NCT04706975

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Cara Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pruritus
• Notalgia Paresthetica

Interventions

Type	Name	Description
DRUG	difelikefalin 2.0 mg	Oral difelikefalin 2.0 mg administered twice daily
DRUG	Placebo	Oral Placebo administered twice daily

Timeline

• Start date: 2021-01-11
• Primary completion: 2022-05-18
• Completion: 2022-06-30
• First posted: 2021-01-13
• Last updated: 2023-05-22

Locations

36 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study