Clinical trial NCT04706975: Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pruritus
Notalgia Paresthetica
Keywords: Notalgia Paresthetica
Pruritus
CR845
Chronic Itch
difelikefalin
Itch
Itching
Generalized pruritus
NP
Neuropathic itch
Lead sponsor: Cara Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Change from baseline in the weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8.
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Improvement in itch-related quality of life as assessed by the change from baseline to Week 8 in total Skindex-10 Scale score
timeFrame: Baseline, Week 8
measure: Change from baseline in itch-related Sleep Disturbance Subscale measured by the Itch Medical Outcomes Study (MOS) at Week 8
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Cara Therapeutics Study Site
state: Arkansas
city: Hot Springs
country: United States
facility: Cara Therapeutics Study Site
state: Arkansas
city: Rogers
country: United States
facility: Cara Therapeutics Study Site
state: Arkansas
city: Fountain Valley
country: United States
facility: Cara Therapeutics Study Site
state: California
city: Los Angeles
country: United States
facility: Cara Therapeutics Study Site
state: California
city: San Diego
country: United States
facility: Cara Therapeutics Study Site
state: California
city: Santa Monica
country: United States
facility: Cara Therapeutics Study Site
state: California
city: Cromwell
country: United States
facility: Cara Therapeutics Study Site
state: Connecticut
city: Coral Gables
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Margate
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Miami
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: North Miami Beach
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Sandy Springs
country: United States
facility: Cara Therapeutics Study Site
state: Georgia
city: Indianapolis
country: United States
facility: Cara Therapeutics Study Site
state: Indiana
city: Plainfield
country: United States
facility: Cara Therapeutics Study Site
state: Indiana
city: Metairie
country: United States
facility: Cara Therapeutics Study Site
state: Louisiana
city: New York
country: United States
facility: Cara Therapeutics Study Site
state: New York
city: High Point
country: United States
facility: Cara Therapeutics Study Site
state: North Carolina
city: Columbus
country: United States
facility: Cara Therapeutics Study Site
state: Ohio
city: Charleston
country: United States
facility: Cara Therapeutics Study Site
state: South Carolina
city: Bellaire
country: United States
facility: Cara Therapeutics Study Site
state: Texas
city: Pflugerville
country: United States
facility: Cara Therapeutics Study Site
state: Texas
city: San Antonio
country: United States
facility: Cara Therapeutics Study Site
state: Texas
city: Salt Lake City
country: United States
facility: Cara Therapeutics Study Site
state: Utah
city: Norfolk
country: United States
facility: Cara Therapeutics Study Site
state: Virginia
city: Spokane
country: United States
facility: Cara Therapeutics Study Site
state: Washington
city: Surrey
country: Canada
facility: Cara Therapeutics Study Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Cara Therapeutics Study Site
state: Manitoba
city: Markham
country: Canada
facility: Cara Therapeutics Study Site
state: Ontario
city: Peterborough
country: Canada
facility: Cara Therapeutics Study Site
state: Ontario
city: Montréal
country: Canada
facility: Cara Therapeutics Study Site
state: Quebec
city: Markham
country: Canada
facility: Cara Therapeutics Study Site
city: Montréal
country: Canada
facility: Cara Therapeutics Study Site
city: Peterborough
country: Canada
facility: Cara Therapeutics Study Site
city: Surrey
country: Canada
facility: Cara Therapeutics Study Site
city: Winnipeg
country: Canada
facility: Cara Therapeutics Study Site
Study officials:
affiliation: Cara Therapeutics
name: Nilam Shah
role: STUDY_DIRECTOR
References: