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

Pruritus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706975
• Other study ID #: CR845-210601
• Status: Completed
• Phase: Phase 2
• Start date: January 11, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2023
• Source: Cara Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: June 30, 2022
• Est. primary completion date: May 18, 2022
• 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 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.

Related Conditions & MeSH terms

• Back Pain
• Notalgia Paresthetica
• Pruritus

Intervention

Drug:
• difelikefalin 2.0 mg
Oral difelikefalin 2.0 mg administered twice daily
• Placebo
Oral Placebo administered twice daily

Locations

Country	Name	City	State
Canada	Cara Therapeutics Study Site	Markham	Ontario
Canada	Cara Therapeutics Study Site	Markham
Canada	Cara Therapeutics Study Site	Montréal
Canada	Cara Therapeutics Study Site	Montréal	Quebec
Canada	Cara Therapeutics Study Site	Peterborough	Ontario
Canada	Cara Therapeutics Study Site	Peterborough
Canada	Cara Therapeutics Study Site	Surrey
Canada	Cara Therapeutics Study Site	Surrey	British Columbia
Canada	Cara Therapeutics Study Site	Winnipeg	Manitoba
Canada	Cara Therapeutics Study Site	Winnipeg
United States	Cara Therapeutics Study Site	Bellaire	Texas
United States	Cara Therapeutics Study Site	Charleston	South Carolina
United States	Cara Therapeutics Study Site	Columbus	Ohio
United States	Cara Therapeutics Study Site	Coral Gables	Florida
United States	Cara Therapeutics Study Site	Cromwell	Connecticut
United States	Cara Therapeutics Study Site	Fort Smith	Arkansas
United States	Cara Therapeutics Study Site	Fountain Valley	California
United States	Cara Therapeutics Study Site	High Point	North Carolina
United States	Cara Therapeutics Study Site	Hot Springs	Arkansas
United States	Cara Therapeutics Study Site	Indianapolis	Indiana
United States	Cara Therapeutics Study Site	Los Angeles	California
United States	Cara Therapeutics Study Site	Margate	Florida
United States	Cara Therapeutics Study Site	Metairie	Louisiana
United States	Cara Therapeutics Study Site	Miami	Florida
United States	Cara Therapeutics Study Site	New York	New York
United States	Cara Therapeutics Study Site	Norfolk	Virginia
United States	Cara Therapeutics Study Site	North Miami Beach	Florida
United States	Cara Therapeutics Study Site	Pflugerville	Texas
United States	Cara Therapeutics Study Site	Plainfield	Indiana
United States	Cara Therapeutics Study Site	Rogers	Arkansas
United States	Cara Therapeutics Study Site	Salt Lake City	Utah
United States	Cara Therapeutics Study Site	San Antonio	Texas
United States	Cara Therapeutics Study Site	San Diego	California
United States	Cara Therapeutics Study Site	Sandy Springs	Georgia
United States	Cara Therapeutics Study Site	Santa Monica	California
United States	Cara Therapeutics Study Site	Spokane	Washington

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 Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8.		Baseline, Week 8
Secondary	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
Secondary	Change from baseline in itch-related Sleep Disturbance Subscale measured by the Itch Medical Outcomes Study (MOS) at Week 8		Baseline, Week 8