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

Primary Purpose

Pruritus, Notalgia Paresthetica

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
difelikefalin 2.0 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 Notalgia Paresthetica, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, NP, Neuropathic itch

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 Notalgia Paresthetica;
  • Subject has a history of chronic pruritus due to Notalgia Paresthetica;
  • 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 pruritus attributed to a cause other than Notalgia Paresthetica;
  • 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
  • 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
  • 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
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site
  • Cara Therapeutics Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Difelikefalin 2.0 mg

Placebo

Arm Description

Oral difelikefalin 2.0 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 Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8.

Secondary Outcome Measures

Improvement in itch-related quality of life as assessed by the change from baseline to Week 8 in total Skindex-10 Scale score
Change from baseline in itch-related Sleep Disturbance Subscale measured by the Itch Medical Outcomes Study (MOS) at Week 8

Full Information

First Posted
January 11, 2021
Last Updated
May 17, 2023
Sponsor
Cara Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04706975
Brief Title
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)
Official Title
A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Adult Subjects With Notalgia Paresthetica
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
May 18, 2022 (Actual)
Study Completion Date
June 30, 2022 (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, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with notalgia paresthetica and moderate to severe pruritus.
Detailed Description
The study will consist of a 37-day Screening period, a 7-day Run-In period, a 8-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 14 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 2.0 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 period upon completion of the Week 8 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, Notalgia Paresthetica
Keywords
Notalgia Paresthetica, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, NP, Neuropathic itch

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Difelikefalin 2.0 mg
Arm Type
Active Comparator
Arm Description
Oral difelikefalin 2.0 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 2.0 mg
Other Intervention Name(s)
CR845
Intervention Description
Oral difelikefalin 2.0 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 Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Improvement in itch-related quality of life as assessed by the change from baseline to Week 8 in total Skindex-10 Scale score
Time Frame
Baseline, Week 8
Title
Change from baseline in itch-related Sleep Disturbance Subscale measured by the Itch Medical Outcomes Study (MOS) at Week 8
Time Frame
Baseline, Week 8

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 Notalgia Paresthetica; Subject has a history of chronic pruritus due to Notalgia Paresthetica; 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 pruritus attributed to a cause other than Notalgia Paresthetica; 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
Nilam Shah
Organizational Affiliation
Cara Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Cara Therapeutics Study Site
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
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
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cara Therapeutics Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
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
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Cara Therapeutics Study Site
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
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 York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Cara Therapeutics Study Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Cara Therapeutics Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
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
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Cara Therapeutics Study Site
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
Cara Therapeutics Study Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Cara Therapeutics Study Site
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
Cara Therapeutics Study Site
City
Peterborough
State/Province
Ontario
Country
Canada
Facility Name
Cara Therapeutics Study Site
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Cara Therapeutics Study Site
City
Markham
Country
Canada
Facility Name
Cara Therapeutics Study Site
City
Montréal
Country
Canada
Facility Name
Cara Therapeutics Study Site
City
Peterborough
Country
Canada
Facility Name
Cara Therapeutics Study Site
City
Surrey
Country
Canada
Facility Name
Cara Therapeutics Study Site
City
Winnipeg
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 Notalgia Paresthetica (KOMFORT)

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