Clinical trial NCT04018027: Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Adult Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pruritus
Atopic Dermatitis
Keywords: Atopic Dermatitis
Pruritus
CR845
Chronic Itch
difelikefalin
Itch
Itching
Generalized pruritus
Eczema
Lead sponsor: Cara Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-12
Enrollment: 401
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, 4-arm, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with atopic dermatitis (AD) and moderate to severe pruritus.

Detailed description: The study will consist of a 30-day Screening period, a 7-day Run-In period, a 12-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 7 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 0.25 mg, 0.5 mg, or 1.0 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 upon completion of the Week 12 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 AD;
* Subject has at least a 12-month history of AD;
* Subject has chronic itch related to AD;
* 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 clinically infected AD;
* Subject has pruritus attributed to a cause other than AD;
* 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 Itch-Numeric Rating Scale (I-NRS) score at Week 12.
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Reduction of itch intensity as assessed by the proportion of patients achieving an improvement from baseline ≥4 points with respect to the weekly mean of the daily 24-hour I-NRS score at Week 12
timeFrame: Week 12
measure: Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in 5-D Itch Scale score
timeFrame: Baseline, Week 12
measure: Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in total Skindex-10 Scale score
timeFrame: Baseline, Week 12
measure: Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in Sleep Quality Assessment.
timeFrame: Baseline, Week 12
measure: Percent of subjects with adverse events.
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Cara Therapeutics Study Site
state: Alabama
city: Birmingham
country: United States
facility: Cara Therapeutics Study Site
state: Alabama
city: Scottsdale
country: United States
facility: Cara Therapeutics Study Site
state: Arizona
city: Bryant
country: United States
facility: Cara Therapeutics Study Site
state: Arkansas
city: Fountain Valley
country: United States
facility: Cara Therapeutics Study Site
state: California
city: Lomita
country: United States
facility: Cara Therapeutics Study Site
state: California
city: Cromwell
country: United States
facility: Cara Therapeutics Study Site
state: Connecticut
city: Farmington
country: United States
facility: Cara Therapeutics Study Site
state: Connecticut
city: Aventura
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Miami Lakes
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Miami
country: United States
facility: Cara Therapeutics Study Site 2
state: Florida
city: Miami
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Ocala
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Sarasota
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Sweetwater
country: United States
facility: Cara Therapeutics Study Site
state: Florida
city: Columbus
country: United States
facility: Cara Therapeutics Study Site
state: Georgia
city: Boise
country: United States
facility: Cara Therapeutics Study Site
state: Idaho
city: Boise
country: United States
facility: Cara Therapeutics Study Site 2
state: Idaho
city: Baton Rouge
country: United States
facility: Cara Therapeutics Study Site
state: Louisiana
city: Metairie
country: United States
facility: Cara Therapeutics Study Site
state: Louisiana
city: New Orleans
country: United States
facility: Cara Therapeutics Study Site
state: Louisiana
city: Brighton
country: United States
facility: Cara Therapeutics Study Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Cara Therapeutics Study Site 2
state: Nevada
city: Berlin
country: United States
facility: Cara Therapeutics Study Site
state: New Jersey
city: Horseheads
country: United States
facility: Cara Therapeutics Study Site
state: New York
city: New York
country: United States
facility: Cara Therapeutics Study Site
state: New York
city: New York
country: United States
facility: Cara Therapeutics Study Site
state: New York
city: Cleveland
country: United States
facility: Cara Therapeutics Study Site
state: Ohio
city: Oklahoma City
country: United States
facility: Cara Therapeutics Study Site
state: Oklahoma
city: Tulsa
country: United States
facility: Cara Therapeutics Study Site
state: Oklahoma
city: Medford
country: United States
facility: Cara Therapeutics Study Site
state: Oregon
city: Rapid City
country: United States
facility: Cara Therapeutics Study Site
state: South Dakota
city: Austin
country: United States
facility: Cara Therapeutics Study Site 2
state: Texas
city: Austin
country: United States
facility: Cara Therapeutics Study Site
state: Texas
city: Cypress
country: United States
facility: Cara Therapeutics Study Site
state: Texas
city: Dallas
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: Richmond
country: United States
facility: Cara Therapeutics Study Site
state: Virginia
city: London
country: Canada
facility: Cara Therapeutics Study Site
state: Ontario
city: Montréal
country: Canada
facility: Cara Therapeutics Study Site
state: Quebec
Study officials:
affiliation: Cara Therapeutics
name: Kristine Nograles
role: STUDY_DIRECTOR
References: