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

Short name KARE

NCTNCT04018027Other idCR845-210501

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 401 participants (actual)
Sponsor: Cara Therapeutics, Inc. · Industry
Design: Randomized · Double masking
Countries: 2 countries
United States, Canada
Start: 29 Jun 2019
Primary completion: 1 Apr 2021
Completion: 1 Apr 2021
First posted: 12 Jul 2019
Last update posted: 4 Apr 2022
Conditions: Pruritus · Atopic Dermatitis

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2019202020212022

Ph 2
KARE
NCT04018027
29 Jun 2019 to 1 Apr 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

difelikefalin 0.25 mgDrug
difelikefalin 0.5 mgDrug
difelikefalin 1.0 mgDrug
PlaceboDrug

Arms4

Active comparator
Difelikefalin 0.25 mg
Oral difelikefalin 0.25 mg tablet administered twice daily
Active comparator
Difelikefalin 0.5 mg
Oral difelikefalin 0.5 mg tablet administered twice daily
Active comparator
Difelikefalin 1.0 mg
Oral difelikefalin 1.0 mg tablet administered twice daily
Placebo comparator
Placebo
Oral placebo tablet administered twice daily

Primary outcomes1

Outcomes the sponsor listed as primary.

Change from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 12.
Time frame · Baseline, Week 12

Secondary outcomes(5)

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
Time frame · Week 12
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in 5-D Itch Scale score
Time frame · Baseline, Week 12
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in total Skindex-10 Scale score
Time frame · Baseline, Week 12
Improvement in itch-related quality of life as assessed by the change from baseline to Week 12 in Sleep Quality Assessment.
Time frame · Baseline, Week 12
Percent of subjects with adverse events.
Time frame · Baseline, Week 12

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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