Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— KARE  

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Adult Subjects With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018027
• Other study ID #: CR845-210501
• Status: Completed
• Phase: Phase 2
• Start date: June 29, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: March 2022
• Source: Cara Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, 4-arm, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with atopic dermatitis (AD) and moderate to severe pruritus.

Description:

The study will consist of a 30-day Screening period, a 7-day Run-In period, a 12-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 7 days after the last dose of study drug.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• 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 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.

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 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

Locations

Country	Name	City	State
Canada	Cara Therapeutics Study Site	London	Ontario
Canada	Cara Therapeutics Study Site	Montréal	Quebec
United States	Cara Therapeutics Study Site	Anniston	Alabama
United States	Cara Therapeutics Study Site	Austin	Texas
United States	Cara Therapeutics Study Site 2	Austin	Texas
United States	Cara Therapeutics Study Site	Aventura	Florida
United States	Cara Therapeutics Study Site	Baton Rouge	Louisiana
United States	Cara Therapeutics Study Site	Berlin	New Jersey
United States	Cara Therapeutics Study Site	Birmingham	Alabama
United States	Cara Therapeutics Study Site	Boise	Idaho
United States	Cara Therapeutics Study Site 2	Boise	Idaho
United States	Cara Therapeutics Study Site	Brighton	Massachusetts
United States	Cara Therapeutics Study Site	Bryant	Arkansas
United States	Cara Therapeutics Study Site	Cleveland	Ohio
United States	Cara Therapeutics Study Site	Columbus	Georgia
United States	Cara Therapeutics Study Site	Cromwell	Connecticut
United States	Cara Therapeutics Study Site	Cypress	Texas
United States	Cara Therapeutics Study Site	Dallas	Texas
United States	Cara Therapeutics Study Site	Farmington	Connecticut
United States	Cara Therapeutics Study Site	Fountain Valley	California
United States	Cara Therapeutics Study Site	Horseheads	New York
United States	Cara Therapeutics Study Site 2	Las Vegas	Nevada
United States	Cara Therapeutics Study Site	Lomita	California
United States	Cara Therapeutics Study Site	Medford	Oregon
United States	Cara Therapeutics Study Site	Metairie	Louisiana
United States	Cara Therapeutics Study Site	Miami	Florida
United States	Cara Therapeutics Study Site 2	Miami	Florida
United States	Cara Therapeutics Study Site	Miami Lakes	Florida
United States	Cara Therapeutics Study Site	New Orleans	Louisiana
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	Ocala	Florida
United States	Cara Therapeutics Study Site	Oklahoma City	Oklahoma
United States	Cara Therapeutics Study Site	Rapid City	South Dakota
United States	Cara Therapeutics Study Site	Richmond	Virginia
United States	Cara Therapeutics Study Site	Salt Lake City	Utah
United States	Cara Therapeutics Study Site	Sarasota	Florida
United States	Cara Therapeutics Study Site	Scottsdale	Arizona
United States	Cara Therapeutics Study Site	Sweetwater	Florida
United States	Cara Therapeutics Study Site	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Cara Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 12.		Baseline, Week 12
Secondary	Reduction of itch intensity as assessed by the 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	Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in 5-D Itch Scale score		Baseline, Week 12
Secondary	Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in total Skindex-10 Scale score		Baseline, Week 12
Secondary	Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in Sleep Quality Assessment.		Baseline, Week 12
Secondary	Percent of subjects with adverse events.		Baseline, Week 12