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

Primary Purpose

Pruritus, Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
difelikefalin 0.25 mg
difelikefalin 0.5 mg
difelikefalin 1.0 mg
Placebo
Sponsored by
Cara Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus focused on measuring Atopic Dermatitis, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, Eczema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site 2
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site 2
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site 2
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site 2
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Difelikefalin 0.25 mg

Difelikefalin 0.5 mg

Difelikefalin 1.0 mg

Placebo

Arm Description

Oral difelikefalin 0.25 mg tablet administered twice daily

Oral difelikefalin 0.5 mg tablet administered twice daily

Oral difelikefalin 1.0 mg tablet administered twice daily

Oral placebo tablet administered twice daily

Outcomes

Primary Outcome Measures

Change from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 12.

Secondary Outcome Measures

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
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in 5-D Itch Scale score
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in total Skindex-10 Scale score
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in Sleep Quality Assessment.
Percent of subjects with adverse events.

Full Information

First Posted
July 9, 2019
Last Updated
March 30, 2022
Sponsor
Cara Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04018027
Brief Title
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 29, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cara Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Atopic Dermatitis
Keywords
Atopic Dermatitis, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Difelikefalin 0.25 mg
Arm Type
Active Comparator
Arm Description
Oral difelikefalin 0.25 mg tablet administered twice daily
Arm Title
Difelikefalin 0.5 mg
Arm Type
Active Comparator
Arm Description
Oral difelikefalin 0.5 mg tablet administered twice daily
Arm Title
Difelikefalin 1.0 mg
Arm Type
Active Comparator
Arm Description
Oral difelikefalin 1.0 mg tablet administered twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo tablet administered twice daily
Intervention Type
Drug
Intervention Name(s)
difelikefalin 0.25 mg
Other Intervention Name(s)
CR845
Intervention Description
Oral difelikefalin 0.25 mg administered twice daily
Intervention Type
Drug
Intervention Name(s)
difelikefalin 0.5 mg
Other Intervention Name(s)
CR845
Intervention Description
Oral difelikefalin 0.5 mg administered twice daily
Intervention Type
Drug
Intervention Name(s)
difelikefalin 1.0 mg
Other Intervention Name(s)
CR845
Intervention Description
Oral difelikefalin 1.0 mg administered twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Placebo administered twice daily
Primary Outcome Measure Information:
Title
Change from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 12.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
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
Time Frame
Week 12
Title
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in 5-D Itch Scale score
Time Frame
Baseline, Week 12
Title
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in total Skindex-10 Scale score
Time Frame
Baseline, Week 12
Title
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in Sleep Quality Assessment.
Time Frame
Baseline, Week 12
Title
Percent of subjects with adverse events.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Nograles
Organizational Affiliation
Cara Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Cara Therapeutics Study Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Cara Therapeutics Study Site 2
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Cara Therapeutics Study Site 2
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Cara Therapeutics Study Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Cara Therapeutics Study Site 2
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Horseheads
State/Province
New York
ZIP/Postal Code
14845
Country
United States
Facility Name
Cara Therapeutics Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Cara Therapeutics Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Cara Therapeutics Study Site 2
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Cara Therapeutics Study Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Cara Therapeutics Study Site
City
Montréal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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