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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04706975

Enrollment

126

Registered

2021-01-13

Start date

2021-01-11

Completion date

2022-06-30

Last updated

2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Notalgia Paresthetica, Pruritus

Keywords

Notalgia Paresthetica, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, NP, Neuropathic itch

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).

Interventions

DRUGdifelikefalin 2.0 mg

Oral difelikefalin 2.0 mg administered twice daily

DRUGPlacebo

Oral Placebo administered twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026