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

Phase 2

Completed

• Conditions: Notalgia Paresthetica; Pruritus
• Interventions: Drug: difelikefalin 2.0 mg; Drug: Placebo

• Registration Number: NCT04706975
• Lead Sponsor: Cara Therapeutics, Inc.

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).

Study Timeline

• Study Start: 2021-01-11
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-13
• Primary Completion: 2022-05-18
• Study Completion: 2022-06-30
• Status Verified: 2023-05
• Disposition First Submitted: 2023-05-17
• Last Update Submitted: 2023-05-17
• Disposition First Posted: 2023-05-22
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Difelikefalin 2.0 mg	difelikefalin 2.0 mg	Oral difelikefalin 2.0 mg tablet administered twice daily
Placebo	Placebo	Oral placebo tablet administered twice daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cara Therapeutics Study Site; 🇨🇦 Winnipeg, Canada