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

Atopic Dermatitis Clinical Trial

— KIND-1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05387707
• Other study ID #: CR845-310501
• Status: Terminated
• Phase: Phase 3
• Start date: August 16, 2022
• Est. completion date: February 2, 2024

Study information

• Verified date: February 2024
• Source: Cara Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Part A of this study includes a 12-week Double-blind Treatment Period and a 52-week Open-label Extension Period. Subjects will be randomized to receive oral difelikefalin 0.25 mg tablets BID plus TCS cream, difelikefalin 0.5 mg tablets BID plus TCS cream, placebo tablets BID plus TCS cream or placebo tablets BID plus vehicle cream. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 287
• Est. completion date: February 2, 2024
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Key Inclusion Criteria:

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. Key Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Pruritus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Cara Therapeutics Study Site	Arlington	Texas
United States	Cara Therapeutics Study Site	Athens	Ohio
United States	Cara Therapeutics Study Site	Auburn Hills	Michigan
United States	Cara Therapeutics Study Site	Austin	Texas
United States	Cara Therapeutics Study Site	Baton Rouge	Louisiana
United States	Cara Therapeutics Study Site	Bellaire	Texas
United States	Cara Therapeutics Study Site	Bexley	Ohio
United States	Cara Therapeutics Study Site	Boardman	Ohio
United States	Cara Therapeutics Study Site	Brandon	Florida
United States	Cara Therapeutics Study Site	Brighton	Massachusetts
United States	Cara Therapeutics Study Site	Charleston	South Carolina
United States	Cara Therapeutics Study Site	Clinton Township	Michigan
United States	Cara Therapeutics Study Site	Coral Gables	Florida
United States	Cara Therapeutics Study Site	Delray Beach	Florida
United States	Cara Therapeutics Study Site	Denver	Colorado
United States	Cara Therapeutics Study Site	Detroit	Michigan
United States	Cara Therapeutics Study Site	Fort Smith	Arkansas
United States	Cara Therapeutics Study Site	Fountain Valley	California
United States	Cara Therapeutics Study Site	Hackensack	New Jersey
United States	Cara Therapeutics Study Site	Hollywood	Florida
United States	Cara Therapeutics Study Site	Houma	Louisiana
United States	Cara Therapeutics Study Site	Houston	Texas
United States	Cara Therapeutics Study Site	Huntersville	North Carolina
United States	Cara Therapeutics Study Site	Indianapolis	Indiana
United States	Cara Therapeutics Study Site	Knoxville	Tennessee
United States	Cara Therapeutics Study Site	Lomita	California
United States	Cara Therapeutics Study Site	Los Angeles	California
United States	Cara Therapeutics Study Site	Louisville	Kentucky
United States	Cara Therapeutics Study Site	Marietta	Georgia
United States	Cara Therapeutics Study Site	Metairie	Louisiana
United States	Cara Therapeutics Study Site	Morgantown	West Virginia
United States	Cara Therapeutics Study Site	New Orleans	Louisiana
United States	Cara Therapeutics Study Site	North Miami Beach	Florida
United States	Cara Therapeutics Study Site	Oklahoma City	Oklahoma
United States	Cara Therapeutics Study Site	Oklahoma City	Oklahoma
United States	Cara Therapeutics Study Site	Orlando	Florida
United States	Cara Therapeutics Study Site	Overland Park	Kansas
United States	Cara Therapeutics Study Site	Philadelphia	Pennsylvania
United States	Cara Therapeutics Study Site	Plainfield	Indiana
United States	Cara Therapeutics Study Site	Plymouth Meeting	Pennsylvania
United States	Cara Therapeutics Study Site	Raleigh	North Carolina
United States	Cara Therapeutics Study Site	Redwood City	California
United States	Cara Therapeutics Study Site	Rockville	Maryland
United States	Cara Therapeutics Study Site	Rogers	Arkansas
United States	Cara Therapeutics Study Site	Sacramento	California
United States	Cara Therapeutics Study Site	Saint Augustine	Florida
United States	Cara Therapeutics Study Site	Saint Petersburg	Florida
United States	Cara Therapeutics Study Site	San Antonio	Texas
United States	Cara Therapeutics Study Site	San Diego	California
United States	Cara Therapeutics Study Site	Santa Monica	California
United States	Cara Therapeutics Study Site 2	Santa Monica	California
United States	Cara Therapeutics Study Site	Scottsdale	Arizona
United States	Cara Therapeutics Study Site	South Bend	Indiana
United States	Cara Therapeutics Study Site	Spokane	Washington
United States	Cara Therapeutics Study Site	Springville	Utah
United States	Cara Therapeutics Study Site	Sugarloaf	Pennsylvania
United States	Cara Therapeutics Study Site	Sweetwater	Florida
United States	Cara Therapeutics Study Site	Tampa	Florida
United States	Cara Therapeutics Study Site	Thompson's Station	Tennessee
United States	Cara Therapeutics Study Site	Valencia	California
United States	Cara Therapeutics Study Site	Waterford	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Cara Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving an improvement from baseline =4 points with respect to the weekly mean of the daily 24-hour I-NRS score at Week 12		Week 12
Secondary	Proportion of subjects achieving = 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 4		Week 4
Secondary	Proportion of subjects with = 3 point improvement from baseline in the weekly mean of the daily 24-hour Sleep Disturbance NRS score at the end of Week 12 (among subjects with a Sleep Disturbance NRS score of > 3 at baseline)		Week 12
Secondary	Proportion of subjects achieving = 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 2		Week 2
Secondary	Proportion of subjects achieving = 4 point improvement from baseline in the weekly mean of the daily 24-hour I-NRS score at Week 1		Week 1
Secondary	Mean change and mean percent change from baseline in EASI score at Week 12.		Week 12
Secondary	Proportion of subjects achieving a vIGA-ADTM score of clear (0) or almost clear (1) with a 2-point improvement from baseline at Week 12 (among subjects with a vIGA-ADTM score = 3 at Day 1)		Week 12
Secondary	Proportion of subjects achieving a vIGA-ADTM score of clear (0) or almost clear (1) with a 2-point improvement from baseline at Week 12 (among subjects with a vIGA-ADTM score = 2 at Day 1)		Week 12
Secondary	Proportion of subjects achieving at least = 3-point improvement in the Skin Pain NRS score at Week 12 (among subjects with a Skin Pain NRS score > 3 at Day 1)		Week 12
Secondary	Proportion of subjects with = 4 point improvement from baseline in Dermatology Life Quality Index (DLQI) score at Week 12 (among subjects with DLQI score > 4 at baseline)		Week 12