Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 12 for:    difelikefalin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04018027
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : August 12, 2020
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 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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 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 : March 2021
Estimated Study Completion Date : May 2021

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. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Percent of subjects with adverse events. [ Time Frame: Baseline, Week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location contacts
Contact: Georgine Ragsdale 203-406-3700 clinicaltrials.gov@caratherapeutics.com

Locations
Show Show 43 study locations
Sponsors and Collaborators
Cara Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Kristine Nograles Cara Therapeutics
Layout table for additonal information
Responsible Party: Cara Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04018027    
Other Study ID Numbers: CR845-210501
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
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