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

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ClinicalTrials.gov Identifier: NCT04018027
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Cara Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Pruritus Atopic Dermatitis Drug: difelikefalin 0.25 mg Drug: difelikefalin 0.5 mg Drug: difelikefalin 1.0 mg Drug: Placebo Phase 2

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 in a 1:1:1:1 ratio 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 29, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arm Intervention/treatment
Active Comparator: Difelikefalin 0.25 mg
Oral difelikefalin 0.25 mg tablet administered twice daily
Drug: difelikefalin 0.25 mg
Oral difelikefalin 0.25 mg administered twice daily
Other Name: CR845

Active Comparator: Difelikefalin 0.5 mg
Oral difelikefalin 0.5 mg tablet administered twice daily
Drug: difelikefalin 0.5 mg
Oral difelikefalin 0.5 mg administered twice daily
Other Name: CR845

Active Comparator: Difelikefalin 1.0 mg
Oral difelikefalin 1.0 mg tablet administered twice daily
Drug: difelikefalin 1.0 mg
Oral difelikefalin 1.0 mg administered twice daily
Other Name: CR845

Placebo Comparator: Placebo
Oral placebo tablet administered twice daily
Drug: Placebo
Oral Placebo administered twice daily




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Percent of subjects with adverse events. [ Time Frame: Baseline, Week 12 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018027


Contacts
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Contact: Georgine Ragsdale 203-406-3700 clinicaltrials.gov@caratherapeutics.com

Locations
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United States, Alabama
Cara Therapeutics Study Site Recruiting
Birmingham, Alabama, United States, 35209
United States, Arkansas
Cara Therapeutics Study Site Recruiting
Bryant, Arkansas, United States, 72022
United States, California
Cara Therapeutics Study Site Recruiting
Fountain Valley, California, United States, 92708
Cara Therapeutics Study Site Recruiting
Lomita, California, United States, 90717
United States, Florida
Cara Therapeutics Study Site Recruiting
Miami, Florida, United States, 33174
Cara Therapeutics Study Site Recruiting
Sweetwater, Florida, United States, 33172
United States, Idaho
Cara Therapeutics Study Site Recruiting
Boise, Idaho, United States, 83704
Cara Therapeutics Study Site 2 Recruiting
Boise, Idaho, United States, 83713
United States, Louisiana
Cara Therapeutics Study Site Recruiting
Baton Rouge, Louisiana, United States, 70809
Cara Therapeutics Study Site Recruiting
New Orleans, Louisiana, United States, 70115
United States, Nevada
Cara Therapeutics Study Site Recruiting
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Cara Therapeutics Study Site Recruiting
Berlin, New Jersey, United States, 08009
United States, New York
Cara Therapeutics Study Site Recruiting
Forest Hills, New York, United States, 11375
United States, Ohio
Cara Therapeutics Study Site Recruiting
Cleveland, Ohio, United States, 44122
United States, Oklahoma
Cara Therapeutics Study Site Recruiting
Oklahoma City, Oklahoma, United States, 73118
Cara Therapeutics Study Site Recruiting
Tulsa, Oklahoma, United States, 74136
United States, South Dakota
Cara Therapeutics Study Site Recruiting
Rapid City, South Dakota, United States, 57702
United States, Texas
Cara Therapeutics Study Site Recruiting
Austin, Texas, United States, 78759
United States, Utah
Cara Therapeutics Study Site Recruiting
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
Cara Therapeutics, Inc.
Investigators
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Study Director: Kristine Nograles Cara Therapeutics

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Responsible Party: Cara Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04018027     History of Changes
Other Study ID Numbers: CR845-210501
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cara Therapeutics, Inc.:
Atopic Dermatitis
Pruritus
CR845
Chronic Itch
difelikefalin
Itch
Itching
Generalized pruritus
Eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations
Signs and Symptoms