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

Sponsor

Cara Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04706975

Collaborator

(none)

126

Enrollment

Locations

Arms

17.6

Actual Duration (Months)

3.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pruritus Notalgia Paresthetica	Drug: difelikefalin 2.0 mg Drug: Placebo	Phase 2

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 11, 2021

Actual Primary Completion Date :

May 18, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Difelikefalin 2.0 mg Oral difelikefalin 2.0 mg tablet administered twice daily	Drug: difelikefalin 2.0 mg Oral difelikefalin 2.0 mg administered twice daily Other Names: CR845
Placebo Comparator: Placebo Oral placebo tablet administered twice daily	Drug: Placebo Oral Placebo administered twice daily

Arm

Intervention/Treatment

Active Comparator: Difelikefalin 2.0 mg

Oral difelikefalin 2.0 mg tablet administered twice daily

Drug: difelikefalin 2.0 mg

Oral difelikefalin 2.0 mg administered twice daily

Other Names:

CR845

Placebo Comparator: Placebo

Oral placebo tablet administered twice daily

Drug: Placebo

Oral Placebo administered twice daily

Outcome Measures

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. [Baseline, 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 [Baseline, Week 8]
Change from baseline in itch-related Sleep Disturbance Subscale measured by the Itch Medical Outcomes Study (MOS) at Week 8 [Baseline, Week 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cara Therapeutics Study Site	Fort Smith	Arkansas	United States	72916
2	Cara Therapeutics Study Site	Hot Springs	Arkansas	United States	71913
3	Cara Therapeutics Study Site	Rogers	Arkansas	United States	72758
4	Cara Therapeutics Study Site	Fountain Valley	California	United States	92708
5	Cara Therapeutics Study Site	Los Angeles	California	United States	90033
6	Cara Therapeutics Study Site	San Diego	California	United States	92122
7	Cara Therapeutics Study Site	Santa Monica	California	United States	90404
8	Cara Therapeutics Study Site	Cromwell	Connecticut	United States	06416
9	Cara Therapeutics Study Site	Coral Gables	Florida	United States	33134
10	Cara Therapeutics Study Site	Margate	Florida	United States	33063
11	Cara Therapeutics Study Site	Miami	Florida	United States	33144
12	Cara Therapeutics Study Site	North Miami Beach	Florida	United States	33162
13	Cara Therapeutics Study Site	Sandy Springs	Georgia	United States	30328
14	Cara Therapeutics Study Site	Indianapolis	Indiana	United States	46250
15	Cara Therapeutics Study Site	Plainfield	Indiana	United States	46168
16	Cara Therapeutics Study Site	Metairie	Louisiana	United States	70006
17	Cara Therapeutics Study Site	New York	New York	United States	10029
18	Cara Therapeutics Study Site	High Point	North Carolina	United States	27262
19	Cara Therapeutics Study Site	Columbus	Ohio	United States	43215
20	Cara Therapeutics Study Site	Charleston	South Carolina	United States	29407
21	Cara Therapeutics Study Site	Bellaire	Texas	United States	77401
22	Cara Therapeutics Study Site	Pflugerville	Texas	United States	78660
23	Cara Therapeutics Study Site	San Antonio	Texas	United States	78213
24	Cara Therapeutics Study Site	Salt Lake City	Utah	United States	84117
25	Cara Therapeutics Study Site	Norfolk	Virginia	United States	23502
26	Cara Therapeutics Study Site	Spokane	Washington	United States	99202
27	Cara Therapeutics Study Site	Surrey	British Columbia	Canada
28	Cara Therapeutics Study Site	Winnipeg	Manitoba	Canada
29	Cara Therapeutics Study Site	Markham	Ontario	Canada
30	Cara Therapeutics Study Site	Peterborough	Ontario	Canada
31	Cara Therapeutics Study Site	Montréal	Quebec	Canada
32	Cara Therapeutics Study Site	Markham		Canada
33	Cara Therapeutics Study Site	Montréal		Canada
34	Cara Therapeutics Study Site	Peterborough		Canada
35	Cara Therapeutics Study Site	Surrey		Canada
36	Cara Therapeutics Study Site	Winnipeg		Canada