NCT05387707 - 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 | Biotech Hunter

Enrollment

287

Participants

Timeline

Start Date

August 16, 2022

Primary Completion Date

February 2, 2024

Study Completion Date

February 2, 2024

Conditions

PruritusAtopic Dermatitis

Interventions

DRUG

difelikefalin 0.25 mg

Oral difelikefalin 0.25 mg tablets administered twice daily

DRUG

difelikefalin 0.5 mg

Oral difelikefalin 0.5 mg tablets administered twice daily

DRUG

TCS Cream

TCS cream applied by study subjects to skin lesions once a day until control is achieved, then as needed

DRUG

Placebo

Oral Placebo tablets administered twice daily

DRUG

Vehicle Cream

Vehicle Cream applied by study subjects to skin lesions once a day until control is achieved, then as needed

Trial Locations (61)

18249

Cara Therapeutics Study Site, Sugarloaf

19103

Cara Therapeutics Study Site, Philadelphia

19462

Cara Therapeutics Study Site, Plymouth Meeting

20850

Cara Therapeutics Study Site, Rockville

26505

Cara Therapeutics Study Site, Morgantown

27617

Cara Therapeutics Study Site, Raleigh

28078

Cara Therapeutics Study Site, Huntersville

29407

Cara Therapeutics Study Site, Charleston

30060

Cara Therapeutics Study Site, Marietta

32080

Cara Therapeutics Study Site, Saint Augustine

32819

Cara Therapeutics Study Site, Orlando

33021

Cara Therapeutics Study Site, Hollywood

33134

Cara Therapeutics Study Site, Coral Gables

33162

Cara Therapeutics Study Site, North Miami Beach

33172

Cara Therapeutics Study Site, Sweetwater

33484

Cara Therapeutics Study Site, Delray Beach

33511

Cara Therapeutics Study Site, Brandon

33607

Cara Therapeutics Study Site, Tampa

33709

Cara Therapeutics Study Site, St. Petersburg

37179

Cara Therapeutics Study Site, Thompson's Station

37909

Cara Therapeutics Study Site, Knoxville

40241

Cara Therapeutics Study Site, Louisville

43209

Cara Therapeutics Study Site, Bexley

44512

Cara Therapeutics Study Site, Boardman

45701

Cara Therapeutics Study Site, Athens

46168

Cara Therapeutics Study Site, Plainfield

46250

Cara Therapeutics Study Site, Indianapolis

46617

Cara Therapeutics Study Site, South Bend

48038

Cara Therapeutics Study Site, Clinton Township

48202

Cara Therapeutics Study Site, Detroit

48326

Cara Therapeutics Study Site, Auburn Hills

48328

Cara Therapeutics Study Site, Waterford

66210

Cara Therapeutics Study Site, Overland Park

70006

Cara Therapeutics Study Site, Metairie

70115

Cara Therapeutics Study Site, New Orleans

70364

Cara Therapeutics Study Site, Houma

70809

Cara Therapeutics Study Site, Baton Rouge

72758

Cara Therapeutics Study Site, Rogers

72916

Cara Therapeutics Study Site, Fort Smith

73118

Cara Therapeutics Study Site, Oklahoma City

73170

Cara Therapeutics Study Site, Oklahoma City

76011

Cara Therapeutics Study Site, Arlington

77004

Cara Therapeutics Study Site, Houston

77401

Cara Therapeutics Study Site, Bellaire

78209

Cara Therapeutics Study Site, San Antonio

78759

Cara Therapeutics Study Site, Austin

80210

Cara Therapeutics Study Site, Denver

84663

Cara Therapeutics Study Site, Springville

85260

Cara Therapeutics Study Site, Scottsdale

90033

Cara Therapeutics Study Site, Los Angeles

90404

Cara Therapeutics Study Site 2, Santa Monica

Cara Therapeutics Study Site, Santa Monica

90717

Cara Therapeutics Study Site, Lomita

91355

Cara Therapeutics Study Site, Valencia

92123

Cara Therapeutics Study Site, San Diego

92708

Cara Therapeutics Study Site, Fountain Valley

94063

Cara Therapeutics Study Site, Redwood City

95815

Cara Therapeutics Study Site, Sacramento

99202

Cara Therapeutics Study Site, Spokane

02135

Cara Therapeutics Study Site, Brighton

07601

Cara Therapeutics Study Site, Hackensack