahoma
Cara Therapeutics Study Site
Oklahoma City
Cara Therapeutics Study Site
Oklahoma City
Pennsylvania
Cara Therapeutics Study Site
Philadelphia
Cara Therapeutics Study Site
Plymouth Meeting
Cara Therapeutics Study Site
Sugarloaf
South Carolina
Cara Therapeutics Study Site
Charleston
Tennessee
Cara Therapeutics Study Site
Knoxville
Cara Therapeutics Study Site
Thompson's Station
Texas
Cara Therapeutics Study Site
Arlington
Cara Therapeutics Study Site
Austin
Cara Therapeutics Study Site
Bellaire
Cara Therapeutics Study Site
Houston
Cara Therapeutics Study Site
San Antonio
Utah
Cara Therapeutics Study Site
Springville
Washington
Cara Therapeutics Study Site
Spokane
West Virginia
Cara Therapeutics Study Site
Morgantown
Time Frame
Start Date: 2022-08-16
Completion Date: 2024-02-02
Participants
Target number of participants: 287
Treatments
Experimental: 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.
Experimental: 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.
Active_comparator: 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
Placebo_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Cara Therapeutics, Inc.